chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine was frozen instead refrigerated.
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: MMR expired on 5/10/24
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident, Chest pain, Gait inability, Hemiparesis
Clinical narrative: I had a stroke at 22 years old less than 6 months after my last vaccination which left me with palpitations every single day with chest pain. The entire left side of my body gave out of 02/04/22 when i had my stroke, i couldn?t talk or walk when i got brought by ambulance to ER. After that i had TPA and a thrombectomy procedure to remove the clot. I still have some residual issues due to this, 2 years later. I also now have to be on long term anticoagulants until, as a 22 year old being on warfarin the rest of your life does not sound great.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Laboratory test, Mitral valve disease, Palpitations, Thrombectomy
Clinical narrative: I had a stroke at 22 years old less than 6 months after my last vaccination which left me with palpitations every single day with chest pain. The entire left side of my body gave out of 02/04/22 when i had my stroke, i couldn?t talk or walk when i got brought by ambulance to ER. After that i had TPA and a thrombectomy procedure to remove the clot. I still have some residual issues due to this, 2 years later. I also now have to be on long term anticoagulants until, as a 22 year old being on warfarin the rest of your life does not sound great.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: I had a stroke at 22 years old less than 6 months after my last vaccination which left me with palpitations every single day with chest pain. The entire left side of my body gave out of 02/04/22 when i had my stroke, i couldn?t talk or walk when i got brought by ambulance to ER. After that i had TPA and a thrombectomy procedure to remove the clot. I still have some residual issues due to this, 2 years later. I also now have to be on long term anticoagulants until, as a 22 year old being on warfarin the rest of your life does not sound great.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: EGFR gene mutation, Laboratory test, Lung adenocarcinoma, Lung adenocarcinoma stage IV, Lung lobectomy
Clinical narrative: Stage 2/3 Adeno Carcinoma lung cancer with EGFR mutation  in left lung detected in March 2022 one year after commencement of Moderna covid vaccine. Nothing else changed in my life except for the vaccine. I believe this caused the genetic mutation to activate since Moderna was RNA based vaccine.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine was frozen instead refrigerated.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Unevaluable event
Clinical narrative: Patient administered rotarix when not eligible (> 14w6d of life).
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Myocardial infarction, Myocarditis, Pericardial effusion, Syncope
Clinical narrative: This patient stated that he had been diagnosed with "myocarditis/pericardial effusion " diagnosed April 22, 2024 as this patient stated that he had to go to the ER that day for "fainting spells  and a slight heart attack".  This patient informed this PHN that he also had been given a Tdap also on 02/26/24  elsewhere.  Clinic administered the Hepatitis B vaccine to this patient only on 03/27/24.  This patient stated that the inflammation around the heart is "coming down" and he did have an echocardiogram recently, "and the fluid is gone."  This patient stated that the doctor told him that this could be idiopathic in nature or he could have had a virus that could have caused this, the doctor recommended a VAERS report be completed.  This patient is on light duty until Oct. 2024 per patient report.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead refrigerated.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram thorax abnormal, Cough, Dyspnoea, Gait disturbance
Clinical narrative: Shortness of breath swimming head. Oxygen was 80 and pulse was 165 BPM. Unable to climb steps or perform any tasks that were physically exerting, Continuous coughing every 10 to 15 seconds. For several days before emergency room treatment and 3 days in hospital. Administered in ER, clot busters and blood thinner via IV. Left hospital after three days on Heprin and was transitioned to Elquis 5 mg blood thinner, which i am still taking. Tests were a CT scan of chest area with contrast and Doppler of both legs. CT scan revealed a center pulmonary embolism. Doppler on legs revealed two blood clots in left leg one above the knee and one below the knee. No trips were taken prior to incident stated above. Treatment is still ongoing Next CT is in two months.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Pulmonary embolism, Scan with contrast abnormal, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Shortness of breath swimming head. Oxygen was 80 and pulse was 165 BPM. Unable to climb steps or perform any tasks that were physically exerting, Continuous coughing every 10 to 15 seconds. For several days before emergency room treatment and 3 days in hospital. Administered in ER, clot busters and blood thinner via IV. Left hospital after three days on Heprin and was transitioned to Elquis 5 mg blood thinner, which i am still taking. Tests were a CT scan of chest area with contrast and Doppler of both legs. CT scan revealed a center pulmonary embolism. Doppler on legs revealed two blood clots in left leg one above the knee and one below the knee. No trips were taken prior to incident stated above. Treatment is still ongoing Next CT is in two months.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Shortness of breath swimming head. Oxygen was 80 and pulse was 165 BPM. Unable to climb steps or perform any tasks that were physically exerting, Continuous coughing every 10 to 15 seconds. For several days before emergency room treatment and 3 days in hospital. Administered in ER, clot busters and blood thinner via IV. Left hospital after three days on Heprin and was transitioned to Elquis 5 mg blood thinner, which i am still taking. Tests were a CT scan of chest area with contrast and Doppler of both legs. CT scan revealed a center pulmonary embolism. Doppler on legs revealed two blood clots in left leg one above the knee and one below the knee. No trips were taken prior to incident stated above. Treatment is still ongoing Next CT is in two months.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead refrigerated.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Patient describes a swelling in the left arm, along with areas of itching. Symptoms started about 2-3 weeks after Shingrix.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects known
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Skin: Warm, dry, well-perfused. No rashes, 14 x 15 cm area of redness and swelling on his left lateral upper arm,  no other lesions. Cellulitis of left upper arm (L03.114) Allergic reaction to vaccine (T80.69XA) Patient got his meningococcal and his Tdap injections 2 days ago in his left upper arm.  This is likely a reaction to the Tdap injection.  Patient was given a prescription for Medrol Dosepak to calm down inflammation and swelling.  Also was given a prescription of cephalexin to treat for secondary infection.  Patient was given recommendation to not get another Tdap injection in his future, may use tetanus but not the pertussis component.  Follow-up if his symptoms or not improving in 2 days.  Follow-up as needed.
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Fatigue, Myositis, Red blood cell sedimentation rate increased, Rheumatoid arthritis
Clinical narrative: Severe rheumatoid arthritis. Severe fatigue. Myocytis.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac monitoring normal, Dizziness, Echocardiogram normal, Exercise tolerance decreased, Heart rate increased
Clinical narrative: Covid positive 8/15/22 with new onset POTS symptoms on day 9 of covid infection 8/23/22. POTS symptoms (high heart rate and palpitations on standing, episodes of dizziness - orthostatic intolerance) improving slowly overall with rest, decreased activity and decreased exercise from late august 2022 through mid-november 2022 - Overall improved but not completely resolved by the time of 11/13/22 covid booster. I then received Moderna mRNA covid booster on 11/13/22, and immediately on the same day as booster received - POTS symptoms including racing heart rate and palpitations on standing became worse again, episodes of dizziness on standing, exercise intolerance, fatigue .  Symptoms worsened from 11/13/22 to June 2023.  Took time off work and learned to pace July 2023. Symptoms slowly improving July 2023 to present, but not resolved.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immediate post-injection reaction, Impaired work ability, Orthostatic intolerance, Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: Covid positive 8/15/22 with new onset POTS symptoms on day 9 of covid infection 8/23/22. POTS symptoms (high heart rate and palpitations on standing, episodes of dizziness - orthostatic intolerance) improving slowly overall with rest, decreased activity and decreased exercise from late august 2022 through mid-november 2022 - Overall improved but not completely resolved by the time of 11/13/22 covid booster. I then received Moderna mRNA covid booster on 11/13/22, and immediately on the same day as booster received - POTS symptoms including racing heart rate and palpitations on standing became worse again, episodes of dizziness on standing, exercise intolerance, fatigue .  Symptoms worsened from 11/13/22 to June 2023.  Took time off work and learned to pace July 2023. Symptoms slowly improving July 2023 to present, but not resolved.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Tilt table test positive
Clinical narrative: Covid positive 8/15/22 with new onset POTS symptoms on day 9 of covid infection 8/23/22. POTS symptoms (high heart rate and palpitations on standing, episodes of dizziness - orthostatic intolerance) improving slowly overall with rest, decreased activity and decreased exercise from late august 2022 through mid-november 2022 - Overall improved but not completely resolved by the time of 11/13/22 covid booster. I then received Moderna mRNA covid booster on 11/13/22, and immediately on the same day as booster received - POTS symptoms including racing heart rate and palpitations on standing became worse again, episodes of dizziness on standing, exercise intolerance, fatigue .  Symptoms worsened from 11/13/22 to June 2023.  Took time off work and learned to pace July 2023. Symptoms slowly improving July 2023 to present, but not resolved.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: age inappropriate vaccine
Age: 50.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling, Tendonitis, Ultrasound scan normal
Clinical narrative: After 5/3/24 visit receiving Td vaccine, went home did mowing, running with son, etc, and the following day watching son's baseball game on a cold bench when getting up felt Rt hip down leg to shin/calf progressive pain that following day became severe, also Rt leg swelling, went to ER, no records, says US neg for DVT, xrays showed hip calcitis and tendonitis.  Per pt, ER providers noted low suspicion that symptoms are related to vaccine, which is also my assessment.  While vaccine adverse event is a possibility, the likelihood seems not high.  Of note, pt notes history years ago of Rt leg injury from soccer.
Age: 50.0
Sex: M
Vaccine: TD
Symptoms: X-ray of pelvis and hip abnormal
Clinical narrative: After 5/3/24 visit receiving Td vaccine, went home did mowing, running with son, etc, and the following day watching son's baseball game on a cold bench when getting up felt Rt hip down leg to shin/calf progressive pain that following day became severe, also Rt leg swelling, went to ER, no records, says US neg for DVT, xrays showed hip calcitis and tendonitis.  Per pt, ER providers noted low suspicion that symptoms are related to vaccine, which is also my assessment.  While vaccine adverse event is a possibility, the likelihood seems not high.  Of note, pt notes history years ago of Rt leg injury from soccer.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test, Sneezing
Clinical narrative: Cough, sneezing, nasal congestion, sore throat
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: redness, swelling itchiness of the right arm, spreading for 2 days
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects known
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness, Malaise, Palpitations, Paraesthesia
Clinical narrative: The patient called and said she did not feel well about 30 minutes after getting Meningitis vaccine today. The patient states she feels like she has pins and needles, blacked out, heart racing, and passed out. The patient denies difficulty breathing. The patient is unsure if the site is swollen, but is hot. The patient states she passed out for 3 seconds. Patient states her vision went fuzzy. Patient states she feels nauseous. Patient denies any lip tingling. Patient states she noticed the symptoms about 30 minutes. Patient states she feels very weak. Patient denies any new drug. Patient can move her arm. Patient has neck pain, but can bend her chin down to her chest. Patient states her fast heart rate was fast and felt like she was out of breath, but since sitting it is helping. Patient the nausea was gradual, but the other symptoms came on fast. Patient states she feels cold, severe headache, and nausea and weak. After speaking with provider, RN informed patient to go to ED. RN informed patient not to drive herself.
Age: 44.0
Sex: F
Vaccine: HEPA, RAB
Symptoms: Rash, Rash erythematous
Clinical narrative: red rash around both eyes. gradual resolution w/ benadryl and other OTC (unspecified by patient) over the course of the following month.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects known
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Induration, Peripheral swelling, Skin warm
Clinical narrative: The patient's mom emailed me and this is what she report: "When we got up Saturday morning, left arm was really swollen and hard to touch as well as being hot to touch. Is there any way I can get a copy of what vaccinations you all gave him in the school? Urgent Care told me to take him to the hospital so that they can do blood work and x-rays or whatever they needed to do to find out what was going on." I informed the parent that the patient received Tdap vaccine in his Left Deltoid and that it was common to have some redness, swelling and warmth. I told her that if there was an increase in the symptoms or if they did not get better, that she should contact their primary care provider.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Allergy test negative, Urticaria
Clinical narrative: I developed horrible total body hives which continue to present. I had rheumatic fever as a child which occurred after a strept infection,My body overreacts to strept..There is no warning in the Prevnar literature that cautions people if they have hightened reaction to strep... Vaccine is made with sugars from strep bacteria. Allergist did extensive testing , all negative and felt it was from this vaccine. I think a warning needs to be part of the literature... This chronic hives situation has been awful.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Patient reports rash on face, neck, and chest on 05/13/2024 that she believes is related to the MMR vaccine. This nurse discussed concerns with Medical Director. Patient stated she took benadryl to relieve itching this morning.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects noted
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Blood culture negative, Blood glucose increased, CSF culture negative, Chest X-ray normal, Computerised tomogram head abnormal
Clinical narrative: several febrile seizures in a row
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Culture urine negative, Drug screen negative, Electrocardiogram normal, Electroencephalogram normal, Enterovirus infection
Clinical narrative: several febrile seizures in a row
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Enterovirus test positive, External hydrocephalus, Febrile convulsion, Full blood count, Human rhinovirus test positive
Clinical narrative: several febrile seizures in a row
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Metabolic function test, Rhinovirus infection, Urodynamics measurement, White blood cells urine positive
Clinical narrative: several febrile seizures in a row
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event. Immunization report with incomplete information did not show original dose so when patient inquired, a dose was administered.  Found out a week later it was a duplicate dose.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Product prescribing error, Wrong product administered
Clinical narrative: Patient was supposed to get Hep B vaccination. Men B was ordered and given.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site urticaria, Local reaction
Clinical narrative: Patient received 4 tdap vaccines within 6yrs during each pregnancy. With the last vaccine (4th)  patient experienced a local site reaction that included hives and redness. Patients stayed in the office until it was safe for her to leave.
Age: 7.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event occurred- reporting the administration error only. Per CDC, the only risk to the patient is the chance of increased local site reaction. Patient's parent notified.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Rhinorrhoea
Clinical narrative: Chronic overproduction of mucous within sinus cavity for four years since injection.  Has flu-like symptoms without inciting pathogen isolated for 1 to 2 weeks every month
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Detoxification, Dizziness, Ecchymosis, Echocardiogram
Clinical narrative: PFIZER #1 4/16/2021 PFIZER #2 6/16/2021 DEVELOPED VACCINE INDUCED POTS 3 DAYS AFTER FIRST DOSE AND WORSENED WITH THE SECOND DOSE.  HAS FREQUENT EPISODES OF DIZZINESS, NEAR SYNCOPE, AND OCCASIONAL SYNCOPE, HAS EPISODES OF TACHYCARDIA OUT OF PROPORTION TO EXERCISE.  WAS IN SPECIFIED PROFESSIONAL BASEBALL CLUB SYSTEM AND NOW CANNOT PLAY BASEBALL.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Imaging procedure, Laboratory test, Loss of personal independence in daily activities, Postural orthostatic tachycardia syndrome, Presyncope
Clinical narrative: PFIZER #1 4/16/2021 PFIZER #2 6/16/2021 DEVELOPED VACCINE INDUCED POTS 3 DAYS AFTER FIRST DOSE AND WORSENED WITH THE SECOND DOSE.  HAS FREQUENT EPISODES OF DIZZINESS, NEAR SYNCOPE, AND OCCASIONAL SYNCOPE, HAS EPISODES OF TACHYCARDIA OUT OF PROPORTION TO EXERCISE.  WAS IN SPECIFIED PROFESSIONAL BASEBALL CLUB SYSTEM AND NOW CANNOT PLAY BASEBALL.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope, Tachycardia
Clinical narrative: PFIZER #1 4/16/2021 PFIZER #2 6/16/2021 DEVELOPED VACCINE INDUCED POTS 3 DAYS AFTER FIRST DOSE AND WORSENED WITH THE SECOND DOSE.  HAS FREQUENT EPISODES OF DIZZINESS, NEAR SYNCOPE, AND OCCASIONAL SYNCOPE, HAS EPISODES OF TACHYCARDIA OUT OF PROPORTION TO EXERCISE.  WAS IN SPECIFIED PROFESSIONAL BASEBALL CLUB SYSTEM AND NOW CANNOT PLAY BASEBALL.
Age: 64.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Abdominal discomfort, Malaise, Nausea, Pain
Clinical narrative: Patient reports nausea and upset stomach and body ache that developed in the early hours of the next morning. Patient came to the clinic to see his PCP after 4 days stating that he continues to feel unwel.
Age: 64.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Myalgia, Nausea
Clinical narrative: Patient reports nausea and upset stomach and body ache that developed in the early hours of the next morning. Patient came to the clinic to see his PCP after 4 days stating that he continues to feel unwel.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nerve damage, Pain, Pain in extremity
Clinical narrative: Pain in the arm getting worse with days progressing to a point where even moving the arm slightly from the shoulder would cause a pain score of 9.5 out of 10 on the pain scale.
Age: 32.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: 1 day after the administration HPV vaccination patient has right arm swelling, redness of the deltoid with mild pruritus.
Age: 21.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Hypoaesthesia, Malaise
Clinical narrative: PT WAS GIVEN IMMUNIZATION AND AFTER WAITING THE APPROPRIATE AMOUNT OF TIME LEFT THE CLINIC. PT STATES AFTER LEAVING THE CLINIC PT STARTED TO NOT FEEL WELL. PT STATES LOSING FEELING IN LEFT ARM AND WENT TO LOCAL ED. PT RECEIVED ANTIHISTAMINE PO AND WAS DISCHARGED.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare, Rash, Skin culture positive, Skin disorder
Clinical narrative: started outlooking like a bug bite then formed a ring of bumps.  consulted several doctors who treated me for ring worm but the reaction only got bigger and bigger. Dermatologist took a culture and it was determined it was granuloma annulare. She tried steroid injections but it didn't help. The first one started to heal then another popped up. The second is still reacting today. It took 2 years for the first to go away. The second popped up right as the 1st was diminishing
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: Severe ischemic stroke
Age: 29.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient has not reported any symptoms; Nurse calling to reported administering third dose of GARDASIL 9 to 31-year-old patient 3 days early. Caller stated patient received first dose on 6/27/2022, second dose 8/9/2022 and final dose on 9/6/2022.; This spontaneous report as received from a registered nurse, referring to a 29 years old (also reported as 31 years old, conflicting information) female patient. The patient current condition included fibromyalgia, vitamin D insufficiency, hypertriglyceridaemia, anxiety and depression. Information regarding the patient's historical condition and concomitant medication was not provided.  On 27-JUN-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose: one dose, lot # 1775811 with expiration date: 07-DEC-2023, strength unknown), intramuscularly in the left deltoid for prophylaxis. On 09-AUG-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # W010663 with expiration date: 11-MAR-2024, dose and strength were unknown), intramuscularly in the left deltoid for prophylaxis. On 06-SEP-2022, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1780876 with expiration date: 09-NOV-2023, dose and strength unknown), intramuscularly in the right deltoid for prophylaxis (inappropriate schedule of product administration). The patient has not reported any symptoms. It was unknown if the vaccine or vaccine-device available for return or evaluation. The operator of vaccine or vaccine or vaccine-device was unknown.
Sex: M
Vaccine: PNC15, PPV
Symptoms: Myelodysplastic syndrome
Clinical narrative: pneumococcal vaccine titers were not protective; the patient with myelodysplasia; This literature marketed report has been received from the authors of a published literature article, titled as stated below refers to a 5-year-old male patient. He had a rare variant in SAMD9. He presented with mild neutropenia and thrombocytopenia, thought to be viral induced. He also had history of recurrent otitis media and two episodes of pneumonia. Immune phenotyping showed normal immunoglobulins, mild B and NK cell lymphopenia and mild naive T-cell skewing. He was diagnosed with megakaryocyctic myelodysplasia with monosomy 7 consistent with myelodysplastic syndrome. The patient's concomitants therapies were not provided.   On an unknown date, the patient was vaccinated with unspecified pneumococcal vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot #, expiration date were not provided) for prophylaxis.   On an unknown date, pneumococcal vaccine titers were  not protective. The outcome of the event was not provided.   The authors of the article considered the event to be related to pneumococcal vaccine (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.  Lot # is being requested and will be submitted if received.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, Pain in extremity, Wrong patient received product
Clinical narrative: sore arm; HCP is calling to report that a 16 year old patient was inadverntly administered two doses of the GARDASIL 9 vaccine in the same day.  HCP stated that the vaccines were administered due to medication error of the staff. HCP was probed for any potenti; Caller reports that her other college aged daughter was supposed to get an HPV shot as well, but they gave both shots to her 16 yo daughter; This spontaneous report was received from  a physician and refered to a 16-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-MAY-2024, the patient was inadverntly administered two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X024560, expiration date: 31-MAY-2026, administered for prophylaxis due to medication error of the staff (strengths, anatomical locations, and routes of administration were not provided) (accidental overdose). It was stated that other patient was supposed to get the shot as well, but they gave both shots to the 16 yo patient (Wrong patient received product).   On 08-MAY-2024, reported as after the second shot occurred, the patient experienced sore arm (Pain in extremity), but the patient draws so the reporter was not sure if it was related to the shot or not. The outcome of the event pain in extremity was not reported.   The causal relationship between Pain in extremity and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse called to report TE where products have been administered to patients.; No additional AE; This spontaneous report was received from a nurse and refers to a currently 2-years-old patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with  an  improperly stored pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection,  (strength, dose, dose#, lot #, expiry date, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (product storage error). The suspect vaccine underwent temperature excursion of 9.85 Celsius degrees for 30 minutes. There was no previous temperature excursion. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pharmacist reports no symptoms or side effects/no futher AE i; Pharmacist called to request that a dose of PROQUAD that expired on 8/29/2021, was administered on 4/27/2024.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 27-APR-2024, the patient was vaccinated with an expired dose of a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #T007395, expiration date: 29-AUG-2021, (strength, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (Expired product administered). The pharmacist reports no symptoms or side effects (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: The HCP reports no symptomatic adverse events.; a patient was inadvertently administered an expired dose of MMR II; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT). The information regarding the patient's concurrent conditions or medical history was not reported.  On 08-MAY-2024, the patient was inadvertently vaccinated with expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) at a dose of 0.5 mL, lot# W034211 that was found to be non-valid, expiry date reported as 30-APR-2024, for prophylaxis (route of administration and anatomical location were not reported) (expired product administered). The vaccine did not suffer any temperature excursions. No symptomatic adverse events were reported (no adverse event).  Additional information is not expected.
Sex: F
Vaccine: TYP
Symptoms: Pyelonephritis, Urinary tract infection
Clinical narrative: UTI / Pyelonephritis; Case reference number US-BN-2024-001868 is a spontaneous case report initially received from a pharmacist via Company (reference number: USBAV24-0922) on 03-May-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient had taken a dose of Vivotif (batch number: unknown) at an unknown dose, reported as was mid cycle, orally, for typhoid immunization.   On an unspecified date, an unknown amount of time after Vivotif, the patient had urinary tract infection (UTI). As reported, the patient should be treated with antibiotics.  As reported, the reporter was asking about possible treatment with Bactrim (sulfamethoxazole and trimethoprim), and should the patient stopping treatment with Vivotif, and then restart it three days after completing antibiotics. As reported, whichever antibiotic treatment the patient would receive, should cover pyelonephritis.  At the time of the initial report, the outcome of the event UTI / pyelonephritis was unknown.  The reporter assessed the event of UTI / pyelonephritis as non-serious, however the event of UTI / pyelonephritis was assessed as serious due to criteria of medical significance. The reporter assessed the event of UTI / pyelonephritis as possibly related to Vivotif.  No further information was provided.; Reporter's Comments: A female patient of unknown age experienced a serious event of pyelonephritis on an unspecified date, an unknown amount of time after the patient had taken a dose of Vivotif for typhoid immunization. Pyelonephritis is unlisted and unexpected for Vivotif according to the CCDS v8 and PI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported event has been considered as related to Vivotif. This case is considered as serious due to medical significance.; Sender's Comments: A female patient of unknown age experienced a serious event of pyelonephritis on an unspecified date, an unknown amount of time after the patient had taken a dose of Vivotif for typhoid immunization. Pyelonephritis is unlisted and unexpected for Vivotif according to the CCDS v8 and PI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported event has been considered as related to Vivotif. This case is considered as serious due to medical significance.
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Fainting; This serious case was reported by a physician via sales rep and described the occurrence of fainting in a patient who received Men B NVS (Bexsero) for prophylaxis.   In MAY-2024, the patient received Bexsero (unknown arm). In MAY-2024, an unknown time after receiving Bexsero, the patient experienced fainting (Verbatim: Fainting) (serious criteria GSK medically significant). The outcome of the fainting was unknown.   The reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the fainting 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: 07-MAY-2024 The patient's age was reported as 2 decades.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Plasmapheresis
Clinical narrative: guillain barre syndrome/gbs; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: guillain barre syndrome/gbs) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   The reporter considered the guillain barre syndrome to be related to Shingles vaccine.     The company considered the guillain barre syndrome to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAY-2024 The patient had guillain barre syndrome due to a reaction to the vaccine. The patient had a complete change of blood plasma 5 times over 10 days to clear the antigens. The patient think the incidence rate was something like 3 in a million, so very unlikely, but could happen.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: get shingles even if you are fully vaccinated like I am./Suspected vaccination failure; shingle; rash; 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: get shingles even if you are fully vaccinated like I am./Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingle) and rash (Verbatim: rash). The outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAY-2024 The case was received from the patient via interactive digital media.   The reporter state we can have shingles even if fully vaccinated like he/she was.  The reporter stated it was just a milder case with the rash but not the severe pain. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: dose of Tdap given in same pregnancy; prescription on a separate day for RSV, but was given TDaP; 2 doses of Tdap given in same pregnancy; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Boostrix (unknown arm) and the 1st dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix and Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: dose of Tdap given in same pregnancy), wrong vaccine administered (Verbatim: prescription on a separate day for RSV, but was given TDaP) and extra dose administered (Verbatim: 2 doses of Tdap given in same pregnancy). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and extra dose administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 03-May-2024 The reporter reported that the patient received two doses of Tdap in same pregnancy. The pregnant woman brought the prescription for TDaP and was administered, then brought another prescription on a separate day for RSV, but was given TDaP again, which led to wrong vaccine administered and extra dose administered. No reaction was noted as of report date. The reporter wanted to know if there any additional information about the adverse event. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nerve injury
Clinical narrative: friend experienced nerve damage; Headache; This non-serious case was reported by a consumer and described the occurrence of nerve damage in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced nerve damage (Verbatim: friend experienced nerve damage) and headache (Verbatim: Headache). The outcome of the nerve damage and headache were resolved (duration 6 months).   It was unknown if the reporter considered the nerve damage and headache to be related to Shingrix.     It was unknown if the company considered the nerve damage and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2024 The reporter described an event which was experienced by her friend (patient).  The reporter stated after receiving the 2nd dose of Shingrix vaccine, a friend experienced nerve damage and headaches which took 6 months to resolve.  The reporter could not remember the last name of the friend. This case was linked with US2024049212, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2024049212:other link
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Skin ulcer
Clinical narrative: pounding headache; sores on ear; This non-serious case was reported by a consumer via call center representative and described the occurrence of pounding in head in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2024, the patient received the 1st dose of Shingrix. In APR-2024, 3 days after receiving Shingrix, the patient experienced pounding in head (Verbatim: pounding headache) and ear pain (Verbatim: sores on ear). In APR-2024, the outcome of the pounding in head was resolved (duration 3 weeks) and the outcome of the ear pain was resolved (duration 2 weeks).   It was unknown if the reporter considered the pounding in head and ear pain to be related to Shingrix.     It was unknown if the company considered the pounding in head and ear pain to be related to Shingrix.   Additional Information: GSK receipt date: 03-MAY-2024 Reporter stated that he received his first Shingrix vaccination about a month ago.   He reported that 3 to 5 days after the vaccination he experienced sores on his ear which lasted about 3 weeks and a pounding headache which resolved in about 2 weeks. Consented to follow up. The case is linked with US2024056865, by same reporter.; Sender's Comments:  US-GSK-US2024056865:Same reporter,Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: He mentioned in passing that a woman at church got the SHINGRIX shot and "got sick."; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: He mentioned in passing that a woman at church got the SHINGRIX shot and "got sick."). The outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2024 The reporter was reporting adverse events for his wife and himself.  He mentioned in passing that a woman at church got the Shingrix shot and got sick. He had no additional details. The reporter did not consent to follow-up. The case had been linked to US2024056865, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024056865:Same reporter,Different patient
Sex: F
Vaccine: HIBV
Symptoms: Injury associated with device, Needle issue
Clinical narrative: needle stick to her right thumb.; needle fell off causing a needle stick to her right thumb; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental needle stick in a adult female patient who received Hib (Hiberix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient did not receive Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: needle stick to her right thumb.), needle issue (Verbatim: needle fell off causing a needle stick to her right thumb) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental needle stick was resolved and the outcome of the needle issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the accidental needle stick to be related to Hiberix.     It was unknown if the company considered the accidental needle stick to be related to Hiberix.   Additional Information: GSK Receipt Date: 03-MAY-2024 and 08-MAY-2024 The reporter reported that she managed multiple facilities and had been given multiple reports of the same complaint concerning multiple lots of suspect products.  The reporter did not have lot numbers, did not have number of doses involved and could not answer any PQC specific questions.  The reporter stated that needles were not attaching correctly to the new presentation of the suspect product. It reported that one nurse was recapping safety mechanism after administration of suspect product and needle fell off causing a needle stick to her right thumb.  The reporter stated that she was not asking for credit and did not have any of suspect products to return to the Quality Department. The reporter consented to follow up.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: accidentally administered the adjuvant portion of Shingrix only; accidentally administered the adjuvant portion of Shingrix only; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 40-year-old female patient who received Herpes zoster (Shingrix) (batch number 7992N, expiry date 01-MAY-2026) for prophylaxis.   On 02-MAY-2024, the patient received Shingrix. On 02-MAY-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: accidentally administered the adjuvant portion of Shingrix only) and inappropriate preparation of medication (Verbatim: accidentally administered the adjuvant portion of Shingrix only). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date: 03-MAY-2024 The nurse accidentally administered the adjuvant portion of Shingrix only to a female patient which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.