chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Underdose
Clinical narrative: When the vaccine was being administered, the patient moved his arm away, causing the needle to come out, and the medication to not be completely administered. The patient was not injured or harmed in any way, but he claimed the vaccine hurt, so he moved his arm by instinct.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received an additional dose more than a year later.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein, Differential white blood cell count, Full blood count, Localised infection, Mobility decreased
Clinical narrative: Developed a "chronic" infection on right arm, unable to mobilize arm and extreme pain.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Developed a "chronic" infection on right arm, unable to mobilize arm and extreme pain.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, FLU3, FLU3, PNC20, PNC20
Symptoms: Loss of consciousness
Clinical narrative: Patient reported to the Pharmacy for 4 vaccines. The Flu and the Covid vaccines were administered first: patient reported being fine after this first 2 vaccine. The Prevnar 20  was then administered, patient lost consciousness shortly after receiving the Prevnar shot. She was unconscious for about 10 seconds and EMTs was called to the scene.  Patient's vitals were stable. Patient's husband reported that patient has a history of fainting after vaccines.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Oxygen saturation decreased, Pyrexia, Tachycardia
Clinical narrative: Fever, Chills, Tachycardia, low oxygen levels at rest, and pain at site.
Age: 52.0
Sex: M
Vaccine: PNC21
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated they had a fever the evening of the vaccine and tightness in his arm at site of injection.  The next day arm was considerably swollen and red, warm to the touch.  Two days post injection swelling still increasing and area of redness was spreading.  Patient was prescribed cephalexin 500mg every 6 hours for 10 days with diagnosis of cellulitis.
Age: 52.0
Sex: M
Vaccine: PNC21
Symptoms: Pyrexia
Clinical narrative: Patient stated they had a fever the evening of the vaccine and tightness in his arm at site of injection.  The next day arm was considerably swollen and red, warm to the touch.  Two days post injection swelling still increasing and area of redness was spreading.  Patient was prescribed cephalexin 500mg every 6 hours for 10 days with diagnosis of cellulitis.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine given to patient. No side effect noticed at time of administration. Mother of child contacted and advised of event and need for revaccination.
Age: 79.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue, Feeling abnormal, Myalgia, Pruritus
Clinical narrative: pt says his left arm started to itch. The itching moved down his left arm down to his hand. He started itching on his neck, he was tired, he had chills, fever, developed hives on his back, both arms, legs, ankles and pelvic area. His muscles were achy and sore. He was misrable for 3 to 4 weeks.  He called the pharmacy and was told he should have been given the moderna covid vaccine and not the pfizer vaccine and try taken benadryl. He went to his doctor and was treated with steroids and antibiotics. He was referred to a dermatologist MD.  Both doctors said he had a reaction to the vaccines. He was prescibed cetirizine 10mg and triamcinolone ointments. His hives still come and go. He is some better but not well and it has worsened his COPD symptoms.
Age: 79.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pyrexia, Urticaria
Clinical narrative: pt says his left arm started to itch. The itching moved down his left arm down to his hand. He started itching on his neck, he was tired, he had chills, fever, developed hives on his back, both arms, legs, ankles and pelvic area. His muscles were achy and sore. He was misrable for 3 to 4 weeks.  He called the pharmacy and was told he should have been given the moderna covid vaccine and not the pfizer vaccine and try taken benadryl. He went to his doctor and was treated with steroids and antibiotics. He was referred to a dermatologist MD.  Both doctors said he had a reaction to the vaccines. He was prescibed cetirizine 10mg and triamcinolone ointments. His hives still come and go. He is some better but not well and it has worsened his COPD symptoms.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given expired vaccine. No side effects noticed at time of vaccination. Mother of patient was called and advised of vaccination error and expressed need to revaccinate.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Angiotensin converting enzyme, Anti-transglutaminase antibody, Antinuclear antibody, Antiphospholipid antibodies, Arteriogram carotid
Clinical narrative: sudden onset of chorea preferring left side but NOT hemiballismus, successfully treated with risperidone/lorazepam after 3 day hospital stay
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood copper, Blood creatine phosphokinase, Blood folate, Blood immunoglobulin A, Blood thyroid stimulating hormone
Clinical narrative: sudden onset of chorea preferring left side but NOT hemiballismus, successfully treated with risperidone/lorazepam after 3 day hospital stay
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Ceruloplasmin, Chorea, Complement analysis, Complement factor C3
Clinical narrative: sudden onset of chorea preferring left side but NOT hemiballismus, successfully treated with risperidone/lorazepam after 3 day hospital stay
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Complement factor C4, Computerised tomogram head, Drug screen, Electrophoresis protein, Full blood count
Clinical narrative: sudden onset of chorea preferring left side but NOT hemiballismus, successfully treated with risperidone/lorazepam after 3 day hospital stay
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Metabolic function test, Red blood cell sedimentation rate, Streptococcus test, Ultrasound Doppler
Clinical narrative: sudden onset of chorea preferring left side but NOT hemiballismus, successfully treated with risperidone/lorazepam after 3 day hospital stay
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B12
Clinical narrative: sudden onset of chorea preferring left side but NOT hemiballismus, successfully treated with risperidone/lorazepam after 3 day hospital stay
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Rash papular, Rash pruritic, Streptococcus test negative
Clinical narrative: Itchy, raised, rash first appearing near buttocks, thighs, bottom of forearms, and back of calves in PM of 26Jan2025. OTC Hydrocortisone cream applied to affected areas to limited effect. After 12 hours, spread to lower torso, middle of back, under chin, behind ears, and face. Received script for children's cetirizine and prednisolone following visit to urgent care in AM of 27Jan2025 following symptom presentation which was filled in PM. Administered single dose of cetirizine, but child was unable to tolerate (vomiting) prednisolone as it was a liquid adult formulation and not compounded for child use. Visit to ER in PM of 27Jan2025 suggested delayed reaction to vaccines received on 21Jan2025.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea and vomiting 24 hours after vaccination that lasted for 6 hours
Age: 33.0
Sex: F
Vaccine: RSV, UNK
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Patient is 33 weeks, 0 days pregnant (estimated due date 3/16/25) and received nirsevimab monoclonal antibody instead of Abrysvo for passive protection to fetus. MA administering vaccine was confused with the wording on the CDC immunization schedule that stated "Either maternal RSV vaccination with Abrysvo or infant immunization with nirsevimab (RSV monoclonal antibody) is recommended to prevent severe respiratory syncytial virus disease in infants." It was interpreted that either Abrysvo or nisevimab could be administered to the pregnant patient. At this time no adverse effects noted to the patient or fetus.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Wrong product administered
Clinical narrative: Wrong vaccine given (Moderna covid).  adult dose ordered, and pediatric dose given.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Blood pressure fluctuation, Brain fog, Cardiac monitoring, Cardiac stress test
Clinical narrative: Patient received her Covid 19 booster on August 31, 2024.  On Wednesday, September 4, 2024, she lost sight and fainted at school toward the end of the school day.  She described not being able to think clearly and everything going dark.  I took her to the pediatrician to be checked and no clear diagnosis was made.  She continued to experience extreme dizzy spells brought on my changing positions and sometimes without any trigger.  We saw two cardiologists over the course of several weeks while the symptoms continued.  She is a competitive swimmer and was having symptoms in the water as well. All other causes were ruled out (no infections, no illness, no ear issues, etc.).  Dr was able to determine that she was experiencing positional syncope and her blood pressure was fluctuating as well as her rate. She was diagnosed with autonomic dysfunction with POTS and syncope related to the Covid vaccine.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram, Electrocardiogram, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: Patient received her Covid 19 booster on August 31, 2024.  On Wednesday, September 4, 2024, she lost sight and fainted at school toward the end of the school day.  She described not being able to think clearly and everything going dark.  I took her to the pediatrician to be checked and no clear diagnosis was made.  She continued to experience extreme dizzy spells brought on my changing positions and sometimes without any trigger.  We saw two cardiologists over the course of several weeks while the symptoms continued.  She is a competitive swimmer and was having symptoms in the water as well. All other causes were ruled out (no infections, no illness, no ear issues, etc.).  Dr was able to determine that she was experiencing positional syncope and her blood pressure was fluctuating as well as her rate. She was diagnosed with autonomic dysfunction with POTS and syncope related to the Covid vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Mechanical urticaria, Pruritus, Quality of life decreased, Urticaria
Clinical narrative: I have been SUFFERING from chronic hives, dermagraphia since the vaccine. i was prescribed atarax but it never helped. It's been over 3years. My life has been severely impacted, i no longer live a normal life everyday im itching and breaking out in hives. my life is completely miserable since the covid vaccine
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine given before due
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Fatigue, Headache, Laboratory test abnormal, Loss of personal independence in daily activities
Clinical narrative: Patient had the vaccine on May 23, 2024.  That evening he developed a headache, took Tylenol with no relief.   Headache worsened that night and over the next two days.  Took Tylenol around the clock.  On day  3 his neck became very stiff and painful, unable to rotate it at all.  PCP notified.  Next day both his shoulders when he woke up were stiff and unable to move them.  Severe pain if he tried.  Was unable to get out of bed.  He was like a stiff man.  Next day his hips and knees hurt also.   He was a mess.  Unable to get up out of bed to use toilet without maximum help.   Dr. a rheumatologist was contacted and an appt made for the following week.  After a complete interview and examination he told us patient had Polymyalgia Rheumatica, that was trigged by his body immune system reacting to the  Prevnar vaccine.  Was begun on Prednisone 40 mg and within 2 days he felt much better.  He was slowly tapered down to the present 5 mg and has been unable x 2 tries to reduce further or the initial symptoms return.  The fatigue was unbelievable!  He would lay down and within 2 minutes he would be sound asleep.  The Prednisone had no effect on this fatigue.
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain, Pain, Polymyalgia rheumatica
Clinical narrative: Patient had the vaccine on May 23, 2024.  That evening he developed a headache, took Tylenol with no relief.   Headache worsened that night and over the next two days.  Took Tylenol around the clock.  On day  3 his neck became very stiff and painful, unable to rotate it at all.  PCP notified.  Next day both his shoulders when he woke up were stiff and unable to move them.  Severe pain if he tried.  Was unable to get out of bed.  He was like a stiff man.  Next day his hips and knees hurt also.   He was a mess.  Unable to get up out of bed to use toilet without maximum help.   Dr. a rheumatologist was contacted and an appt made for the following week.  After a complete interview and examination he told us patient had Polymyalgia Rheumatica, that was trigged by his body immune system reacting to the  Prevnar vaccine.  Was begun on Prednisone 40 mg and within 2 days he felt much better.  He was slowly tapered down to the present 5 mg and has been unable x 2 tries to reduce further or the initial symptoms return.  The fatigue was unbelievable!  He would lay down and within 2 minutes he would be sound asleep.  The Prednisone had no effect on this fatigue.
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: Red blood cell sedimentation rate abnormal, Somnolence
Clinical narrative: Patient had the vaccine on May 23, 2024.  That evening he developed a headache, took Tylenol with no relief.   Headache worsened that night and over the next two days.  Took Tylenol around the clock.  On day  3 his neck became very stiff and painful, unable to rotate it at all.  PCP notified.  Next day both his shoulders when he woke up were stiff and unable to move them.  Severe pain if he tried.  Was unable to get out of bed.  He was like a stiff man.  Next day his hips and knees hurt also.   He was a mess.  Unable to get up out of bed to use toilet without maximum help.   Dr. a rheumatologist was contacted and an appt made for the following week.  After a complete interview and examination he told us patient had Polymyalgia Rheumatica, that was trigged by his body immune system reacting to the  Prevnar vaccine.  Was begun on Prednisone 40 mg and within 2 days he felt much better.  He was slowly tapered down to the present 5 mg and has been unable x 2 tries to reduce further or the initial symptoms return.  The fatigue was unbelievable!  He would lay down and within 2 minutes he would be sound asleep.  The Prednisone had no effect on this fatigue.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Cough, Depression, Dizziness
Clinical narrative: Severe fatigue, join pain, abdominal pain, dizziness, mucus, cough, headages, Depression
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Hepatic mass, Imaging procedure abnormal, Secretion discharge
Clinical narrative: Severe fatigue, join pain, abdominal pain, dizziness, mucus, cough, headages, Depression
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness, swelling entire upper arm
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 7.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MENINGOCOCCAL MCV4O (MENVEO) - 1 VIAL given to 7 year old patient. no symptoms reported. no treatment.
Age: 50.0
Sex: F
Vaccine: HPV9, VARZOS
Symptoms: Chills, Fatigue, Headache, Lethargy, Myalgia
Clinical narrative: headache, chills, fever, lethargic/fatigue, muscle aches/pain
Age: 50.0
Sex: F
Vaccine: HPV9, VARZOS
Symptoms: Pyrexia
Clinical narrative: headache, chills, fever, lethargic/fatigue, muscle aches/pain
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Patient stated that she had a headache that would not go away for a week.   She also experienced more fatigue than usual.  She stated that the headache is gone and she does not require follow up medical attention but thought it best to report it.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: Patient was meant to receive pregnancy dose of Tdap and received DTaP instead. No adverse events reported by patient.  Estimated delivery date is 4/9/25.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient received 0.3ml undiluted dose
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Limb mass
Clinical narrative: Child had a knot on left arm and some redness.
Age: 17.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Hypersomnia, Mobility decreased, Nausea, Pain, Pyrexia
Clinical narrative: The evening following vaccination, the patient developed symptoms of fever to 102-103, throat tightness, facial swelling, and body aches.  The mother gave him a dose of Benadryl and he had improvement in swelling.  The mother reports they had a home pulse oximeter and felt like his oxygen level was in the high 80s.  However he did not go to the urgent care or ER for evaluation.  The family is concerned about a possible allergic reaction.   Our triage nurse recorded the following..."Called mom. and she states they had a really bad weekend, flu/Men B. She thinks he had an allergic RXN- had every sx on the handout. High fever , could barley lift his arm- extremely painful- difficulty with PJ's. Saturday slept all day 102.7 fever. Felt tightening in throat and Saturday night had face swelling, fever came down with compresses and alternating Tylenol and Ibuprofen. No antihistamine. Very nauseated. Today no fever, still throat tightness and slightly puffy face. Kept him home today. No diarrhea. Arm is better today. Pulse OX on Saturday read 73-83, felt SOB - book said he was still in the normal range. Pulse OX yesterday was 93% and 97% today. Told mom I think he needs to be seen- placed on hold and relayed the above and he states he should be seen in UC. Recommended that he be seen in UC given the ongoing throat tightness and puffy face- may need steroid/antihistamines- mom asked if she could just give him Benadryl- needs documentation of symptoms- should be seen- mom plans to take to clinic.  Patient states that throat feels tighter then yesterday but is not SOB- can hear him talking and mom said he is breathing thru his nose.  She is asking for letter for school- in case she forgets to ask at UC. "
Age: 17.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Swelling face, Throat tightness
Clinical narrative: The evening following vaccination, the patient developed symptoms of fever to 102-103, throat tightness, facial swelling, and body aches.  The mother gave him a dose of Benadryl and he had improvement in swelling.  The mother reports they had a home pulse oximeter and felt like his oxygen level was in the high 80s.  However he did not go to the urgent care or ER for evaluation.  The family is concerned about a possible allergic reaction.   Our triage nurse recorded the following..."Called mom. and she states they had a really bad weekend, flu/Men B. She thinks he had an allergic RXN- had every sx on the handout. High fever , could barley lift his arm- extremely painful- difficulty with PJ's. Saturday slept all day 102.7 fever. Felt tightening in throat and Saturday night had face swelling, fever came down with compresses and alternating Tylenol and Ibuprofen. No antihistamine. Very nauseated. Today no fever, still throat tightness and slightly puffy face. Kept him home today. No diarrhea. Arm is better today. Pulse OX on Saturday read 73-83, felt SOB - book said he was still in the normal range. Pulse OX yesterday was 93% and 97% today. Told mom I think he needs to be seen- placed on hold and relayed the above and he states he should be seen in UC. Recommended that he be seen in UC given the ongoing throat tightness and puffy face- may need steroid/antihistamines- mom asked if she could just give him Benadryl- needs documentation of symptoms- should be seen- mom plans to take to clinic.  Patient states that throat feels tighter then yesterday but is not SOB- can hear him talking and mom said he is breathing thru his nose.  She is asking for letter for school- in case she forgets to ask at UC. "
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax normal, Head discomfort, Musculoskeletal discomfort, Tinnitus
Clinical narrative: Tinnitus in both ears. Unknown how many days it started after vaccine.  Head and neck pressure that started after that and has never gone away. Had CT chest done in 2024 to look at vasculature that did not show any abnormality.  Still affected by tinnitus and this head/neck pressure.
Age: 50.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Pt was administered 2nd Prevnar20 3 years after receiving first one
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: immunization administered past beyond use date. called manufacture was beyond use 1 day. reviewed with provider ok to readminister 1-2 months mother notified
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: immunization administered past beyond use date. called manufacture was beyond use 1 day. reviewed with provider ok to readminister 1-2 months mother notified
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Chest pain, Cough, Decreased appetite, Fatigue, Feeling of body temperature change
Clinical narrative: SUNDAY NIGHT, THEY GOT VERY TIRED SLEPT FROM 6 TO MONDAY . APPETITE LOSS, CHEST IS IN PAIN WHEN THEY COUGH, HOLE IN HEART HURTS WHEN THEY COUGH, HAVE FLUTUATING TIMES OF BEING TOO COLD, AND BEING TOO HOT. They feel sick, took two tylenols on the 27th, had no effect. patient also says they have headache, since the time they got their vaccine.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Malaise
Clinical narrative: SUNDAY NIGHT, THEY GOT VERY TIRED SLEPT FROM 6 TO MONDAY . APPETITE LOSS, CHEST IS IN PAIN WHEN THEY COUGH, HOLE IN HEART HURTS WHEN THEY COUGH, HAVE FLUTUATING TIMES OF BEING TOO COLD, AND BEING TOO HOT. They feel sick, took two tylenols on the 27th, had no effect. patient also says they have headache, since the time they got their vaccine.
Age: 7.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 7 when he received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10.
Age: 9.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 9 when she received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10.
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: duplicate vaccine
Age: 66.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient received the vaccine on 1/2/25 and notified me of her arm and shoulder hurting on 1/27/25. I told her to try Voltaren gel and a Lidocaine patch. She tried a lidocaine patch and it did help for awhile. She is going to the doctor 1/29/25.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given past the beyond use date of 01/16/25
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse event was reported; HCP called to report a patient received a fourth dose of GARDASIL 9 after completing a 3-dose-series in 2022 ( exact date unknown). No side effects or symptoms reported. No additional information reported. No additional AE/ No PQC.; This spontaneous report was received from physician assistant and refers to a 26-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 23-JAN-2025, the patient was vaccinated withfourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml, lot #Y012864, expiration date: 29-MAY-2026, administered for prophylaxis (strength, and route of administration were not provided) after completing third dose series in unknown date in 2022 (Extra dose administered). No additional adverse event was provided.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects were reported; HCP called to report that a patient had been administered MMR II after the expiration date. Administered 1/21/2025, expired 1/19/2025.; This spontaneous report has been received from a nurse regarding a 5-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 21-JAN-2025 (also reported as 24-JAN-2025), the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, administered for prophylaxis, (lot number reported as X002058, expiration date reported and validated as 19-JAN-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not provided) (Expired product administered).  No adverse side effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HBP calling on behalf of Physician with a report of an adverse event regarding an expired dose of PROQUAD that was inadvertently administered to a patient.   HBP stated that the PROQUAD had a labeled expiration date of 1/5/2025 and was administered o; This spontaneous report was received from a Health business professional and refers to a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.  On 17-JAN-2025, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA[recombinant human albumin]) (PROQUAD) injection, 0.5 milliliter, administered as prophylaxis (Lot No. X018584 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and upon internal validation established as 05-JAN-2025) (strength, dose number, route of administration, anatomical location of administration and vaccination scheme frequency were not provided)(expired product administered).  No additional adverse event was reported (no adverse event)
Age: 0.17
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no side effects or symptoms have been reported; HCP called to report a dose of VARIVAX was administered to a 2-month-old patient. no side effects or symptoms have been reported. No Additional information provided. No AE/PQC.; This spontaneous report was received from a medical assistant and refers to a 2-month-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 08-NOV-2024 the 2-month-old patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # Y011712 and expiration date 02-JUL-2026, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (product administered to patient of inappropriate age). No side effects or symptoms have been reported (o adverse event).
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Areflexia, Dysphagia, Gait inability, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Guillain Barre syndrome; This serious case was reported by a consumer via sales rep and described the occurrence of guillain barre syndrome in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number X4EA5, expiry date 16-OCT-2025) for prophylaxis.   On 19-DEC-2024, the patient received the 1st dose of Arexvy. On 30-DEC-2024, 11 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant). The patient was treated with immunoglobulins. The outcome of the guillain barre syndrome was not resolved.   The reporter considered the guillain barre syndrome to be related to Arexvy.     The company considered the guillain barre syndrome to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 13-JAN-2025 The patient was in hospital for Guillain Barre syndrome and Guillain Barre syndrome was reported as worsened.  Patient was vaccinated with Arexvy and went to emergency room on 31st December 2024. The patient had completed 5 treatments of IVIG and still in hospital. Patient was unable to walk and had no feeling/reflexes in legs, unable to move right arm/hand and could not feed herself and on thickened liquids due to swallowing issues.; Sender's Comments: Guillain-Barre syndrome  is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Immunoglobulin therapy, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Guillain Barre syndrome; This serious case was reported by a consumer via sales rep and described the occurrence of guillain barre syndrome in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number X4EA5, expiry date 16-OCT-2025) for prophylaxis.   On 19-DEC-2024, the patient received the 1st dose of Arexvy. On 30-DEC-2024, 11 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant). The patient was treated with immunoglobulins. The outcome of the guillain barre syndrome was not resolved.   The reporter considered the guillain barre syndrome to be related to Arexvy.     The company considered the guillain barre syndrome to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 13-JAN-2025 The patient was in hospital for Guillain Barre syndrome and Guillain Barre syndrome was reported as worsened.  Patient was vaccinated with Arexvy and went to emergency room on 31st December 2024. The patient had completed 5 treatments of IVIG and still in hospital. Patient was unable to walk and had no feeling/reflexes in legs, unable to move right arm/hand and could not feed herself and on thickened liquids due to swallowing issues.; Sender's Comments: Guillain-Barre syndrome  is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have the shingles). The patient was treated with lidocaine. The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JAN-2025 and 21-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the shingles, the patient had received shots of shingles vaccine. Thankful mild case but the pain was horrible, the reporter could not take pain medication. The patient was using lidocaine cream. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description,  time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles/ very painful and itchy; 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: Got shingles/ very painful and itchy). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine 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: 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient got the shot and the booster of shingles vaccine.  The patient got shingles and had it for 10 days so far.  The patient reported it to be very painful and itchy. This case was considered as suspected vaccination failure as details regarding, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available; 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 1 and Shingles vaccine 2.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I got SHINGLES anyways; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chemotherapy (User was going through chemotherapy when they contracted shingles.).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got SHINGLES anyways). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   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: 18-JAN-2025 Reporter commented that they got the shingles vaccine but got shingles anyway.  Reporter was went through chemotherapy when they contracted shingles. Reporter got a SHINGLES vaccine. It was TWO shots. Reporter got SHINGLES anyways because of the chemo BUT it was mild. No big deal from what he/she heard it was painful. Pharmacist said it was minor because he/she Did had the SHINGLES vaccine.  Would had been way worse.  So he/she was grateful. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix dose 1 and Shingrix dose 2.
Sex: F
Vaccine: FLU3
Symptoms: Cutaneous vasculitis, Erythema
Clinical narrative: suspected leukocytoclastic vasculitis; red spots on legs; This serious case was reported by a consumer via call center representative and described the occurrence of leukocytoclastic vasculitis in a female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number T74KG) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, 7 days after receiving Fluarix 2024-2025 season, the patient experienced leukocytoclastic vasculitis (Verbatim: suspected leukocytoclastic vasculitis) (serious criteria GSK medically significant) and red spotty rash (Verbatim: red spots on legs). The outcome of the leukocytoclastic vasculitis was not reported and the outcome of the red spotty rash was unknown.   It was unknown if the reporter considered the leukocytoclastic vasculitis and red spotty rash to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the leukocytoclastic vasculitis to be unrelated to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the red spotty rash to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-JAN-2025 Reporter was the patient's father. Patient developed red spots on the legs 7 days after receiving the Fluarix vaccine. Reporter suspected that the patient developed Leukocytoclastic vasculitis (LCV).; Sender's Comments: Cutaneous vasculitis is an unlisted event which is considered unrelated to GSK vaccine Fluarix 2024-2025 season and Fluarix PRE-FILLED SYRINGE DEVICE.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Gout, Hypoaesthesia, Pain in extremity, Vein disorder
Clinical narrative: treated for gout; my leg still wobble, numb and hurts; my leg still wobble, numb and hurts; vein replacement; instant leg pain; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 12Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL taken for atrial fibrillation; LISINOPRIL taken for atrial fibrillation; XARELTO taken for atrial fibrillation. Vaccination history included: bnt162b2 (dose 1, single; left arm), administration date: 22Dec2020, when the patient was 65-year-old, for covid-19 immunization; bnt162b2 (dose 2, single; intramuscular; left arm), administration date: 11Jan2021, when the patient was 65-year-old, for covid-19 immunization, reaction(s): "CHF", "taste/ want my taste back", "grinding teeth", "interrupting sleep", "nauseating", "kidney damage", "wobble right leg"; bnt162b2 (dose 3 (booster), single; left arm), administration date: 11Dec2021, when the patient was 66-year-old, for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2022, outcome "unknown", described as "instant leg pain"; VEIN DISORDER (medically significant) with onset Feb2023, outcome "unknown", described as "vein replacement"; GOUT (non-serious), outcome "unknown", described as "treated for gout"; HYPOAESTHESIA (non-serious), GAIT DISTURBANCE (non-serious), outcome "unknown" and all described as "my leg still wobble, numb and hurts". The events "vein replacement", "instant leg pain", "treated for gout" and "my leg still wobble, numb and hurts" required physician office visit. Therapeutic measures were taken as a result of vein disorder, pain in extremity, gout, hypoaesthesia, gait disturbance. Clinical course: In Dec2022, the patient had instant leg pain. Treated for gout. In Feb2023, vein replacement, felt ok, but neurologist still cannot figure out why leg still wobble, numb, and hurt.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400163246 same patient, different dose/AE;
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Slight Headache; This is a spontaneous report received from a Consumer or other non HCP from License Party.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), since 01Aug2024 (ongoing)) at 300 mg weekly, subcutaneous for asthma. The patient's relevant medical history was not reported. Concomitant medication(s) included: CARVEDILOL; BUDESONIDE; BREO ELLIPTA; VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]; SPIRIVA; MAGNESIUM OXIDE; VITAMIN D [COLECALCIFEROL]; CALCIUM CARBONATE. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Slight Headache". The action taken for dupilumab was dosage not changed.  Additional information: It was reported that, "the patient asking if okay to inject Dupixent the day after her Covid vaccine. I advised no issue. The patient has a slight headache after getting vaccine.  Batch/lot number is not provided, and it cannot be obtained.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP wanted to know if patient started vaccination series at 14 years of age, if they come in at 15, what is recommended for the series.; No additional AE; This spontaneous report was received from a pharmacist and refers to a 15-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 an unknown date (also reported as at 14 years of age), the patient started vaccination series with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  Healthcare professional (HCP) wanted to know if patient come in at 15, what was recommended for the vaccination series (Inappropriate schedule of product administration). No additional adverse event was reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Nurse calling to report inadvertently administering an expired dose of PNEUMOVAX 23. vaccine expired on 11/22/2024 and was administered on 1/22/2025.; This spontaneous report was received from a Licensed Practical Nurse regarding a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.  On 22-JAN-2025, the patient was inadvertently vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, prefilled syringe, administered for prophylaxis (lot number X014729 has been verified to be a valid number for pneumococcal 23v polysaccharide vaccine [PNEUMOVAX23], expiration date 22-NOV-2024; dose, anatomical site of injection and route of administration were not provided) (Expired product administered). It was reported that the product did not underwent temperature excursion. No additional information or adverse event was reported for the patient.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/No symptoms reported; HCP calling regarding GARDASIL-9 dosing schedule for a 13 year old female patient. Caller stated that the third dose was administered a "little after" 6 months.; This spontaneous report was received from a consumer and refers to a 13-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 an unknown date and on an unknown date in 2024, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), respectively. On 21-JAN-2025, the patient was vaccinated with the third dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W026152, expiration date: 29-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). Reporter stated that this third dose was administered a "little after" 6 months (Inappropriate schedule of product administration). No symptoms reported. No further information was provided.   Lot # is being requested and will be submitted if received.