chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Albumin CSF increased, Asthenia, CSF culture negative, CSF protein increased, CSF red blood cell count positive
Clinical narrative: 1. Guillain-Barré Syndrome: Presented to the ED on 2/22 with progressive LE weakness as a pins-and-needles on her arms.  neurology suspected GBS. Etiology unclear, but thought that GBS was precipitated by viral gastroenteritis on 2/19 vs RSV vaccine. Head CT, MRI of brain and spine was negative for source of presenting neurological condition. IVIG was started for 7 days with last date on 2/28.  LP results revealed elevated albumin consistent with albuminocytologic dissociation suggestive of GBS, elevated RBCs which was thought to be secondary to traumatic tap and culture negative with a protein of 104. Pt was intubated as discussed below, is now extubated. Her neurologic status continued to improve and she is gaining strength in upper and lower extremities. Plan to cont working with PT/OT and transfer to acute rehab  2. Hypoxic respiratory failure: Pt was intubated (not emergently) on 2/24 after failing BiPAP and Vapotherm. AHRF thought to be multifactorial in the setting of GBS and aspiration pneumonia. Extubated on 3/2 and reintubated for ventilatory support due to slow improvement in stamina. Pt was under the care of pulmonology/CCU while intubated. She was ultimately extubated on 3/8.  Following extubation the patient's respiratory function steadily improved.  She had a cough productive of yell yellow sputum which progressed to clear sputum and then eventually resolved completely by 3/19.  Patient worked with respiratory therapy and was compliant with using her incentive spirometer multiple times a day.  By 3/18 she no longer required supplemental oxygen.
Age: 85.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Computerised tomogram head normal, Culture negative, Endotracheal intubation, Gastroenteritis viral, Guillain-Barre syndrome
Clinical narrative: 1. Guillain-Barré Syndrome: Presented to the ED on 2/22 with progressive LE weakness as a pins-and-needles on her arms.  neurology suspected GBS. Etiology unclear, but thought that GBS was precipitated by viral gastroenteritis on 2/19 vs RSV vaccine. Head CT, MRI of brain and spine was negative for source of presenting neurological condition. IVIG was started for 7 days with last date on 2/28.  LP results revealed elevated albumin consistent with albuminocytologic dissociation suggestive of GBS, elevated RBCs which was thought to be secondary to traumatic tap and culture negative with a protein of 104. Pt was intubated as discussed below, is now extubated. Her neurologic status continued to improve and she is gaining strength in upper and lower extremities. Plan to cont working with PT/OT and transfer to acute rehab  2. Hypoxic respiratory failure: Pt was intubated (not emergently) on 2/24 after failing BiPAP and Vapotherm. AHRF thought to be multifactorial in the setting of GBS and aspiration pneumonia. Extubated on 3/2 and reintubated for ventilatory support due to slow improvement in stamina. Pt was under the care of pulmonology/CCU while intubated. She was ultimately extubated on 3/8.  Following extubation the patient's respiratory function steadily improved.  She had a cough productive of yell yellow sputum which progressed to clear sputum and then eventually resolved completely by 3/19.  Patient worked with respiratory therapy and was compliant with using her incentive spirometer multiple times a day.  By 3/18 she no longer required supplemental oxygen.
Age: 85.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Immunoglobulin therapy, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Muscular weakness, Neurological decompensation
Clinical narrative: 1. Guillain-Barré Syndrome: Presented to the ED on 2/22 with progressive LE weakness as a pins-and-needles on her arms.  neurology suspected GBS. Etiology unclear, but thought that GBS was precipitated by viral gastroenteritis on 2/19 vs RSV vaccine. Head CT, MRI of brain and spine was negative for source of presenting neurological condition. IVIG was started for 7 days with last date on 2/28.  LP results revealed elevated albumin consistent with albuminocytologic dissociation suggestive of GBS, elevated RBCs which was thought to be secondary to traumatic tap and culture negative with a protein of 104. Pt was intubated as discussed below, is now extubated. Her neurologic status continued to improve and she is gaining strength in upper and lower extremities. Plan to cont working with PT/OT and transfer to acute rehab  2. Hypoxic respiratory failure: Pt was intubated (not emergently) on 2/24 after failing BiPAP and Vapotherm. AHRF thought to be multifactorial in the setting of GBS and aspiration pneumonia. Extubated on 3/2 and reintubated for ventilatory support due to slow improvement in stamina. Pt was under the care of pulmonology/CCU while intubated. She was ultimately extubated on 3/8.  Following extubation the patient's respiratory function steadily improved.  She had a cough productive of yell yellow sputum which progressed to clear sputum and then eventually resolved completely by 3/19.  Patient worked with respiratory therapy and was compliant with using her incentive spirometer multiple times a day.  By 3/18 she no longer required supplemental oxygen.
Age: 85.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Paraesthesia, Pneumonia aspiration, Positive airway pressure therapy, Traumatic lumbar puncture, Treatment failure
Clinical narrative: 1. Guillain-Barré Syndrome: Presented to the ED on 2/22 with progressive LE weakness as a pins-and-needles on her arms.  neurology suspected GBS. Etiology unclear, but thought that GBS was precipitated by viral gastroenteritis on 2/19 vs RSV vaccine. Head CT, MRI of brain and spine was negative for source of presenting neurological condition. IVIG was started for 7 days with last date on 2/28.  LP results revealed elevated albumin consistent with albuminocytologic dissociation suggestive of GBS, elevated RBCs which was thought to be secondary to traumatic tap and culture negative with a protein of 104. Pt was intubated as discussed below, is now extubated. Her neurologic status continued to improve and she is gaining strength in upper and lower extremities. Plan to cont working with PT/OT and transfer to acute rehab  2. Hypoxic respiratory failure: Pt was intubated (not emergently) on 2/24 after failing BiPAP and Vapotherm. AHRF thought to be multifactorial in the setting of GBS and aspiration pneumonia. Extubated on 3/2 and reintubated for ventilatory support due to slow improvement in stamina. Pt was under the care of pulmonology/CCU while intubated. She was ultimately extubated on 3/8.  Following extubation the patient's respiratory function steadily improved.  She had a cough productive of yell yellow sputum which progressed to clear sputum and then eventually resolved completely by 3/19.  Patient worked with respiratory therapy and was compliant with using her incentive spirometer multiple times a day.  By 3/18 she no longer required supplemental oxygen.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Premature menopause
Clinical narrative: Premature Ovarian Failure
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 1.25
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Deafness, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaxcellis was given one week prior to 4 week interval needed between dose 1 & 2. Reporting interval given 3 weeks and not 4 weeks. No adverse side affects at this time.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired no symptoms
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Joint swelling, Pain in extremity
Clinical narrative: Pt c/o pain, redness and swelling in arm after receiving vaccine, 4/22/24. Pt reported vaccine administered in lower part of upper L arm. Pt evaluated and prescribed oral antibiotic and given IM steroid injection. Education provided to staff on appropriate administration.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received 2nd dose of shingrix nearly 2 months ago and called the pharmacy today reporting swelling around the injection site. She states she has had nothing else done on that side and it is precisely where we administered the vaccine. It is painful and hot to the touch but does not itch. No other symptoms at this time. She was instructed to call her provider and attempt a visit to determine if an antibiotic is warranted. This reaction is likely not due to the vaccine, but she should still have it checked out by her provider if it worrisome.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired no symptoms
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired no symptoms
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired no symptoms
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired no symptoms
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Neck pain, Polymyalgia rheumatica
Clinical narrative: Fatigue, debilitated, under the weather, lasted about 8 hours. Around ThanksgivingI woke up with pain on both my shoulders and neck, I though it was soreness from lifting weights or working out. It persisted for 3 weeks and wasgetting worse. I would not open and close my hands. Until I went to see a physician to find out what was going on saw doctor 12/18/2023 with orthopidic Dr., ran nessary test and was Diagnosised with (PMR) Polymyalgia Rhuematica in late January 2024. Saw Rhumatologist 2/16/24 Dr. which confirmed it was PMR.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Fatigue, Migraine, Paranasal sinus discomfort
Clinical narrative: Fetus died within 2 weeks of the Covid booster. Due date was 06/29/24.  Symptoms such as less frequent fetal movement, Sinus pain/pressure, migraine headaches, fatigue began five days after vaccine. Two weeks later symptoms persisted and baby was pronounced dead 2/1/24, with an estimated date of passing  between 1/17/24 and 1/24/24.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: Fetus died within 2 weeks of the Covid booster. Due date was 06/29/24.  Symptoms such as less frequent fetal movement, Sinus pain/pressure, migraine headaches, fatigue began five days after vaccine. Two weeks later symptoms persisted and baby was pronounced dead 2/1/24, with an estimated date of passing  between 1/17/24 and 1/24/24.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pruritus, Rash
Clinical narrative: Patient is a 19-year-old female with history of anxiety who presents with concern for possible reaction to recent rabies vaccination.  Patient had her first dose of RabAvert last Tuesday.  2 days later she began noticing red spots appearing to her bilateral wrists and thighs.  She states that she did notice some spreading proximally in those areas.  She noticed 2 to 3 days ago she developed a different rash to her hands and knees.  She reports minimal itching to the area and denies other signs or symptoms concerning for allergic reaction.  She did take Benadryl twice yesterday which did improve her symptoms on her rash on her legs somewhat.  She is otherwise in her normal state of health and denies any recent new exposures.  Patient was well-appearing in no acute distress on presentation.  Vital signs were unremarkable aside from borderline low blood pressure.  Patient does not appear to be clinically hypotensive or having signs of anaphylaxis or angioedema at this time.  Blood pressure was rechecked and found to be within normal limits.  Physical exam as noted above concerning for macular rash as well as distinctive erythema multiforme lesions.  Discussed with patient that rash likely related to viral infection symptoms last week.  However, given possible reaction to rabies vaccine will have patient's stop current vaccine series and restart with the alternative human diploid vaccine series.  Discussed with nursing staff regarding obtaining alternative vaccine series.  Patient was given dose of 50mg PO Benadryl, 20mg PO famotidine and 10mg PO Decadron while in the office.  She had slight improvement of her symptoms and appeared overall stable at this time.  She was given prescription for steroid burst and continued use of famotidine and Benadryl.  She was given strict return precautions for new or worsening symptoms.  All questions were answered.  Patient was agreeable to plan.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Acupuncture, Computerised tomogram head, Computerised tomogram neck, Impaired work ability, Migraine
Clinical narrative: Migraines- Started with 1st COVID vaccine. Had migraine, nausea, vomiting after each covid vaccine.  Now I have ongoing intermittent migraines AND I had right ear pulsatile tinitus x 1.5 years intermittent- tinitus treated and resolved with accupuncture. Migraines currently ongoing and requiring leave from work. Had CT and MRI of brain and head/neck Vascular system to rule out worse pathology. Unsure if caused by COVID vaccine but I am looking for answers and I've read that other people suffer from these symptoms post covid vaccines. My Migraines tapered off after not having a covid vaccine for a while. Then I recently got a 4th covid vaccine and now they are back almost monthly.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tinnitus, Vomiting
Clinical narrative: Migraines- Started with 1st COVID vaccine. Had migraine, nausea, vomiting after each covid vaccine.  Now I have ongoing intermittent migraines AND I had right ear pulsatile tinitus x 1.5 years intermittent- tinitus treated and resolved with accupuncture. Migraines currently ongoing and requiring leave from work. Had CT and MRI of brain and head/neck Vascular system to rule out worse pathology. Unsure if caused by COVID vaccine but I am looking for answers and I've read that other people suffer from these symptoms post covid vaccines. My Migraines tapered off after not having a covid vaccine for a while. Then I recently got a 4th covid vaccine and now they are back almost monthly.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Patient became pregnant within 1 month of receiving MMR vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Tinnitus
Clinical narrative: First Pfizer shot: 3/13/21 Lot #EN6209.  Second Pfizer shot: 4/3/21, Lot #ER8737.  Hearing loss occurred about 3 weeks later.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: SWELLING, REDNESS, SORENESS, ITCHING. USING ICE PACKS TO TREAT
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: BUD was 4/30/24, dose given after expiration date. No current adverse event/side effects noted
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Erythema, Nausea, Nodule, Pain in extremity
Clinical narrative: arm was very sore, had a knot and bigger bump that can be felt with clothes, red, fever, sick to my stomach, drew a circle to keep an eye on it. Small baseball sized. Fading down a bit. To take ibuprophen for inflammation. I have no appetite.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: arm was very sore, had a knot and bigger bump that can be felt with clothes, red, fever, sick to my stomach, drew a circle to keep an eye on it. Small baseball sized. Fading down a bit. To take ibuprophen for inflammation. I have no appetite.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO ADVERSE REACTIONS WAS REPORTED BY THE PATIENT PARENTS.
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Temperature excusion occurance. Vaccine considered non-viable according to GSK Medical team conformation call.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Pt states that left arm became swollen to the size of a baseball, painful, red and knotted the day after her vaccine and has not since improved. She has been taking benadryl to try to help with symptoms. I advised her to follow up with PCP as soon as possible.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, MNQ, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Medical Assistant administered Menveo in error instead of MMR.  Contacted VFC for guidance.  Monitored in clinic for adverse reaction.  None noted.  MMR has been given.
Age: 64.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Biopsy skin abnormal, Gianotti-Crosti syndrome, Induration, Injection site inflammation, Papule
Clinical narrative: Gianotti-Crosti syndrome. Papules on elbows, in between buttocks, on face. Red and raised. Inflammation of ledt upper arm at the injection site. 1 month after the 2nd injection, arm was hard and swollen for 1 week.
Age: 64.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Peripheral swelling
Clinical narrative: Gianotti-Crosti syndrome. Papules on elbows, in between buttocks, on face. Red and raised. Inflammation of ledt upper arm at the injection site. 1 month after the 2nd injection, arm was hard and swollen for 1 week.
Age: 64.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Biopsy skin abnormal, Gianotti-Crosti syndrome, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: Gianotti-Crosti syndrome. Papules on elbows, in between buttocks, on face. Red and raised. Inflammation of ledt upper arm at the injection site. 1 month after the 2nd injection, arm was hard and swollen for 1 week.
Age: 64.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Injection site warmth, Product administered to patient of inappropriate age, Rash, Skin irritation
Clinical narrative: Gianotti-Crosti syndrome. Papules on elbows, in between buttocks, on face. Red and raised. Inflammation of ledt upper arm at the injection site. 1 month after the 2nd injection, arm was hard and swollen for 1 week.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Pain in extremity, Pelvic pain
Clinical narrative: My hips, pelvis, and upper femurs have an on-going deep ache in the bone.  This pain occurs at all times of day.  I have been addressing the pain as arthritis pain.  I have have adjusted my diet to help minimize the pain.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: I developed atrial fibrillation (AFIB) within 2 weeks of this vaccine. It started as self limiting 15-30 minutes AFIB episodes, but the episodes got longer and more frequent with time. My first 24 hour episode, I was treated in the ER in April, 2023. I now take Metoprolol 50 mg twice a day to prevent AFIB. When I have AFIB episodes, they always require treatment now (I.e. not self limiting).
Age: 3.0
Sex: F
Vaccine: YF
Symptoms: Skin abrasion
Clinical narrative: Yellow Fever vaccine was administered with the help of patient's father who was holding the child. As vaccine was being administered, patient's hand slipped from father's hold. Following administration of all vaccine contents and while needle was still in patient's leg, patient grabbed ahold of and pulled the syringe. This resulted in an approximately 2 inch scrape on patient's right upper leg.   Pressure was applied to scrape, minimal bleeding noted. Bleeding appeared to have stopped at the time patient was dismissed!   Patient's parent was educated on the need to monitor the site for any signs of infection going forward (e.g. increased redness at the site, fever, etc...) and to seek medical care with any concerns. He verified understanding. RN notified provider of the day!
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient inadvertently given Influenza rather than PCV 20
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Eye movement disorder, Posturing, Presyncope
Clinical narrative: After Tdap administration, 5 min, pt with what appeared to be vasovagal like symptoms, sliding down chair, no LOC, some posturing and eye rolling.
Age: 82.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Patient had initially received RSV vaccine on 02/28/24, due to glitch in system it showed that patient was still due for RSV vaccine which resulted in patient receiving a second dose in the same RSV season on 04/19/24. Arexvy Manufrature, GSK has been contacted for further information of possible adverse reaction for second dose received. Report from manufacture showed no concerns regarding efficacy and safety related to second does received. patient daughter has been contacted and notified of the following findings, Daughter reports patient only complaint was expected arm soreness at injection site.
Age: 33.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Left arm had swelling at injection site, some bruising and warm to touch. Applied ice and took Ibuprofen. Resolved in 4 days.
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Rotarix was given at age 7 months, exceeding the age for dose 1.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Fatigue, Pulmonary embolism
Clinical narrative: Patient felt tired and not breathing well starting 4-14-24 ( undetermined time). Dr sent her to hospital on 4-19-24. She had pulmonary embolism in both lungs. She Stayed in hospital until 4-22-24. She was put on Xarelto 2o mg
Age: 1.92
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh with redness and swelling. Bruising in the center with induration and warmth. Started on day 1 after vaccine and became larger per mom
Age: 23.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given out of age range inadvertently.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Rash, Rash erythematous, Rash papular, Wrong product administered
Clinical narrative: It was decided by physician, Dr. that. patient, was not to receive MMR vaccine, but this was given by the Medical assistant. Error was discovered close to 10 pm the evening of 4.11.24 by physician and parents were notified. Patient was seen by physician on 4.12.24. Dr. reported the patient was showing a reaction on her leg. Patient was seen in the Emergency Department on 4.13.24 with a confirmed reticular rash and received 0.6 mg/kg Decadron orally per consult with pediatrics. On 4.15.24 patient was taken to the walk-in clinic for continued reticular rash on arms and legs . A different rash of lesions of erythema about 1-2 mm, slightly elevated. No treatment administered, recommended follow up with pediatrician or clinic for recheck in 3-5 days, if worsening to present to ED. Parent cancelled appointment with pediatrician for 4.25.24 because rash was not improving.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: 2nd dose of RSV given to patient. First dose was 11/29/2023 Abrysvo. Inadvertently given 2nd dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Fatigue, Feeling hot, Immediate post-injection reaction
Clinical narrative: Patient stated that immediately upon injection she felt a burning go all the way down her arm. Stated that she felt nauseous, body aches, and tiredness the first 2 days following administration. Called to report on 05/03/2024 that she was having spreading warmth and redness with red streaks going all the way along her shoulder and arm. Stated that the area is warm to the touch, could not say if was febrile or not due to no working thermometer at home.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site warmth, Nausea
Clinical narrative: Patient stated that immediately upon injection she felt a burning go all the way down her arm. Stated that she felt nauseous, body aches, and tiredness the first 2 days following administration. Called to report on 05/03/2024 that she was having spreading warmth and redness with red streaks going all the way along her shoulder and arm. Stated that the area is warm to the touch, could not say if was febrile or not due to no working thermometer at home.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient stated that immediately upon injection she felt a burning go all the way down her arm. Stated that she felt nauseous, body aches, and tiredness the first 2 days following administration. Called to report on 05/03/2024 that she was having spreading warmth and redness with red streaks going all the way along her shoulder and arm. Stated that the area is warm to the touch, could not say if was febrile or not due to no working thermometer at home.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: patient administered child dose of COVID
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine frozen instead of refrigerated
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient was administered adult Hep A vaccination when patient had two pediatric Hep A vaccinations.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Dizziness, Myocardial infarction, Myocardial necrosis marker increased
Clinical narrative: Cold sweats, dizziness within 24 hours of vaccine. Then it progressed to chills/shakes/extreme nausea. Patient went to the ER where they drew labs and her heart enzymes went from 74 to 700 in 2 hours. Diagnosed with myocardial infarction
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Tremor, Troponin
Clinical narrative: Cold sweats, dizziness within 24 hours of vaccine. Then it progressed to chills/shakes/extreme nausea. Patient went to the ER where they drew labs and her heart enzymes went from 74 to 700 in 2 hours. Diagnosed with myocardial infarction
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: received adult dose
Age: 0.33
Sex: F
Vaccine: PNC15, RV1, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given varivax instead of ordered vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: Irregular and fast heart beats for months
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Red rash/ warm to touch on right thigh
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect route of product administration
Clinical narrative: given subQ and not IM
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received high dose flu vaccine
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Sensory loss, Visual impairment
Clinical narrative: In November, 2023, I received my fifth booster of the Pfizer-BioNTech vaccine. One month later, I developed shingles of the face and eye severe enough to require a week of hospitalization and another three weeks in a rehab facility. I still haven't recovered the feeling in my face and have problems with my eyesight. I had not received the Shingles vaccine.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Headache, swelling and redness at injection site, pain at injection site, itching at injection site.  Prescribed cephalexin and swelling reduced.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Pregnant female received 1 Tdap in 03/22/24 at doctor office, accidentally received  another Tdap in 05/01/2024 at pharmacy
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Swelling
Clinical narrative: visual blindness afterwards, drops for swelling before 20/20.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered. Vaccine expired on 04/30/2024 and Vaccine was administered on 05/03/2024.
Age: 1.58
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient, presented on 4/5/24 for vaccinations. Dtap was ordered, Tdap was given in error. Error was not discovered until 4/30/24. No immediate reaction, provider immediately notified and attempted to contact patient's parents.
Age: 17.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Expired product administered
Clinical narrative: Expired Vaccination given. Vaccine expired on 04/30/2024 and Vaccine was administered on 05/03/2024
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Cough, Secretion discharge
Clinical narrative: Developed thick mucous and  persistent cough
Age: 9.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dizziness, Fall, Joint injury, Loss of consciousness
Clinical narrative: Immunizations given at approximately 10:30am. No immediate adverse reactions noted. She stood and walked out of the clinic room. Child and father walked out of the clinic at approximately 10:40am. Father walked back in carrying the child at that time. He stated that when they got outside she fell to the ground. When dad helped her back up she stated that her eyes got dark and she got dizzy and fell. Dad did not see her fall, but saw her on the ground when he turned around after hearing her fall. She did not hit her head. No injuries other than a scrape to her elbow and knee from where she fell. She was brought back into the clinic room. Vitals taken at that time were b/p 106/54, pulse 64, resp 16, 02 100%. There was no confusion noted. PERRLA. She was answering questions as they were asked. Speech and volume per baseline. Dad states she has never passed out before. She drank water and declined a snack. After sitting in the clinic room for about 5 minutes she stood up and did not feel any symptoms. vitals taken again and were b/p 108/60, pulse 59, resp 16, 02 100%. After standing for about 2-3 minutes she still felt no symptoms. and walked out of the clinic without further incident.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema peripheral, Peripheral swelling, Swelling
Clinical narrative: Patient experienced swelling of the upper arm, armpit, and around collar bone.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient's provider ordered that she be administered  1 dose of 0.3mL of COVID-19 Vaccine, mRNA COMIRNATY for 12 years of age and older. Instead, patient received PFIZER COVID-19 SARS COV2 TODS 6m-4y 3mcg/0.3 ml : 0.3 mL (Route: Intramuscular) given by Medical Assistant on Left Deltoid. This was a medication error. Patient is scheduled for follow up with provider in four weeks.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: When the needle went in, it was painful (and more painful than any other vaccination that I remember). The upper arm was sore and moving the arm was painful, starting at that moment.  I did not have, or develop, any swelling or tenderness or warmth at the injection site. I hoped the pain would resolve in a few days, but it has not resolved to date. There are certain movements I cannot make because of the pain which originates from the shoulder, and range of motion of the left arm is limited compared to the right arm. When I am not moving the arm, there is no pain, but some achiness develops off-and-on depending on how much I move or on the position of the arm. I contacted my GP on the 25th of April (video consult) and she recommended high dose ibuprofen and warm compresses. The ibuprofen takes the edge off the pain but does not eliminate it. I saw my GP for an in-person visit on April 29, 2024. Since the high dose Ibuprofen makes me slightly sleepy, we decided to stop that and try Voltaren gel which also takes a bit of the edge off but does not eliminate the pain nor does it restore range of motion. My GP gave me a referral for an orthopedic specialist and cautioned me in the meantime not to stop using my shoulder for fear of developing "frozen shoulder".
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Morbillivirus test positive, Polymerase chain reaction positive, Rash
Clinical narrative: Positive measles test result represented detection of the live attenuated measles virus used in MMR vaccine; Information has been received from the authors in the published literature article entitled as stated below, referring to a 1-year-old patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)  injection, or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (manufacturer unknown) injection, administered for prophylaxis (lot #, expiry date, anatomical location, and route of administration were not provided).  On an unspecified date, the patient was evaluated for rash illness without documented exposures or plausible epidemiologic risk factors for measles. The rash occurred from 1113 days after administration of their routine first dose of the vaccine, and the patient then received a positive measles test result on syndromic PCR panels for rash illnesses, which concluded that positive test results represented detection of the live attenuated measles virus used in the vaccine (Morbillivirus test positive).  By the time of the report, the outcome of the event was unknown.  The reporting authors considered the positive measles test results to be related to either measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (manufacturer unknown).  This is one of three cases received from the same literature article (linked to 2405USA001104 and 2405USA001105)  Sender's Comments:  US-009507513-2405USA001104: US-009507513-2405USA001105:
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No symptoms or medical concerns reported from this administration/No additional AE; possibly expired vaccine was administered; This spontaneous report was received from a nurse concerning to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  Reporter was checking the immunization records and noticed that on 12-MAR-2013, more that 11 years ago, the patient was administered a possibly expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (reported as " 'Hepatitis B' by Merck; reporter was not able to provide the brand name of the medication"), reported lot number h01856 was an invalid lot number for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date reported as 07-FEB-2013 (dosage regimen, anatomical location , and route of administration were not provided) administered as prophylaxis (expired product administered). No symptoms or medical concerns were reported from this administration (no adverse event). No further information was obtained.
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: Patients mother reported her daughter had headaches after receiving first dose of Gardasil 9.; This spontaneous report has been received from a consumer (patient's mother) referring to her daughter, a female patient of an unknown age.  The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On an unknown date, 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) injection, administered as prophylaxis (strength, dose administered, route of administration, lot # and expiration date were not provided).  On an unknown date (also reported as after receiving first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine [yeast] [GARDASIL 9]), she experienced headaches. At the time of this report, the outcome of the event was unknown.   The causal relationship between headache and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Lot # is being requested and will be submitted if received.
Age: 6.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Morbillivirus test positive, Polymerase chain reaction positive, Rash
Clinical narrative: Positive measles test result represented detection of the live attenuated measles virus used in MMR vaccine; Information has been received from the authors in the published literature article entitled as stated below, referring to a 6-year-old patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)  injection, or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (manufacturer unknown) injection, administered for prophylaxis (lot #, expiry date, anatomical location, and route of administration were not provided).  On an unspecified date, the patient was evaluated for rash illness without documented exposures or plausible epidemiologic risk factors for measles. The rash occurred from 1113 days after administration of their routine first dose of the vaccine, and the patient then received a positive measles test result on syndromic PCR panels for rash illnesses, which concluded that positive test results represented detection of the live attenuated measles virus used in the vaccine (Morbillivirus test positive).  By the time of the report, the outcome of the event was unknown.  The reporting authors considered the positive measles test results to be related to either measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (manufacturer unknown).  This is one of three cases received from the same literature article (linked to 2404USA004808 and 2405USA001105)  Sender's Comments:  US-009507513-2404USA004808: US-009507513-2405USA001105:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles; Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and pain (Verbatim: Pain). The outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2024 This case was reported by parent via interactive digital media A reporter reported that his/her son got shingles between his shots.  The reporter stated patient wait about 6 months before he could get the 2nd shot.  The reporter stated that, could get them again, the case would not be as bad as the first one, but the pain was there.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient has not yet received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11-APR-2023 from batch number D734X with expiry date 28-MAY-2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient has not yet received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-APR-2024 The pharmacist reported that a patient had not yet receive second dose of Shingrix.  The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination. The reporter consented to follow up.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient came in and he received the dose of the HepB 11 days ago; 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 49-year-old male patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On 22-APR-2024, the patient received the 2nd dose of Engerix B. On 22-APR-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: patient came in and he received the dose of the HepB 11 days ago). 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: 22-APR-2024 The  pharmacist called to inform the following, today (on the day of reporting) there was a medical error with Hepatitis B vaccine, specifically the Engerix-B.  That patient came in and he received the dose of the HepB 11 days ago, and on the reporting day the medical assistant gave another HepB 11 days later, which led to shortening of vaccination schedule.
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Blister, Influenza, Injection site pain, Nasopharyngitis, Pyrexia
Clinical narrative: Pain at the injection site; he experienced fever; flu symptoms; cold symptoms; two fluid filled blisters (shoulder and stomach); This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On 27-DEC-2023, the patient received the 1st dose of Shingrix (intramuscular, right deltoid) and COVID-19 vaccine (left deltoid). On 28-DEC-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at the injection site), fever (Verbatim: he experienced fever), influenza (Verbatim: flu symptoms), cold symptoms (Verbatim: cold symptoms) and blister (Verbatim: two fluid filled blisters (shoulder and stomach)). On 31-DEC-2023, the outcome of the injection site pain, fever, influenza, cold symptoms and blister were resolved (duration 3 days).   It was unknown if the reporter considered the injection site pain, fever, influenza, cold symptoms and blister to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever, influenza, cold symptoms and blister to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR054616   Additional Information: GSK Receipt Date: 22-APR-2024 The reporter reported that he received his Shingrix vaccination and a Covid-19 vaccine (unknown manufacturer).  One day following that doses, he experienced fever, pain at the injection site, cold/flu symptoms and two fluid-filled blisters (shoulder and stomach).  These symptoms resolved in about 3 days. It was unknown if the reporter considered the fever, injection site pain, influenza, cold symptoms and blister to be related to Covid-19. For tolerance of 2nd dose of Shingrix, refer case US2024AMR054616.; Sender's Comments:  US-GSK-US2024AMR054616:same reporter
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Monoplegia, Pain, Pain in extremity
Clinical narrative: the patient began to experience paralyzing; spiking pain in the injected arm; This serious case was reported by a consumer via call center representative and described the occurrence of arm paralysis in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included poliomyelitis (Polio disease as a child).   On 22-APR-2024, the patient received the 1st dose of Shingrix (left deltoid). On 22-APR-2024, 2 hrs after receiving Shingrix, the patient experienced arm paralysis (Verbatim: the patient began to experience paralyzing) (serious criteria GSK medically significant) and pain in extremity (Verbatim: spiking pain in the injected arm). The patient was treated with paracetamol (Acetaminophen). The outcome of the arm paralysis and pain in extremity were not resolved.   It was unknown if the reporter considered the arm paralysis and pain in extremity to be related to Shingrix.     It was unknown if the company considered the arm paralysis and pain in extremity to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-APR-2024 The reporter was the wife of the patient. The patient also took part in the conversation and provided some information. The patient received the Shingrix vaccine on reporting day in the upper left arm. About 2.5 hours later, the patient began to experience paralyzing, spiking pain in the injected arm. Patient describes this pain like the pain from a torn rotator cuff. The patient had massaged the injected site prior to experiencing the paralyzing, spiking pain. The patient took 1500 milligram of acetaminophen to treat the pain, which gave a tiny bit of relief. The patient also used cold to the injected site which made the pain worse. This case had been linked with the case US2024051392, reported by same reporter.; Sender's Comments:  US-GSK-US2024051392:same reporter/ Different patient