chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abnormal menstrual clots, Blood ethanol, Blood follicle stimulating hormone normal, Blood iron, Blood magnesium
Clinical narrative: o The evening of the first dose I experienced extreme cramping, excessive bleeding and blood clots being passed that was not consistent with a typical period. I passed out due to pain and the bleeding did subside within 24 hours. I stopped having nomal periods and was diagnosed with premature ovarian failure by December 2022. The day after this dose I was admitted to the emergency room with  extreme fatigue, vertigo, tinnitus and brain fog. I went to the ER due to not being able to stand. I was given a CT Scan, Chest Xray, CBC w/Auto Differential bloodwork, protime-inr bloodwork, CBC and Differential bloodwork, MR Brain WWO Contrast, Ethanol level blood test, magnesium level blood test, troponin blood test, metabo
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood prolactin normal, Blood thyroid stimulating hormone, Brain fog, Chest X-ray, Computerised tomogram
Clinical narrative: o The evening of the first dose I experienced extreme cramping, excessive bleeding and blood clots being passed that was not consistent with a typical period. I passed out due to pain and the bleeding did subside within 24 hours. I stopped having nomal periods and was diagnosed with premature ovarian failure by December 2022. The day after this dose I was admitted to the emergency room with  extreme fatigue, vertigo, tinnitus and brain fog. I went to the ER due to not being able to stand. I was given a CT Scan, Chest Xray, CBC w/Auto Differential bloodwork, protime-inr bloodwork, CBC and Differential bloodwork, MR Brain WWO Contrast, Ethanol level blood test, magnesium level blood test, troponin blood test, metabo
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cortisol normal, Differential white blood cell count, Dysmenorrhoea, Dysstasia, Fatigue
Clinical narrative: o The evening of the first dose I experienced extreme cramping, excessive bleeding and blood clots being passed that was not consistent with a typical period. I passed out due to pain and the bleeding did subside within 24 hours. I stopped having nomal periods and was diagnosed with premature ovarian failure by December 2022. The day after this dose I was admitted to the emergency room with  extreme fatigue, vertigo, tinnitus and brain fog. I went to the ER due to not being able to stand. I was given a CT Scan, Chest Xray, CBC w/Auto Differential bloodwork, protime-inr bloodwork, CBC and Differential bloodwork, MR Brain WWO Contrast, Ethanol level blood test, magnesium level blood test, troponin blood test, metabo
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Full blood count, Haemoglobin normal, International normalised ratio, Magnetic resonance imaging head, Menstrual disorder
Clinical narrative: o The evening of the first dose I experienced extreme cramping, excessive bleeding and blood clots being passed that was not consistent with a typical period. I passed out due to pain and the bleeding did subside within 24 hours. I stopped having nomal periods and was diagnosed with premature ovarian failure by December 2022. The day after this dose I was admitted to the emergency room with  extreme fatigue, vertigo, tinnitus and brain fog. I went to the ER due to not being able to stand. I was given a CT Scan, Chest Xray, CBC w/Auto Differential bloodwork, protime-inr bloodwork, CBC and Differential bloodwork, MR Brain WWO Contrast, Ethanol level blood test, magnesium level blood test, troponin blood test, metabo
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Metabolic function test, Oestradiol normal, Premature menopause, Scan with contrast, Thyroxine free normal
Clinical narrative: o The evening of the first dose I experienced extreme cramping, excessive bleeding and blood clots being passed that was not consistent with a typical period. I passed out due to pain and the bleeding did subside within 24 hours. I stopped having nomal periods and was diagnosed with premature ovarian failure by December 2022. The day after this dose I was admitted to the emergency room with  extreme fatigue, vertigo, tinnitus and brain fog. I went to the ER due to not being able to stand. I was given a CT Scan, Chest Xray, CBC w/Auto Differential bloodwork, protime-inr bloodwork, CBC and Differential bloodwork, MR Brain WWO Contrast, Ethanol level blood test, magnesium level blood test, troponin blood test, metabo
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tinnitus, Troponin, Vertigo, Vitamin B12 normal
Clinical narrative: o The evening of the first dose I experienced extreme cramping, excessive bleeding and blood clots being passed that was not consistent with a typical period. I passed out due to pain and the bleeding did subside within 24 hours. I stopped having nomal periods and was diagnosed with premature ovarian failure by December 2022. The day after this dose I was admitted to the emergency room with  extreme fatigue, vertigo, tinnitus and brain fog. I went to the ER due to not being able to stand. I was given a CT Scan, Chest Xray, CBC w/Auto Differential bloodwork, protime-inr bloodwork, CBC and Differential bloodwork, MR Brain WWO Contrast, Ethanol level blood test, magnesium level blood test, troponin blood test, metabo
Age: 57.0
Sex: M
Vaccine: HEPAB
Symptoms: Wrong product administered
Clinical narrative: Pt was accidently given Twinrix vaccination instead of shingrix vaccine. Pt already had immunity to Hep B confirmed from 2/15/24 blood draw. MD was notified. No medical issues occurred due to the vaccination.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Client was given a vaccine that he was due to receive until 6-26/2025
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cognitive disorder, Impaired work ability, Neuropsychological test abnormal
Clinical narrative: pt with continuing cognitive decline, unable to work due to cognitive changes since the vaccine, increasing anxiety
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient received the vaccine in the left deltoid on 5/31/24. The patient then presented to urgent care on Monday 6/3/24, stating after a few hours after the vaccine was administered, the area started to swell, was sore, hot and red as well. The patient stated she applied ice to the area, but did not relieve symptoms. When presenting to urgent care, she stated the same and the provider observed this as well. She was prescribed antibiotics for one week to help these symptoms. There were no further complaints from the patients following this.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: The patient's caretaker stated the patient's blood sugar was 150 in the morning. The patient had a bowl of cereal and came in to get a shingles vaccine as well as a PCV20 shortly after. Pt's caretaker called an hour after asking if elevated blood sugars are a common side effect of vaccines in diabetics. The patient had a reading of 270. Pt states this happens often. I advised them to seek urgent medical care or contact the Doctor after taking a second elevated reading.
Age: 46.0
Sex: M
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Pt was given Prevnar 20 instead of the ordered pneumococcal 23. MD was notified. Pharmacy was notified. Pt had no medical complication from the medication error.
Age: 0.33
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: child was given tdap instead of dtap, no adverse symptoms
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Feeling abnormal, Laboratory test normal, Paraesthesia
Clinical narrative: 7/30/24 patient claims his blood pressure became elevated, tingling in left arm, not feeling good.  7/31/24 patient went to the er. dr ran multiple cardiac/blood clot related tests and results were negative. Pt then talked to his primary  and she thought it might be related to the vaccine.  8/1/24 he is feeling better
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Ear pain, Hyperventilation, Pallor, Paraesthesia
Clinical narrative: 1:15 pm.  Patient received all three vaccines. Patient was accompanied by his grandmother. Grandmother reports walking to parking lot with patient and immediately complained tingling to arms, legs and pain in bilateral ears. Grandmother and patient returned to clinic. Patient was hyperventilating and skin was pale in color, dry. Patient was placed in supine position. Encouraged slower breathing. Ice pack placed to back of neck, water given. O2 sats 100%, Continued to monitor patient for 45 minutes for any further symptoms.  Patient recovered, stable, color of skin returned.  Nurse assisted patient to vehicle in wheelchair per protocol.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site nodule, Injection site warmth
Clinical narrative: Patient was administered the vaccines on 7/30/24- no immediate reactions occurred. Mother contacted the Health Department and spoke with the RN concerning inflammation around the site on 7/31/24. She stated "the site is red and warm around where the vaccine has been given about 1-1.5 inches around the site". RN informed mother that there is normal inflammation around the vaccine site after administration and at the time did not seem to be an adverse reaction. Encouraged mother to apply cold compress, make a mark around the site and monitor for any worsening. On 8/1/24, mother called the Health Department again and stated the site had worsened and was now inflamed where both vaccines had been given. She states "the area is red, warm and feels like a knot where the vaccine was given and it is red around her entire arm". Mother contacted the Pediatrician who informed the mother she needed to take the child to the ER.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient started feeling dizzy, lightheaded and started sweating a few minutes after receiving vaccine. Vitals taken and determined by provider that they were within normal limits. Patient was given candy and water and observed for 20 minutes in the room. After 20 minutes patient reported symptoms resolved and was checked out.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Patient was administered 2 vaccines on 7/30/24- no adverse reactions occurred. Mother contacted the health department on 8/1/24 and stated he was experiencing inflammation around the site where the Kinrix was administered- mother described the site as red, about 5-6 inches in diameter, warm to the touch and raised. She denies any fever or issues with movement of the arm. She contacted the Pediatrician and was encouraged to go to the ER due to possible reaction.
Age: 25.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: employee states she received first vaccine hepislav b 03/20/2024  lot number 943193 in R deltoid with no adverse reactions and doesn't believe she was pregnant at the time. She received her second dose on 05/17/24 with same lot number and ndc number and two days later experienced a miscarriage. She did mark on her vaccine consent that she was pregnant and states she asked the nurse if this was ok to have. she was provided with education, and informed that she could consult her physician and she provided a list that stated what vaccines she was to avoid, but we did not retain a copy of said list.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: About three minutes after receiving Bexseo vaccine. Pt became hot and lightheaded while sitting in a chair. Her mother alerted us to her abnormal feeling. Pt then proceeded to have a witnessed vasovagal syncope episode. She was breathing normal but unresponsive for less than 20 seconds. She was pale and slightly diaphoretic. She did urinate herself. She then became responsive and was easily transferred to the exam table. She rested while drinking water and eating pretzels for 15 minutes. She returned to normal after a few minutes. She had no residual issues and felt fine. I explained vasovagal syncope to mother and patient. I encouraged increased fluid intake throughout the day. She left the clinic in stable condition in the care of her mother to go home and rest. They will monitor her closely and call with any recurrent or new symptoms.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urinary incontinence
Clinical narrative: About three minutes after receiving Bexseo vaccine. Pt became hot and lightheaded while sitting in a chair. Her mother alerted us to her abnormal feeling. Pt then proceeded to have a witnessed vasovagal syncope episode. She was breathing normal but unresponsive for less than 20 seconds. She was pale and slightly diaphoretic. She did urinate herself. She then became responsive and was easily transferred to the exam table. She rested while drinking water and eating pretzels for 15 minutes. She returned to normal after a few minutes. She had no residual issues and felt fine. I explained vasovagal syncope to mother and patient. I encouraged increased fluid intake throughout the day. She left the clinic in stable condition in the care of her mother to go home and rest. They will monitor her closely and call with any recurrent or new symptoms.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMRV, MNQ, TDAP
Symptoms: Hyperhidrosis, Nausea, Pallor
Clinical narrative: I administered 5 separate immunizations and 1 combination vaccine to this patient. After the first 3 immunizations, I asked the patient if he was okay. The patient confirmed that he felt okay. I waited approximately 1 minute and then I administered the last 3 injections. Shortly afterwards the patient said he was nauseated and he appeared pale. I had the patient put his head between his legs, I had my hand on his back and I could feel that he was sweating. The patient's vital signs were taken and they were within normal limits. Approximately 10 minutes later the patient said that he felt better, and the patient's color had returned. The patient was monitored for another 20 minutes and his vitals signs were taken and were within normal limits. The patient was released in the care of his mother.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Hypotonia, Respiration abnormal, Seizure
Clinical narrative: 10:00 am, approximately 2 minutes after receiving vaccine, patient was walked to the lab for  planned blood draw.  Patient placed in the phlebotomy chair, and the chair arm was lowered securing the patient in the chair.  I asked patient if she was doing okay, she responded verbally "yeah".  At this time patient was left with the phlebotomist.  3-4 minutes later the patients mother ran by the nurses station screaming "She's having a seizure, She's having a seizure to that vaccine - I knew, I knew I shouldn't have done it.  HELP HER"  I responded to the lab with provider, patient was unconscious, had drawn up her arms, slumped over the arm of the chair and had abnormal breathing pattern.   Attempted sternum rub to rouse patient, but was unable to access her chest.  Multiple ice packs applied to patient, who regained consciousness approximately 40 seconds after episode began.  Patient was oriented and aware, pupils PERRLA, blood pressure 100/60 and pulse 54.  Patient was monitored for approximately 15 minutes and escorted to private vehicle via wheelchair and nurse.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right arm Deltoid swelling , redness Ht 155cm  Wt 140cm  Received vaccine 7/30/2024 in office.  Erythematous, pain, and severe edema to right upper extremity.injection, dexamethosone sodium phosphate, 12 mg   Warm compression rotating with cold, elevate extremity as much as possible.  Benadryl 50mg every 6 hours until improvement in reaction.      Prescriptions:  cephALEXin 500 mg oral capsule [take 1 capsule (500 mg) by oral route BID x 7 days], #14 (fourteen) capsules,
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP, HIBV, PNC20, PNC20, RV5, RV5
Symptoms: Diarrhoea, Haematuria, Irritability
Clinical narrative: 4/25/24: Received 4 month vaccines (Pediarix, HIB, Prenvar 20 & Rotateq) 4/26/24: Around 2 pm Mom noticed blood in urine (pink tinge in diaper). Fussiness and fatigued noted from Mom.  4/27/24: UA (moderate leukocytes) & Culture (positive for Enterococcus Faecalis) this was a bagged specimen. They couldn't get a hold of Mom so pt never got tx.    5/5/24: Family was out of town and found out about results from 4/27/24. Was seen in ED and had repeat urine (cathed)             - UA showed small blood             - UA Culture was clear    Symptoms resolved.      7/30/24: Received 6 month vaccines (Pediarix, Prevnar 20 & Rotateq) around 4 pm  7/31/24: 4-5 pm Mom noted blood in urine again (pink tinged). Had 3 diapers total like this            - some diarrhea and fussiness but per Mom this is normal for him after vaccines  8/1/24: No blood noted today, pt is acting WNL (eating well, playful, etc).             - Mom states lips/mouth moist, good wet diapers, etc. Denies fevers
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Autonomic nervous system imbalance, Computerised tomogram head, Detoxification
Clinical narrative: JANSSEN #1 3/30/2021 DEVELOPED VACCINE SMALL FIBER NEUROPATHY, AUTONOMIC DYSFUNCTION, ANA POSITIVE SPECKLED PATTERN, SCL 70 POSITIVE, TREATED WITH HYDROXYCHOROQUINE, 90 DAY COURSE IVERMECTIN, NICOTINE PATCH, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Laboratory test, Magnetic resonance imaging head, Nerve conduction studies
Clinical narrative: JANSSEN #1 3/30/2021 DEVELOPED VACCINE SMALL FIBER NEUROPATHY, AUTONOMIC DYSFUNCTION, ANA POSITIVE SPECKLED PATTERN, SCL 70 POSITIVE, TREATED WITH HYDROXYCHOROQUINE, 90 DAY COURSE IVERMECTIN, NICOTINE PATCH, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test, Small fibre neuropathy
Clinical narrative: JANSSEN #1 3/30/2021 DEVELOPED VACCINE SMALL FIBER NEUROPATHY, AUTONOMIC DYSFUNCTION, ANA POSITIVE SPECKLED PATTERN, SCL 70 POSITIVE, TREATED WITH HYDROXYCHOROQUINE, 90 DAY COURSE IVERMECTIN, NICOTINE PATCH, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 17.0
Sex: M
Vaccine: HEP, HPV9, IPV, MMR, TD, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd series vaccines administered too early. vaccine record documented that 1st series were administered 7/2/2024 when the 1st series was actually administered on 7/20/2024 therefor 2nd series vaccines ( Hep B, HPV, MMR, Polio, Tdap, Varicella) where not actually due when administered.  Patient had no adverse effects or side effects.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report a TE with MMR II.  Administered after being improperly stored. No adverse effects were reported.  No additional AE/No PQC.; HCP called to report a TE with MMR II.  Administered after being improperly stored. No adverse effects were reported.  No additional AE/No PQC.; This spontaneous report was received from 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 27-JUN-2024, the patient was vaccinated with an improperly stored (LLT: improper storage of product in use) dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 ml, lot # w030848, expiration date: 27-SEP-2024, albumin status has been verified as recombinant human albumin (rHA), administered for prophylaxis (route of administration and anatomical location were not provided). No adverse event was reported.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: HPV again; indication: HPV; This spontaneous report was received from a female patient (unknown age) referring to herself.  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 in 2007 (reported as 17 years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection series, administered for papilloma viral infection (HPV) (strength, dose, route, lot #, and expiration date were not provided) (Product use in unapproved indication).  On an unknown date, the patient experienced HPV again (Papilloma viral infection). The patient stated that she found out she had HPV again and wanted to know if she could get revaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). She was referred to her health care professional (HCP). No further information was provided. It was unknown if a treatment was given. At the time of reporting, the outcome of the event HPV again was not known.  The causal relationship between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: no ae; which prompted them to give another dose of GARDASIL-9 on 26-JUL-2024; then the 3rd early dose was given 17-JUN-2024; This spontaneous report was received from medical assistant and refers to a male 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 29-JAN-2024, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1st dose, 0.5 milliliter, once, lot #1965035 was valid for formulation pre-filled syringe, expiration date: 20-SEP-2025, route of administration and anatomical location were not provided) for prophylaxis. On 25-MAR-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (2nd dose, 0.5 milliliter, once, lot #1965035 was valid for formulation pre-filled syringe, expiration date: 20-SEP-2025, route of administration and anatomical location were not provided) for prophylaxis. On 17-JUN-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (3rd dose, 0.5 milliliter, once, lot #1965035 was valid for formulation pre-filled syringe, expiration date: 20-SEP-2025, route of administration and anatomical location were not provided) for prophylaxis, but it was administered earlier than the recommended minimum interval (Inappropriate schedule of vaccine administered). On 26-JUL-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (4th dose, 0.5 milliliter, once, lot #1965035 was valid for formulation pre-filled syringe, expiration date: 20-SEP-2025, route of administration and anatomical location were not provided) for prophylaxis (Extra dose administered). Confirmed no symptomatic adverse events reported. No additional AE/PQC (No adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: An additional dose was administered to a patient after a TE; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age, gender, and race. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 17-JUN-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot number X019625, verified as valid, expiration date reported and upon internal review established as 23-APR-2025 (strength, dose description, and route of administration were not reported) for prophylaxis after a temperature excursion (product storage error).    The temperature excursion was of 51 Fahrenheit degrees, for 446 hours. No PQC was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2407USA010431: US-009507513-2407USA016016: US-009507513-2407USA010455: US-009507513-2407USA015997: US-009507513-2407USA015998: US-009507513-2407USA016011:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: An additional dose was administered to a patient after a TE.; This spontaneous report was received from Other Health Professional (Medical Assistant) and refers to a patient of an unknown age and gender.   The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not reported.  On 14-JUN-2023, the vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection experienced a temperature excursion of 51 degrees Fahrenheit (F) for 446 hours.  On 18-JUN-2024, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, strength, frequency, anatomical injection site and route of administration were not provided; lot #X019625 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported and established as 23-APR-2025) (product storage error).  This is one of multiple reports received from the same reporter. ; Sender's Comments:  US-009507513-2407USA010431: US-009507513-2407USA016016: US-009507513-2407USA010455: US-009507513-2407USA015997: US-009507513-2407USA015998: US-009507513-2407USA016011:
Sex: U
Vaccine: COVID19, PPV
Symptoms: Blindness unilateral
Clinical narrative: Blind my right eye; This spontaneous report was received from a patient of unknown age and gender, referring to his/herself. The patient's historical drugs included amoxicillin, diclofenac, cortisone and retinol. The patient's concurrent conditions included allergy to amoxicillin, diclofenac, cortisone and retinol, and allergy to peaches, asthma, "thyroid", glaucoma, arthritis and illusion (reported as "each time I took that shot (unspecified) and came home, I had a psychedelic effect"). Concomitant therapies included cyanocobalamin(B12) and unspecified "allergy pill".     In April 2021, the patient was vaccinated with an unspecified COVID-19 vaccine dose 1, single in upper R/L arm-shoulder, intramuscularly (strength, dose, Lot #, expiration date and indication were not reported). On 15-DEC-2021, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine(PNEUMOVAX23) dose 1 in the upper arm/shoulder for prophylaxis (strength, dose, route of administration, Lot # and expiration date were not reported). Finally, on 27-AUG-2022, the patient was vaccinated with dose 2 of pneumococcal 23v polysaccharide vaccine(PNEUMOVAX23)  for prophylaxis (strength, dose, route of administration, anatomical location, Lot # and expiration date were not reported). It was stated that the vaccinations occurred at clinic and pharmacy/drug store.    On approximately 27-SEP-2022, the patient experienced "blind in my right eye" (blindness unilateral). No treatment was given to the patient. The outcome of the event was reported as not  resolved.  The causality assessment between the event and the suspect vaccines was not provided.  The reporter considered blindness unilateral to be a disability event.   Upon internal review, blindness unilateral was determined to be a medically significant event.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered second dose of Bexsero about 16 days after the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ZH7SN, expiry date 31-JAN-2027) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: administered second dose of Bexsero about 16 days after the first dose). The outcome of the drug dose administration interval too short was not reported.   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: 22-JUL-2024 Pharmacist stated a 17 year old male patient was administered second dose of Bexsero about 16 days after the first dose. The pharmacist did not know the exact dates of administration. The patient received 2nd dose of Bexsero, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Age: 1.33
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: DTaP vaccine (Boostrix) instead of a Tdap vaccine; DTaP vaccine (Boostrix) instead of a Tdap vaccine. HCP reports the vaccine was administered in the left thigh.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TD2FD, expiry date 31-MAY-2026) for prophylaxis.   On 22-JUL-2024, the patient received Boostrix (intramuscular, left thigh). On 22-JUL-2024, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: DTaP vaccine (Boostrix) instead of a Tdap vaccine) and inappropriate age at vaccine administration (Verbatim: DTaP vaccine (Boostrix) instead of a Tdap vaccine. HCP reports the vaccine was administered in the left thigh.). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   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: 22-JUL-2024 The pediatric patient received a (Boostrix) instead of a DTaP vaccine, which led inappropriate age at vaccine administration and wrong vaccine administered.
Age: 27.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received late; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 27-year-old female patient who received HAB (Twinrix) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On 19-JUL-2024, the patient received the 2nd dose of Twinrix. On 19-JUL-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received late). The outcome of the drug dose administration interval too long was not reported.   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: 22-JUL-2024 Nurse reported a 27 year old female patient received the first dose of Twinrix series on 06 June 2024 and the second dose was given on 19 July 2024. Both doses were administered from lot number H7RF2 (expiration date 17 January 2026). The patient had not yet received third dose. The patient received 2nd dose of Bexsero, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient was only given the reconstitution dilutant and not the actual medication mixed; patient was only given the reconstitution dilutant and not the actual medication mixed; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-JUL-2024, the patient received Shingrix. On 19-JUL-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was only given the reconstitution dilutant and not the actual medication mixed) and inappropriate dose of vaccine administered (Verbatim: patient was only given the reconstitution dilutant and not the actual medication mixed). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-JUL-2024 The nurse reported instead of giving the Shingrix vaccine the patient was only given the reconstitution diluent and not the actual medication mixed, and given the diluent by error, which led inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Shingrix - Administration of a third dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number L995Y, expiry date 15-MAY-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On 22-JUL-2024, the patient received the 3rd dose of Shingrix. On 22-JUL-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Shingrix - Administration of a third dose.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 22-JUL-2024 The reporter reported that there was administration of a third dose of Shingrix to a patient, which led to extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: patient in their 40's received Havrix Pediatric dose; patient in their 40's received Havrix Pediatric dose; This non-serious case was reported by a other health professional via sales rep and described the occurrence of underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   In JUL-2024, the patient received Havrix pediatric. In JUL-2024, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: patient in their 40's received Havrix Pediatric dose) and adult use of a child product (Verbatim: patient in their 40's received Havrix Pediatric dose). The outcome of the underdose was unknown and the outcome of the adult use of a child product was not reported.   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: 23-JUL-2024 The patient was in his/her 40's who received Havrix pediatric dose about one week ago (from the reporting date), which led to underdose and adult use of a child product.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Blood urine present, Haematuria
Clinical narrative: Blood in the Urine /  hematuria; This non-serious case was reported by a nurse via call center representative and described the occurrence of hematuria in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ZH7SN, expiry date 31-JAN-2027) for prophylaxis.   On 18-JUL-2024, the patient received the 2nd dose of Bexsero (left arm). On 21-JUL-2024, 3 days after receiving Bexsero, the patient experienced hematuria (Verbatim: Blood in the Urine /  hematuria). The outcome of the hematuria was not resolved.   It was unknown if the reporter considered the hematuria to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the hematuria to be related to Bexsero and Bexsero 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: 23-JUL-2024 Reporter was a LPN who called from a physician's office. The reporter stated that a patient received second dose suspect vaccine series on 18 July 2024 in his left arm and had hematuria that began on 21 July 2024 and had not resolved.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose on 05 May 2005 and 3rd dose on 07 july 2005; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (on 31th March 2005 received 1st dose). Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On 07-JUL-2005, the patient received the 3rd dose of Engerix B. On 07-JUL-2005, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: received 2nd dose on 05 May 2005 and 3rd dose on 07 july 2005). The outcome of the drug dose administration interval too short was unknown.   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: 23-JUL-2024 A pharmacist reported to verify if the doses of Engerix B that a patient received long time ago were valid.  Patient received Engerix B 1st dose on 31 March 2005, 2nd dose on 05 May 2005 and 3rd dose on 07 July 2005. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Engerix B shorter than the recommended interval, which led to shortening of the vaccine schedule.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, HIBV, MNQ, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Hib (Hiberix) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis.   On an unknown date, the patient received Menveo, Havrix, Pediarix, Kinrix, Boostrix, Infanrix, Engerix B, Hiberix and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Menveo, Havrix, Pediarix, Kinrix, Boostrix, Infanrix, Engerix B, Hiberix and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug was not reported.   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: 23-JUL-2024 Registered Nurse requested stability data for Menveo (1-vial), Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B, Hiberix, Rotarix (liquid) stored at 34.9F by 1hr 7 secs and on 17th June 2024 excursion at 48.7F by 15mins 16 secs. Unknown number of patient administered vaccines after 17th June 2024 excursion and unknown vaccines used since 17th June 2024 excursion which led to incorrect storage of drug.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received Engerix-B pediatric; Adult patient received Engerix-B pediatric; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 50-year-old female patient who received HBV (Engerix B pediatric) (batch number FP9TJ, expiry date 24-MAR-2025) for prophylaxis.   On 19-JUL-2024, the patient received Engerix B pediatric. On 19-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Adult patient received Engerix-B pediatric) and underdose (Verbatim: Adult patient received Engerix-B pediatric). The outcome of the adult use of a child product was unknown and the outcome of the underdose was not reported.   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: 23-JUL-2024 A nurse reported that one of our assistants placed the Engerix-B, 0 to 19 years old, instead of the Adult dose, on 19 July which led to underdose and adult use of a child product.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: don't make it in time for the recommended 2 to 6 month window/given their second dose late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: don't make it in time for the recommended 2 to 6 month window/given their second dose late ). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 23-JUL-2024 The pharmacist stated that in the past there had been patients who did not made it in time for the recommended 2 to 6 month window for the second dose of Shingrix and they were given their second dose late and referred to their provider for further guidance. The patients received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the third one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 47-year-old patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (On 26-MAY-2023 received 1st dose) and Engerix B (On 02-JUN-2023 received 2nd dose).   On an unknown date, the patient did not receive the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: missed the third one). The outcome of the incomplete course of vaccination was unknown.   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: 23-JUL-2024 The pharmacist calls to report that a patient received 2 doses of Engerix B last year (dose 1 and 2) but missed the third one, incomplete course of vaccination. The patient needs to know if they have to start the cycle over. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Gait disturbance, Gait inability, Guillain-Barre syndrome, Walking aid user
Clinical narrative: Guillain Barre Syndrome; weaker and weaker/Losing strngth; uses walker to walk; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 01-APR-2022, the patient received the 1st dose of Shingrix. On 16-OCT-2022, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre Syndrome) (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced weakness (Verbatim: weaker and weaker/Losing strngth) and unable to walk (Verbatim: uses walker to walk). The outcome of the guillain barre syndrome and unable to walk were not resolved and the outcome of the weakness was resolved.   It was unknown if the reporter considered the guillain barre syndrome, weakness and unable to walk to be related to Shingrix. It was unknown if the reporter considered the weakness to be related to Shingrix.     The company considered the guillain barre syndrome to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the weakness and unable to walk to be related to Shingrix. It was unknown if the company considered the weakness to be related to Shingrix.   Additional Information: GSK receipt date: 24-JUL-2024 The reporter stated she received dose and the second dose 2-6 months later (could not remember the dates).  She stated after second dose she became weaker and weaker and could not walk.   On 16th October 2022 she was diagnosed with Guillain Barre syndrome and was being treated for it.  She had not recovered yet and still had to use a walker to help her walk. Not sure if there was another adverse event that was filed earlier. The patient was losing strength until 16th October 2022, which was hospitalized for Guillain Barre syndrome and asked if could be because of vaccine.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1) and Shingrix (Dose 2).