chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: F
Vaccine: DTP, IPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: PENTACEL and IPOL were incorrectly administered to a patient and vaccines to be given was suppose to be a Dtap and Polio with no reported AE; extra dose of IPV was given with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from nurse.  This case involves a 13 months old female patient who incorrectly administered to IPV (Vero) [IPOL] and pentacel was suppose to be a Diphtheria, Tetanus And Nos Pertussis Vaccine and Polio and extra dose of IPV was given with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Hib Vaccine Conj (Tet Tox), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Mrc 5), Tetanus Vaccine Toxoid (Pentacel) for Immunisation on 02-jun-2025.  On 02-Jun-2025, the patient received 0.5mL of suspect IPV (Vero), Suspension for injection (lot X1C891M, expiry date 31-Oct-2026, strength standard and frequency once) via subcutaneous route in the left arm for Immunization.  On an unknown date, the patient was suppose to received Diphtheria, Tetanus And Nos Pertussis Vaccine produced by unknown manufacturer (lot number, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On 02-Jun-2025, the patient was incorrectly administered with IPV (Vero) and pentacel and was suppose to be a Diphtheria And Tetanus And Nos Pertussis Vaccine and polio with no reported ae (wrong product administered) and extra dose of ipv was given with no reported adverse event (extra dose administered) (latency same day).  Reportedly, patient's Hib vaccine was scheduled in October 2025 since it was given last April 2025.  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.; Sender's Comments:  US-SA-2025SA157483:
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered ACTHIB today that expired with no reported AE; Initial information received on 03-Jun-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who had administered expired hib (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Jun-2025, the patient received an unknown expired  dose of suspect hib (PRP/T) vaccine, Powder and solvent for solution for injection, lot UK092AA,expiry date:31-May-2025, strength not reported via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (latency: same day).   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: 0.92
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 11-month old patient received quadracel instead of pentacel with no reported adverse event; Initial information received on 03-Jun-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case involves a 11 months old male patient who received diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (vero) vaccine [Quadracel] instead of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-May-2025, the patient received 0.5 ml dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (vero) vaccine Solution for injection lot U8209CB and expiry date- 31-MAY-2026 via intramuscular route in the left vastus lateralis instead of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot number not reported with no reported adverse event (wrong product administered) (latency- same day).  Action taken -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: 16.0
Sex: F
Vaccine: UNK
Symptoms: Cold flash, Dysphagia, Hot flush, Pain, Pyrexia
Clinical narrative: Meningococcal vaccine - Dr mentioned its the one required for college entry.  Side effects 1 day after vaccine included:  Low fever, vomited one time today (reported same day as symptoms occurred), hot and cold flashes, slight rash, can't swallow, hands shaking, vision goes faint, body aches.  Patient is 16 years old and had prior hospitalization from MMR + chickenpox vaccine when she was 2.  Patient was not sick prior to getting vaccine and was healthy.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Tremor, Visual impairment, Vomiting
Clinical narrative: Meningococcal vaccine - Dr mentioned its the one required for college entry.  Side effects 1 day after vaccine included:  Low fever, vomited one time today (reported same day as symptoms occurred), hot and cold flashes, slight rash, can't swallow, hands shaking, vision goes faint, body aches.  Patient is 16 years old and had prior hospitalization from MMR + chickenpox vaccine when she was 2.  Patient was not sick prior to getting vaccine and was healthy.
Age: 23.0
Sex: M
Vaccine: RAB, SMALLMNK
Symptoms: Depressed level of consciousness, Dizziness, Eye swelling, Headache, Muscle twitching
Clinical narrative: Twitching in neck, back and shoulders, lasted for 12 hours day 1 following injection. Swollen right eye lasted for 12 hours day 3 following injection. Dizziness, headache, soreness behind eyes, lack of alertness, minor swelling of throat.
Age: 23.0
Sex: M
Vaccine: RAB, SMALLMNK
Symptoms: Pharyngeal swelling
Clinical narrative: Twitching in neck, back and shoulders, lasted for 12 hours day 1 following injection. Swollen right eye lasted for 12 hours day 3 following injection. Dizziness, headache, soreness behind eyes, lack of alertness, minor swelling of throat.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Endoscopy normal, Gait inability
Clinical narrative: Sick with fever aches 12/25/24. Jan 7, 2024 got SO SICK.  Out of school the rest of the year due to extreme nausea. Pale. Vagus nerve affected. Nerves affected. Couldn?t walk after Feb 2024.  Saw specialist. Every test normal. X-rays, ultra sounds, ct scans, blood work all normal. Saw Neuro. Cardiologist, and GI. Spent a week in the hospital. Finally a clinic in (redacted state) helped us! They believe it was vaccine injury, and she started seeing a chiropractor and (redacted) put her on special diet medication and supplements.  Finally a lot better but not able to run. A very healthy 11 year old robbed of half of her 5th grade year.  That was very scary. Very bizarre. And made no sense at all.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Loss of personal independence in daily activities, Malaise, Nausea, Nervous system disorder, Pain
Clinical narrative: Sick with fever aches 12/25/24. Jan 7, 2024 got SO SICK.  Out of school the rest of the year due to extreme nausea. Pale. Vagus nerve affected. Nerves affected. Couldn?t walk after Feb 2024.  Saw specialist. Every test normal. X-rays, ultra sounds, ct scans, blood work all normal. Saw Neuro. Cardiologist, and GI. Spent a week in the hospital. Finally a clinic in (redacted state) helped us! They believe it was vaccine injury, and she started seeing a chiropractor and (redacted) put her on special diet medication and supplements.  Finally a lot better but not able to run. A very healthy 11 year old robbed of half of her 5th grade year.  That was very scary. Very bizarre. And made no sense at all.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Pallor, Pyrexia, Ultrasound scan normal, Vagus nerve disorder, X-ray normal
Clinical narrative: Sick with fever aches 12/25/24. Jan 7, 2024 got SO SICK.  Out of school the rest of the year due to extreme nausea. Pale. Vagus nerve affected. Nerves affected. Couldn?t walk after Feb 2024.  Saw specialist. Every test normal. X-rays, ultra sounds, ct scans, blood work all normal. Saw Neuro. Cardiologist, and GI. Spent a week in the hospital. Finally a clinic in (redacted state) helped us! They believe it was vaccine injury, and she started seeing a chiropractor and (redacted) put her on special diet medication and supplements.  Finally a lot better but not able to run. A very healthy 11 year old robbed of half of her 5th grade year.  That was very scary. Very bizarre. And made no sense at all.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Injection site reaction, Muscle spasms, Syncope
Clinical narrative: Deltoid muscle cramps were observed by the pharmacist on the injection arm as soon as the 0.5 ml of intramuscular MenACWY shot started. The patient fainted about a minute after receiving the shot. The patient was hold and placed in supine position on the floor, but quickly recover within a minute of fainting. After that the patient was alert and able to talk. He was closely observed by the pharmacist for 15 minutes with no symptoms and let go home at his request. His mom said he had once fainted after an injection but not with a vaccine. I think it could well be a vasovagal syncope rather than a reaction to the vaccine.
Age: 37.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Nausea, emesis, mild headache
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Drainage, Fatigue, Intensive care, Malaise, Sepsis
Clinical narrative: Tired, sick almost every few weeks
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Tooth infection, Tracheostomy
Clinical narrative: Tired, sick almost every few weeks
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Back pain, Blood creatine phosphokinase normal, Blood electrolytes normal, Blood thyroid stimulating hormone normal
Clinical narrative: 7 hours after vaccine administration, patient developed body aches, chills, weakness, nasal congestion, severe myalgias of legs, arms, and back, tremors, severe headache, chest pain & difficulty breathing. Tests done in ER-normal WBC, normal electrolytes, EKG nl. Normal saline bolus given & Toradol. Pt. discharged on Naproxen. F/u 5/21 pt. improved.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chest pain, Chills, Dyspnoea, Electrocardiogram normal, Full blood count normal
Clinical narrative: 7 hours after vaccine administration, patient developed body aches, chills, weakness, nasal congestion, severe myalgias of legs, arms, and back, tremors, severe headache, chest pain & difficulty breathing. Tests done in ER-normal WBC, normal electrolytes, EKG nl. Normal saline bolus given & Toradol. Pt. discharged on Naproxen. F/u 5/21 pt. improved.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Myalgia, Nasal congestion, Pain, Thyroxine free normal, Viral test negative
Clinical narrative: 7 hours after vaccine administration, patient developed body aches, chills, weakness, nasal congestion, severe myalgias of legs, arms, and back, tremors, severe headache, chest pain & difficulty breathing. Tests done in ER-normal WBC, normal electrolytes, EKG nl. Normal saline bolus given & Toradol. Pt. discharged on Naproxen. F/u 5/21 pt. improved.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: White blood cell count normal
Clinical narrative: 7 hours after vaccine administration, patient developed body aches, chills, weakness, nasal congestion, severe myalgias of legs, arms, and back, tremors, severe headache, chest pain & difficulty breathing. Tests done in ER-normal WBC, normal electrolytes, EKG nl. Normal saline bolus given & Toradol. Pt. discharged on Naproxen. F/u 5/21 pt. improved.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Influenza like illness, Influenza virus test negative, Malaise, Nausea
Clinical narrative: Patient developed nausea, headache 5 1/2 hours later. This AM (24 hours later) she developed fever, Tmax=103.6, malaise, headache, arm pain, flu-like symptoms. Office testing negative for flu & Covid.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Patient developed nausea, headache 5 1/2 hours later. This AM (24 hours later) she developed fever, Tmax=103.6, malaise, headache, arm pain, flu-like symptoms. Office testing negative for flu & Covid.
Age: 58.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site pain
Clinical narrative: Patient experienced prolonged injection site pain after vaccination.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Constipation, Diarrhoea, Hysterectomy, Pelvic floor muscle weakness
Clinical narrative: Constipation, diarrhea, internal shaking, weakness. Symptoms continue to get worse (I have been to clinic- 2023-week pelvic floor, University 2x- pills for constipation, tried Naturopathic diet, Hysterectomy-04/2025)
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Constipation, diarrhea, internal shaking, weakness. Symptoms continue to get worse (I have been to clinic- 2023-week pelvic floor, University 2x- pills for constipation, tried Naturopathic diet, Hysterectomy-04/2025)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiovascular symptom, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Had all shots & boosters- After this Booster  It wasn't until last of April & May 2023 I started symptoms like heart attac chest tightness. Went to (redacted) ER first  gave me aspirin & check heart. A week later went back with more severe pain. They called heart Dr who ordered Echo gram & gave pain for shot. Had Echogram then while waiting for results went to (redacted) Hosp ER. At (redacted) I was in severe pain chest. They knew I had pericarditis so gave me pain med and said told me to see heart Dr next week. I did and he gave me medication 8 ibuprofen a day for 1 month an Colchicine for 2 months. But the time I got home at 4pm I just took 1st dose. My R shoulder started to hurt. I said I think it started here now. By 8 pm I hurt like in a vice from neck to waist and had to bend to knees to breath. Husband called ambulance and they sent that & air lift from home to (redacted) ER  was admitted for 5 day stay at (redacted) Hosp center. After Booster on 9/22/23  10 days & after I had recurrent Pericarditis. Saw at (redacted) Hosp. ER  started 6 mo treatment as before  Saw Heart Dr. did more recheck all possible inflammation with Dr then 2 wk 1 Dr  called and has me on ARC just > 200 shots q week. Past Covid19 Vaccination Moderna 007M20A 2/13/21 (redacted name) Pharmacy Moderna 040A21A 3/13/21 (redacted name) Pharmacy Moderna 037F21A 10/27/21 (redacted name) Family Health Clinic Moderna AS7143C 9/22/22 (redacted name) Health Dept. Moderna 3030371 9/22/23 (redacted name) Pharmacy
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Pain, Pericarditis
Clinical narrative: Had all shots & boosters- After this Booster  It wasn't until last of April & May 2023 I started symptoms like heart attac chest tightness. Went to (redacted) ER first  gave me aspirin & check heart. A week later went back with more severe pain. They called heart Dr who ordered Echo gram & gave pain for shot. Had Echogram then while waiting for results went to (redacted) Hosp ER. At (redacted) I was in severe pain chest. They knew I had pericarditis so gave me pain med and said told me to see heart Dr next week. I did and he gave me medication 8 ibuprofen a day for 1 month an Colchicine for 2 months. But the time I got home at 4pm I just took 1st dose. My R shoulder started to hurt. I said I think it started here now. By 8 pm I hurt like in a vice from neck to waist and had to bend to knees to breath. Husband called ambulance and they sent that & air lift from home to (redacted) ER  was admitted for 5 day stay at (redacted) Hosp center. After Booster on 9/22/23  10 days & after I had recurrent Pericarditis. Saw at (redacted) Hosp. ER  started 6 mo treatment as before  Saw Heart Dr. did more recheck all possible inflammation with Dr then 2 wk 1 Dr  called and has me on ARC just > 200 shots q week. Past Covid19 Vaccination Moderna 007M20A 2/13/21 (redacted name) Pharmacy Moderna 040A21A 3/13/21 (redacted name) Pharmacy Moderna 037F21A 10/27/21 (redacted name) Family Health Clinic Moderna AS7143C 9/22/22 (redacted name) Health Dept. Moderna 3030371 9/22/23 (redacted name) Pharmacy
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms reported and no additional details provided. No other AE/PQC; Caller states a patient received 3 pediatric doses prior to the age of 19, however the third dose was administered too early at 4 months instead of 6 months.; Caller states the office inadvertently administered another 0.5ml dose instead of a 1.0 ml dose; This spontaneous report was received from a nurse and refers to an adult patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On unspecified dates, prior to the age of 19, the patient was administered 3 pediatric does of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 0,5 ml administered intramuscularly for prophylaxis (lot # and expiry dates were not provided), however third dose was administered too early at 4 months instead of 6 months (inappropriate schedule of product administration). The reporter stated that as a result, the office chose to administer a booster dose to this patient that was now an adult and who already received 3 pediatric doses.  On 13-May-2025, the patient was administered the fourth dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot #Y009551, expiration date: 08-Dec-2026) 0.5 mL administered intramuscularly for prophylaxis. The office inadvertently administered another 0.5ml dose instead of a 1.0 ml dose (accidental underdose). No symptoms were reported and no additional details were provided. No other adverse event (AE) or product quality complaint (PQC) was noted (no adverse event).
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Nurse confirmed their facility has not received any reports of the patient involved experiencing any medical concerns or side effects after being administered the improperly stored dose of MMR II.; Nurse calling with a report of an adverse event regarding an improperly stored and administered dose of MMR II.  Nurse stated that the MMR II was involved in a temperature excursion on 3/4/2025 and administered to a patient on 3/31/2025; This spontaneous report was received from Nurse and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 04-Mar-2025, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #Y005808, expiration date: 12-Mar-2026) was involved in a temperature excursion and on 31-Mar-2025, the patient received 0.5 mL, of a two dose series of the improperly storage Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength and route of administration not provided) diluted with therapy with sterile diluent (MERCK STERILE DILUENT), 0.5 mL (indication, expiration date, and lot # were not reported) for prophylaxis. Nurse confirmed their facility had not received any reports of the patient involved experiencing any medical concerns or side effects after being administered the improperly stored dose of vaccine.
Vaccine: PNC21
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: redness, and swelling at the injection site; redness, and swelling at the injection site; inflammation/redness, and swelling at the injection site; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date in May 2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 0.5 ml (reported as 0.5 m) intramuscularly (anatomical location, lot # and expiration date were not provided) for prophylaxis.  Since an unknown date in May 2025, post the suspect vaccination ,the patient suffered from redness, and swelling at the injection site. The area of redness and swelling stretched about 3 inches across and about 4-5 inches wide. The reporter noted inflammation but stated it did not appear to be infected. The patient sought medical attention. At the time of the report, the patient suffered from the events for at least 6 days. The outcome of the events was reported as not recovered.  Causality assessment was not provided.  Lot # is being requested and will be submitted if received. This is an invalid report due to lack of the patient's identifiers.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; A HCP called to report the administration of an expired dose of MMR II (Lot: X014954 Expiration: 05/24/2025) that occurred on 05/28/2025. The HCP stated the patient did not experience any adverse issues or side effect from the expired administered do; This spontaneous report was received from a nurse and refers to a 1-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-May-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X014954, expiration date: 24-May-2025) 0.5 mL for an unknown indication. On 28-May-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported) (Expired vaccine used). No additional adverse event reported.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No side effects or symptoms reported; HCP called to report a patient received an expired dose of VARIVAX. The product expired 04/30/2025 and was administered 06/02/2025.  Caller verified the product has not had any temperature excursions. No side effects or symptoms reported. No addition; This spontaneous report was received from a medical assistant and refers to a 5-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 02-Jun-2025, the patient was vaccinated with an expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #X012268, expiration date: 30-Apr-2025), dose number 1, 0.5 mL, that was reconstituted with sterile diluent for prophylaxis (expired product administered). No adverse event was reported.
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; an expired dose of MMRII; MMRII has also had a supported temperature excursion in the past of 13.7°C for 2 Hours 0 Minutes 0 Seconds; This spontaneous report was received from a Physician and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 04-Jun-2025, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection (lot #X013192, expiration date: 08-May-2025) (Expired product administered) with sterile diluent (lot # and expiration date were not reported) for prophylaxis. This vaccine has also had a supported temperature excursion in the past of 13.7 degree Celsius for 2 Hours 0 Minutes 0 Seconds (Product storage error). No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: adverse reaction that consisted of a uh severe rash all throughout her body; This spontaneous report has been received from a healthcare professional regarding a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered as prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported).  On an unknown date, the patient experienced an adverse reaction that consisted of a severe rash all throughout her body (Rash). On an unknown date, the patient recovered from the event.  The reporter considered the event of rash to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9).
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: schedule recommendations for GARDASIL 9/patient received their first dose at age 11 and their second dose at age 18; No additional AE/No PQC.; This spontaneous report was received from a/an Nurse and refers to a(n) female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (.5 ml), (lot # and expiration date were not reported). The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), for the treatment of Prophylaxis.  HCP called for information regarding alternate dosing schedule recommendations for Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). HCP stated that a female patient received their first dose at age 11 and their second dose at age 18. No additional patient information available at the time of the call. No symptoms reported at the time of the call. Consent to contact is Yes. No additional AE/No PQC.  Lot # is being requested and will be submitted if received.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Headache, Injection site haemorrhage, Injection site rash, Pain in extremity
Clinical narrative: got an itchy rash, size of a dime, near the injection site; got an itchy rash, size of a dime, near the injection site; I've had minor headaches the last few days; bleeding during the injection; I got a sore arm; bruised arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 75d3a, expiry date 31-MAR-2027) for prophylaxis.   The patient's past medical history included shingles (Mild case of shingles in the past). Concurrent medical conditions included thyroid disorder. Concomitant products included levothyroxine sodium (Levothyroxine).   On 21-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). In MAY-2025, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: I got a sore arm) and bruising of arm (Verbatim: bruised arm). On 21-MAY-2025, the patient experienced injection site hemorrhage (Verbatim: bleeding during the injection). On 27-MAY-2025, the patient experienced injection site rash (Verbatim: got an itchy rash, size of a dime, near the injection site), injection site itching (Verbatim: got an itchy rash, size of a dime, near the injection site) and headache (Verbatim: I've had minor headaches the last few days). The patient was treated with ibuprofen sodium (Ibuprofen). On 28-MAY-2025, the outcome of the headache was resolved (duration 1 day). The outcome of the injection site rash and injection site itching were not resolved and the outcome of the injection site hemorrhage, pain in arm and bruising of arm were unknown.   It was unknown if the reporter considered the injection site rash, injection site itching, injection site hemorrhage, pain in arm, bruising of arm and headache to be related to Shingrix.     It was unknown if the company considered the injection site rash, injection site itching, injection site hemorrhage, pain in arm, bruising of arm and headache to be related to Shingrix.   Additional Information: GSK Receipt Date : 28-MAY-2025 The patient received Shingrix and experienced sore and bruised arm.  The day before reporting, she got an itchy rash, size of a dime, near the injection site.  She had minor headaches the last few days, treatable with ibuprofen. Then the patient was called and she provided further details.  She stated that she took a photo of the rash yesterday when it showed up.  She mentioned that it was very itchy.  The Shingrix shot number one was administered intramuscularly in the upper right arm and there was bleeding during the injection.  She indicated that this was unusual as she normally did not bleed during a vaccination.  She was not on aspirin. She indicated that she had a mild headache yesterday and also on the day of reporting. Each headache was treated with ibuprofen and resolved. She stated that headaches were uncommon for her, she said she hardly got headaches.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: got an itchy rash, size of a dime, near the injection site; got an itchy rash, size of a dime, near the injection site; I've had minor headaches the last few days; bleeding during the injection; I got a sore arm; bruised arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 75d3a, expiry date 31-MAR-2027) for prophylaxis.   The patient's past medical history included shingles (Mild case of shingles in the past). Concurrent medical conditions included thyroid disorder. Concomitant products included levothyroxine sodium (Levothyroxine).   On 21-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). In MAY-2025, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: I got a sore arm) and bruising of arm (Verbatim: bruised arm). On 21-MAY-2025, the patient experienced injection site hemorrhage (Verbatim: bleeding during the injection). On 27-MAY-2025, the patient experienced injection site rash (Verbatim: got an itchy rash, size of a dime, near the injection site), injection site itching (Verbatim: got an itchy rash, size of a dime, near the injection site) and headache (Verbatim: I've had minor headaches the last few days). The patient was treated with ibuprofen sodium (Ibuprofen). On 28-MAY-2025, the outcome of the headache was resolved (duration 1 day). The outcome of the injection site rash and injection site itching were not resolved and the outcome of the injection site hemorrhage, pain in arm and bruising of arm were unknown.   It was unknown if the reporter considered the injection site rash, injection site itching, injection site hemorrhage, pain in arm, bruising of arm and headache to be related to Shingrix.     It was unknown if the company considered the injection site rash, injection site itching, injection site hemorrhage, pain in arm, bruising of arm and headache to be related to Shingrix.   Additional Information: GSK Receipt Date : 28-MAY-2025 The patient received Shingrix and experienced sore and bruised arm.  The day before reporting, she got an itchy rash, size of a dime, near the injection site.  She had minor headaches the last few days, treatable with ibuprofen. Then the patient was called and she provided further details.  She stated that she took a photo of the rash yesterday when it showed up.  She mentioned that it was very itchy.  The Shingrix shot number one was administered intramuscularly in the upper right arm and there was bleeding during the injection.  She indicated that this was unusual as she normally did not bleed during a vaccination.  She was not on aspirin. She indicated that she had a mild headache yesterday and also on the day of reporting. Each headache was treated with ibuprofen and resolved. She stated that headaches were uncommon for her, she said she hardly got headaches.
Sex: F
Vaccine: RSV
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; Patient got RSV six months after arexvy dose; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 6 months after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Patient got RSV six months after arexvy dose). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was unknown.   The reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.     The company considered the vaccination failure to be unrelated to Arexvy. The company considered the respiratory syncytial virus infection to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-JUN-2025 The patient got respiratory syncytial virus infection (RSV) six months after Arexvy dose. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding respiratory syncytial virus infection 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, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Arexvy.
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: slightly sore arm; feel a bit under the weather; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of pruritus (received in 2012 and had arm itch for a week), Shingrix with an associated reaction of malaise (received first dose in 2018 for tolerance of first dose refer case US2025AMR070529), Pneumovax 23 with an associated reaction of pain in extremity and Prevenar 20 with an associated reaction of pain in extremity.   On an unknown date, the patient received the 2nd dose of Shingrix and Arexvy. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Arexvy, the patient experienced feeling unwell (Verbatim: feel a bit under the weather) and pain in arm (Verbatim: slightly sore arm). Rechallenge with Shingrix was positive. The outcome of the feeling unwell was resolved (duration 36 hrs) and the outcome of the pain in arm was not reported.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix. It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the feeling unwell to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Arexvy.   Linked case(s) involving the same patient:  US2025AMR070529   Additional Information: GSK Receipt Date: 28-MAY-2025 Patient received both Zostavax in 2012 and two doses of Shingrix in 2018.  Zostavax, which is not much used these days, made her arm itch for a week and Shingrix made her feel a bit under the weather the day.  She was fine after 24-36 hours, and after watching what her husband's  mother went through with multiple bouts of shingles, she consider it was completely worth it. She had two different pneumonia vaccines, Pneumovax 23 and Prevnar 20.  She was also in the Pfizer adult RSV clinical trial a few years back, but since they were not ready to unblind her, she just went ahead and got the Arexvy shot a year later.  None of those shots gave her anything worse than a slightly sore arm. This case is linked with case US2025AMR070488, reporter by the same reporter.; Sender's Comments:  US-GSK-US2025AMR070488:same reporter/male patient
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Urticaria
Clinical narrative: I did have swollen arm at injection site; very sore at injection site; My question is if it is known to cause hives what do the hives look like ,Because I am breaking out it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling 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 injection site swelling (Verbatim: I did have swollen arm at injection site), injection site pain (Verbatim: very sore at injection site) and hives (Verbatim: My question is if it is known to cause hives what do the hives look like ,Because I am breaking out it). The outcome of the injection site swelling and injection site pain were resolving and the outcome of the hives was not reported.   It was unknown if the reporter considered the injection site swelling, injection site pain and hives to be related to Shingles vaccine.     It was unknown if the company considered the injection site swelling, injection site pain and hives to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAY-2025 This case was reported by a patient via (Chatbot) interactive digital media. The patient reported that had a recent vaccination for Shingles and had read the side effects.  The patient had a very sore and swollen arm at injection site , but it has gone down .  The patient wanted to ask question if it was known to cause hives what the hives looked like, because he/she breaking out it.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Had both shots still got 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had both shots still got the 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: 03-JUN-2025 This case was reported by a patient via interactive digital media. The patient had received both shots and still got the shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2).
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: felt more like he had case of flu; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of influenza in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza (Verbatim: felt more like he had case of flu). The outcome of the influenza was resolved (duration 36 hrs).   It was unknown if the reporter considered the influenza to be related to Shingrix.     It was unknown if the company considered the influenza to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAY-2025 Reporter stated that after receiving Shingrix they felt more like patient had a case of flu. This case is linked with case US2025AMR066426, reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR066426:same reporter/female patient
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: feel a bit under the weather; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of pruritus (received in 2012 and had arm itch for a week).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced feeling unwell (Verbatim: feel a bit under the weather). The outcome of the feeling unwell was resolved (duration 36 hrs).   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR066426   Additional Information: GSK Receipt Date: 28-MAY-2025 Patient received first dose of Shingrix in 2018, which made her feel a bit under the weather on the day after. She was fine after 24-36 hours.; Sender's Comments:  US-GSK-US2025AMR070488:same reporter/male patient US-GSK-US2025AMR066426:same patient/second dose
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: I accidentally gave the patient an extra dose of this vaccine because i did not realize her first dose was given when she was 12 years old. She would have only needed 2 doses.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Fatigue, soreness, headaches lasting multiple days
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient did not need third dose.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Tender nodule in left deltoid, that measure 0.25 inch without: erythema, induration, swelling, and discoloration. Clinical Notes: May likely be lipohypertrophy or granulation due to HPV vaccine. Unlikely lipoma. No signs of infection or injury.                                        Treatment: NSAIDs PRN and apply ice & heat. Recommended to RTC in 1 month for re-evaluation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child inadvertently received an extra dose of vaccine. No signs or symptoms of adverse outcome at this time.
Age: 68.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Vaccination error
Clinical narrative: Patient was administered a 3rd MenQuadfi dose in error
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: My baby was vaccinated at 6 months and 1 yr old; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: My baby was vaccinated at 6 months and 1 yr 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:02-JUN-2025 The patient was vaccinated with Bexsero at 6 months and 1 year old and asked if he need additional shots, which led to inappropriate age at vaccine administration.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: received covid vaccine on 6/3/2025 fever of 101.6 identified on 06/04/2025 with chills and body aches resolved with prn Tylenol 500 mg
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: a TDAP vaccine was given to a patient that had expired in 12/2024.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Abnormal behaviour, Sleep disorder
Clinical narrative: The mother reports that on the same day (04/15/2025) that the patient received his vaccines his behavior changed:  1) his normal crying and babbling sounds were reduced to muffled moans; 2) his usual calm behavior, for example, during breast feeding, changed to hitting, biting and clawing actions 'as if desperate'; 3) he was clingy and didn't want to be put down; 4)he was no longer sleeping well.  The mother brought the patient back into the office on 05/01/2025 because these behaviors had persisted for over 2 weeks and she was concerned that they were vaccine-related.  The mother reports that she noted that the patient's behaviors had fully returned to normal when she heard the patient cry normally on 05/05/2025.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given incorrect vaccine.  Patient given MenB-FHbp (Trumemba).  Order was for MenACWY-TT (MenQuadfi).  No adverse affect to the patient.  No harm to the patient.