chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Oropharyngeal discomfort, Swelling face, Swollen tongue, Urticaria
Clinical narrative: 4/4 developed "huge welt on arm that grew for days". then on the mornings of 4/6, 4/7, and 4/8 she woke up with "swollen lips" ten on 4/8 swelling spread to jawline and also affected tongue. also had abnormal sensation in throat so went tothe ER. and was given epinephrine. vitals normal at ED. no rash. no GI symptoms. given IM epi and symptoms resovled after 1 dose.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: patient awoke the day following injection with large red area of induration with noticeable warm and itching.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal distension, Amnesia, Anal pruritus, Anxiety, Blood test
Clinical narrative: The day after the first dose of COVID mRNA vaccination I began feeling extremely fatigued, followed by brain fog, confusion, memory loss, food intolerances and allergies, chronic gas and bloating, migraine headaches, shortness of breath, chest pain, irregular heartbeat, ringing in ears (tinnitus), vision changes, insomnia and irregular sleep patterns, depression and anxiety, changes in taste and smell, cold and heat sensitivities, enlarged thyroid, dry flaky skin, oral thrush, itchy anus, foul armpit odor, slow wound healing, thickening of facial hair, nasal infection, kidney stones, and staph infection.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain fog, Chest pain, Colonoscopy, Confusional state, Depression
Clinical narrative: The day after the first dose of COVID mRNA vaccination I began feeling extremely fatigued, followed by brain fog, confusion, memory loss, food intolerances and allergies, chronic gas and bloating, migraine headaches, shortness of breath, chest pain, irregular heartbeat, ringing in ears (tinnitus), vision changes, insomnia and irregular sleep patterns, depression and anxiety, changes in taste and smell, cold and heat sensitivities, enlarged thyroid, dry flaky skin, oral thrush, itchy anus, foul armpit odor, slow wound healing, thickening of facial hair, nasal infection, kidney stones, and staph infection.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dry skin, Dyspnoea, Electrocardiogram, Endoscopy, Fatigue
Clinical narrative: The day after the first dose of COVID mRNA vaccination I began feeling extremely fatigued, followed by brain fog, confusion, memory loss, food intolerances and allergies, chronic gas and bloating, migraine headaches, shortness of breath, chest pain, irregular heartbeat, ringing in ears (tinnitus), vision changes, insomnia and irregular sleep patterns, depression and anxiety, changes in taste and smell, cold and heat sensitivities, enlarged thyroid, dry flaky skin, oral thrush, itchy anus, foul armpit odor, slow wound healing, thickening of facial hair, nasal infection, kidney stones, and staph infection.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flatulence, Food allergy, Food intolerance, Goitre, Hair growth abnormal
Clinical narrative: The day after the first dose of COVID mRNA vaccination I began feeling extremely fatigued, followed by brain fog, confusion, memory loss, food intolerances and allergies, chronic gas and bloating, migraine headaches, shortness of breath, chest pain, irregular heartbeat, ringing in ears (tinnitus), vision changes, insomnia and irregular sleep patterns, depression and anxiety, changes in taste and smell, cold and heat sensitivities, enlarged thyroid, dry flaky skin, oral thrush, itchy anus, foul armpit odor, slow wound healing, thickening of facial hair, nasal infection, kidney stones, and staph infection.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate irregular, Hydrogen breath test, Impaired healing, Infection, Insomnia
Clinical narrative: The day after the first dose of COVID mRNA vaccination I began feeling extremely fatigued, followed by brain fog, confusion, memory loss, food intolerances and allergies, chronic gas and bloating, migraine headaches, shortness of breath, chest pain, irregular heartbeat, ringing in ears (tinnitus), vision changes, insomnia and irregular sleep patterns, depression and anxiety, changes in taste and smell, cold and heat sensitivities, enlarged thyroid, dry flaky skin, oral thrush, itchy anus, foul armpit odor, slow wound healing, thickening of facial hair, nasal infection, kidney stones, and staph infection.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mast cell activation syndrome, Migraine, Nephrolithiasis, Oral candidiasis, Parosmia
Clinical narrative: The day after the first dose of COVID mRNA vaccination I began feeling extremely fatigued, followed by brain fog, confusion, memory loss, food intolerances and allergies, chronic gas and bloating, migraine headaches, shortness of breath, chest pain, irregular heartbeat, ringing in ears (tinnitus), vision changes, insomnia and irregular sleep patterns, depression and anxiety, changes in taste and smell, cold and heat sensitivities, enlarged thyroid, dry flaky skin, oral thrush, itchy anus, foul armpit odor, slow wound healing, thickening of facial hair, nasal infection, kidney stones, and staph infection.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Skin exfoliation, Skin odour abnormal, Sleep disorder, Staphylococcal infection
Clinical narrative: The day after the first dose of COVID mRNA vaccination I began feeling extremely fatigued, followed by brain fog, confusion, memory loss, food intolerances and allergies, chronic gas and bloating, migraine headaches, shortness of breath, chest pain, irregular heartbeat, ringing in ears (tinnitus), vision changes, insomnia and irregular sleep patterns, depression and anxiety, changes in taste and smell, cold and heat sensitivities, enlarged thyroid, dry flaky skin, oral thrush, itchy anus, foul armpit odor, slow wound healing, thickening of facial hair, nasal infection, kidney stones, and staph infection.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Stool analysis, Taste disorder, Temperature intolerance, Tinnitus, Ultrasound abdomen
Clinical narrative: The day after the first dose of COVID mRNA vaccination I began feeling extremely fatigued, followed by brain fog, confusion, memory loss, food intolerances and allergies, chronic gas and bloating, migraine headaches, shortness of breath, chest pain, irregular heartbeat, ringing in ears (tinnitus), vision changes, insomnia and irregular sleep patterns, depression and anxiety, changes in taste and smell, cold and heat sensitivities, enlarged thyroid, dry flaky skin, oral thrush, itchy anus, foul armpit odor, slow wound healing, thickening of facial hair, nasal infection, kidney stones, and staph infection.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound thyroid, Urine analysis, Urine organic acid test, Visual impairment
Clinical narrative: The day after the first dose of COVID mRNA vaccination I began feeling extremely fatigued, followed by brain fog, confusion, memory loss, food intolerances and allergies, chronic gas and bloating, migraine headaches, shortness of breath, chest pain, irregular heartbeat, ringing in ears (tinnitus), vision changes, insomnia and irregular sleep patterns, depression and anxiety, changes in taste and smell, cold and heat sensitivities, enlarged thyroid, dry flaky skin, oral thrush, itchy anus, foul armpit odor, slow wound healing, thickening of facial hair, nasal infection, kidney stones, and staph infection.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Inflammation, Injection site pain, Pain, Tendon disorder
Clinical narrative: Significant pain at injection on 4/29/21, pain and inflamation in shoulder that did not subside. After about two months of continued pain, I went to an orthopedic doctor and on 6/21/21 was evaluated and referred to physical therapy. Completed six weeks of physical therapy, which helped but did not eliminate pain. Ice, antiinflammatory medication, rest, and gentle exercise helped over last three years but the injury has not healed. Sharp, throbbing pain after any exercise or vigorous activity (such as cleaning), lasting for hours, continues. Returned to primary care doctor in January of 2024 and was again referred to 6 weeks physical therapy. Completed pt course (and continuing with it), but pain remains.
Age: 36.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Pt walked into clinic on 4/9 with rash development on R arm. Pt did not notice it until husband said something that day. Reports radiating pain in arm and itchiness. Circled rash. Provider inspected arm and informed pt if rash gets bigger, develop SOB/difficulty breathing, swollen tongue, to seek immediate care.
Age: 24.0
Sex: F
Vaccine: PNC20
Symptoms: Death, Respiratory distress
Clinical narrative: She had severe respiratory distress starting at 10pm on 4/8/24 (the day she was vaccinated) and then died at around 1130pm (she was declared at 0200 on 4/19/24 by a medical examiner)
Age: 47.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: local arm swelling, redness, induration for 1 week
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: pts arm got very red and swollen getting worse not better
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Headache, Influenza virus test negative, Nasal congestion, Pain
Clinical narrative: Same evening as vaccine, patient reported high fever, shaking chills, body aches, congestion, headaches and left arm.  At office visit next day patient had fever of 101.3, Pulse 109.  Nasal congestion and left arm tenderness without focal findings of redness, swelling, induration.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Same evening as vaccine, patient reported high fever, shaking chills, body aches, congestion, headaches and left arm.  At office visit next day patient had fever of 101.3, Pulse 109.  Nasal congestion and left arm tenderness without focal findings of redness, swelling, induration.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient received unknown brand of Covid vaccine at pharmacy and had immediate itching, redness at injection site.  Patient given benadryl and advised to go to ER.  Patient presented to our facility, was given diphenhydramine 25mg IV, famotidine 40mg IV, and methylprednisolone 125mg IV with improvement of symptoms.  Discharged home with prednisone taper and instructions to take diphenhydramine orally OTC.
Age: 42.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus
Clinical narrative: Pt almost immediately post injection developed pruritis.  No rash, no wheezing, no SOA
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site pain, Transient ischaemic attack
Clinical narrative: TIA 2 days later and erythema and injection site pain 9days later
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Rash, Rash erythematous, Skin burning sensation
Clinical narrative: On 4/10/2024 11:30am - Mother phoned to report that the patient "broke out in a rash (mostly on her legs but a few spots on her hands and neck) that was flat, red & kind of looked like a poison ivy like rash .  She complained of the burning red rash about 4 hours after receiving her vaccine.  I gave her Benadryl and that helped."   This morning the rash, redness and burning sensation is gone.  "She did have some nausea but she is also on her period."
Age: 68.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dyspnoea, Palpitations, Urticaria
Clinical narrative: Patient received both vaccines on 10-10-2023 in the right arm. When she came in for a covid booster on 4-10-2024, she informed me that 48 hours after receiving vaccines back in October, she broke out in hives all over her body and her heart was racing. She also said she started having a hard time breathing. Before going to the emergency room, she decided to take a benadryl. She said that her symptoms started to go away and she did not end up going to the emergency room.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Computerised tomogram head, Computerised tomogram neck, Computerised tomogram normal, Electrocardiogram normal
Clinical narrative: Emergency room 4 times 5/29/23. mild synovitis. lost of speech.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Synovitis
Clinical narrative: Emergency room 4 times 5/29/23. mild synovitis. lost of speech.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Electric shock sensation, Fatigue, Gastrointestinal disorder
Clinical narrative: At 1:00am the next morning I had joint pains, headache, fatigue, stomach issue from that point until mid June I had a very hard time digesting food. Mid June a doctor who had been seeing me said try to go off the Metformin for a week and see if that helps. I started helping within 24 hrs. I also from that point had different leg muscles  that will cramp up in the night sometimes both legs at the same time. From that shot on if I'm out in the cold  for 15  minutes or more when I come in my legs from my knees to my hips feel like they are being electrocuted. This can last for over 10 minutes.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Laboratory test, Muscle spasms, Nerve conduction studies, Temperature intolerance
Clinical narrative: At 1:00am the next morning I had joint pains, headache, fatigue, stomach issue from that point until mid June I had a very hard time digesting food. Mid June a doctor who had been seeing me said try to go off the Metformin for a week and see if that helps. I started helping within 24 hrs. I also from that point had different leg muscles  that will cramp up in the night sometimes both legs at the same time. From that shot on if I'm out in the cold  for 15  minutes or more when I come in my legs from my knees to my hips feel like they are being electrocuted. This can last for over 10 minutes.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Pain in extremity
Clinical narrative: Sore arm, balance issues, dizziness, light headed
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received catch-up schedule of vaccines despite having already received up-to-date vaccines in state from birth. Received 8 DTaPs with the 8th (5th in catch-up) given 1 month early which started this investigation, as it was counted as an inadvertent dose yet the parent had been advised that giving "it early was ok". Parent to connect with PCP, Dr., regarding discussion of number of vaccines. As of 4/2/24 no adverse s/s noted.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Swelling
Clinical narrative: Pt had some swelling
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB, RV1
Symptoms: Crying, Injection site swelling
Clinical narrative: Patient recieved vaccines on 3/1/2024 ordered by FNP-BC and returned to clinic 4/3/2024 for follow up appointment scheduled for well child check with MD. At the visit patient mother reported to have had crying for one hour and it was relieved by tylenol at home. The next day patient was crawling well. 2 days after on 2/23/2024 mother noticed bump on her right thigh at site of vaxelis that lasted total 5 dyas and resolved.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions. Child was given vaccine and did not need it at this time.
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue
Clinical narrative: 12 hours after injection, extreme chills for 9 hours.. extreme fatigue, similar, not as long, for  the next day.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: Tinnitus, chronic fatigue.  Constant ringing in ears and unabating fatigue.  Continues until now.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Amnesia, Dyskinesia, Feeling abnormal, Syncope
Clinical narrative: Guardian reported that after the vaccine in the office on the way home patient had syncope episode and had 3 jerking movements with his arms and then came back. Episode was similar to a previous event when he had Covid about 4 months ago and at that time he had a fever. Patient had a follow-up appointment 04/10/24 and is now reporting memory loss and not feeling himself.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Palpitations
Clinical narrative: Patient received second dose of vaccine with no issue. Upon walking around the store patient became light headed and reported heart racing. Her BP reading showed a pulse of 172. The patient relaxed and sat down for another 5 minutes at which point her pulse dropped to 105 and she reported feeling better.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Insomnia, Irritability, Pallor, Productive cough, Rash
Clinical narrative: Red rash to face, chest, abdomen and back that started 04/08/24 at night.  No fevers. Positive moist cough, runny nose. At night she was very fussy and unable to sleep, but not scratching at her rash. No new foods, drinks, soaps, lotions, reams, detergents. Impression blanching erythematous maculopapular rash that is confluent to face and trunk, stops at waist line. Spares palms and soles. Pt has appt 04/12/24.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous, Rash maculo-papular, Rhinorrhoea
Clinical narrative: Red rash to face, chest, abdomen and back that started 04/08/24 at night.  No fevers. Positive moist cough, runny nose. At night she was very fussy and unable to sleep, but not scratching at her rash. No new foods, drinks, soaps, lotions, reams, detergents. Impression blanching erythematous maculopapular rash that is confluent to face and trunk, stops at waist line. Spares palms and soles. Pt has appt 04/12/24.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: The patient was given only the diluent for the Hiberix vaccine. The diluent was not mixed with the powder. The lot number listed above was the lot number on the diluent syringe.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Immediate post-injection reaction, Loss of consciousness, Presyncope
Clinical narrative: Pt has PMH  Vasovagal reaction to vaccinations - She received Covid-19(Pfizer) and Typhim Vi in the Right Deltoid w/o Reaction.  Immediately after administering YF-VAX SC in Left arm she lost consciousness for 20 -25 seconds.   With her parent's assistance we gently moved her from the chair to the floor lying on her back and elevated her legs and cold pack to back of her neck.   She almost immediately came to and could speak - told us she was instantly dreaming of music after 7 - 10 minute we were able to move her back to chair.  She consumed water and juice and sat for 15 minutes before she was escorted to her car.  The parent was driving.  Patient was awake, alert and felt comfortable leaving on her own.  Parent was medical professional and was fine taking her home.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Hives all over the body, sore throat, difficulty breathing, headache, dizziness, and fatigue. The hospital stopped the rabies vaccine treatment and gave me steroids and Benadryl. The adverse reaction cleared up by day 3 of taking the steroids.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Hives all over the body, sore throat, difficulty breathing, headache, dizziness, and fatigue. The hospital stopped the rabies vaccine treatment and gave me steroids and Benadryl. The adverse reaction cleared up by day 3 of taking the steroids.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Condition aggravated, Sjogren's syndrome
Clinical narrative: The patient stated about 1.5 hours after vaccination her Sjorgen's flared, caused severe joint pain for 4 to 5 days.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Hard bump, itchy skin, and red inflamed area
Age: 44.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: Bell palsy on the left side of the face. It is effect my eating and I am not able move the left side of my face. It is affecting my speech.
Age: 44.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Neurological examination, Speech disorder, X-ray
Clinical narrative: Bell palsy on the left side of the face. It is effect my eating and I am not able move the left side of my face. It is affecting my speech.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Patient developed swelling and hives. Complained of itching. Gave Benadryl in clinic. Monitored for 30 minutes.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient expired 4/9/2024.
Age: 35.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Cough, Dizziness, Fatigue
Clinical narrative: Patient visited PCP on 11/10/2023 for schizophrenia f/u, administered Flu shot and Covid shot on same day. PCP received notification that patient went to ER on 11/15/2023 due to dizzy, cough and fatigue after covid/flu vaccines. Patient discharged from ER on same day.  Nurse from PCP office tried to f/u with patient, unable to obtain information.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccinations at well child visit on 3/26/2024. After patient and family left, nurse noticed that Hib vaccine expired the day prior on 3/25/2024. Ordering APRN and her supervising physician notified. Clinical Pharmacist notified. Patient's mother notified. Patients mother and patient's PCP spoke on the telephone. No obvious symptoms from this. Patient did come back in to clinic and received Hib vaccine that was not expired.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Bexsero Injection given 4/4/24 symptoms reported 4/5/24. Site painful, hard and 5x7 redness larger than 2 inches.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Confusional state, Pyrexia, Urticaria
Clinical narrative: High fever (104.8), hives over body, confusion
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Atrial fibrillation, Cardiac monitoring, Chest discomfort, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: On 04/05/2024 patient administered in hospital MMR vaccine.  RN noticed after vaccine administered to patient that it was expired on January 25th 2024 and disclosed to patient. Next day 04/05/2024 in the morning, patient complained of chest pressure and palpitaions only at rest. HR between 160 -170. EKG performed which demonstrated Atrial Fibrillation, patient transferred to Cardiac monitored unit and started on diltiazem drip and enoxaparin DVT prophylaxis then switched to oral therapy with diltiazem XR and metoprolol initially immediate release and then to extended release. Patient discharged on nifedipine extended release and metoprolol extended release
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, Metabolic function test, Palpitations
Clinical narrative: On 04/05/2024 patient administered in hospital MMR vaccine.  RN noticed after vaccine administered to patient that it was expired on January 25th 2024 and disclosed to patient. Next day 04/05/2024 in the morning, patient complained of chest pressure and palpitaions only at rest. HR between 160 -170. EKG performed which demonstrated Atrial Fibrillation, patient transferred to Cardiac monitored unit and started on diltiazem drip and enoxaparin DVT prophylaxis then switched to oral therapy with diltiazem XR and metoprolol initially immediate release and then to extended release. Patient discharged on nifedipine extended release and metoprolol extended release
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient age 14 years old, received ProQuad (MMRV). Patient is outside of age for ProQuad. I was to administer Varicella and MMR seperately.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dysphonia, Electrocardiogram abnormal, Epstein-Barr virus infection reactivation, Fatigue, Full blood count abnormal
Clinical narrative: After 7 COVID Vaccines, he has abnormal EKG, severe fatigue, reactivated EBV, Hoarseness in voice,gone from independently active to unable to walk w/o a walker, shuffling, abnormal CBC elevated WBC, acanthocytes
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Gait disturbance, Loss of personal independence in daily activities, Red blood cell acanthocytes present, Walking aid user, White blood cell count increased
Clinical narrative: After 7 COVID Vaccines, he has abnormal EKG, severe fatigue, reactivated EBV, Hoarseness in voice,gone from independently active to unable to walk w/o a walker, shuffling, abnormal CBC elevated WBC, acanthocytes
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Erythema, Fatigue, Pain in extremity, Peripheral swelling, Vaccination error
Clinical narrative: Pt received an erroneous dose of Hepatitis A. Pt parent reports pt complaining of arm soreness, redness and swelling. Patient has increase fatigue since immunization administration.
Age: 28.0
Sex: M
Vaccine: RAB
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Donor reports after receiving last donation that his right arm became red, swollen, and painful to the touch for approximately a day and half.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Pt had previously received an RSV (Arexvy) dose on 2/16/24. Due to an error in documentation (was documented as Shingrix instead), pt received a second RSV (Arexvy) dose on 4/9/24. Documentation was corrected and nursing home and provider will be notified.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Throat irritation
Clinical narrative: P c/o tongue swelling 45-75 min after receiving vaccine. no local reaction. Did not seek care or medicate. c/o continued feeling of tongue swelling, fullness x 7 weeks post vaccine. also throat irritation during  those weeks.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Pruritus
Clinical narrative: Patient RTC approx 4 hours post vaccination with red, swollen injection site including 4 inches above at the shoulder. Pt. is flushed in the face, BP wnl, reports itching, and arm feels stiff.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Diarrhoea, Muscle spasms, Nausea, Pyrexia
Clinical narrative: Hives, vomiting, nausea, diarrhea, fever, chills, uncontrolled muscle spasms
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria, Vomiting
Clinical narrative: Hives, vomiting, nausea, diarrhea, fever, chills, uncontrolled muscle spasms
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Limb discomfort
Clinical narrative: rash/ large red area at injection site that developed 5 days after pt was immunized. pt stated on 4/9 she had itching and an uncomfortable sensation in that area of the arm almost felt like a sunburn. patient presented to the pharmacy on 4/10 the area was red and slightly swollen and approximately 6 inches by 4 inches in size. pt is taking  ibuprofen and applying a cool compress and watching  for any changes and if the symptoms get worse will go to the dr.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Immunisation reaction, Sudden death
Clinical narrative: Sudden death; This spontaneous report was received from a physician refers to a 16-year-old male patient.  The patient's medical history included asthma. Concomitant therapies included salbutamol (ALBUTEROL [SALBUTAMOL]). The patient's concurrent conditions were not reported.  On 23-MAY-2013, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), formulation: intramuscular injection, lot # H016238, expiration date: 11-APR-2015, intramuscular in the left arm for prophylaxis (exact dose was not provided).  On 04-JUL-2013, the patient experienced sudden death. It was reported that the patient was perfectly healthy. Everything else in his life was normal, the same. The cause of death was reported as immunization (reported as: This vaccination is the only thing I can think of that would have caused this). Information about autopsy was unknown.   The reporter considered sudden death to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (reported as: This vaccination is the only thing I can think of that would have caused this).; Reported Cause(s) of Death: vaccination
Sex: U
Vaccine: HPV9
Symptoms: Transient ischaemic attack
Clinical narrative: HCP reported a patient has been experiencing mini strokes over the past month.; This spontaneous report was received from a nurse prescriber via company representative and refers to a 42-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in March 2024 (also reported as over the past month), the patient had been experiencing mini strokes. At the time of reporting, the outcome of the event was unknown.   The causal relationship between mini strokes and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was provided.  Upon internal review, the event mini strokes was determined to be medically significant.  Lot # is being requested and will be submitted if received.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No ae; some products experienced multiple TEs; This spontaneous report has been received from a nurse practitioner and refers to a 14-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 30-OCT-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (valid lot number: 1957405 [expiration date 11-NOV-2025]) (dose, dose number, frequency, vaccination scheme, and anatomical location were not provided), after temperature excursion.  No additional adverse event.  This is one of several reports from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; Caller reported AE for improperly stored administered MMR-II. No symptoms reported. Obtained consent to contact HCP. TE Filed (Case #02580758). No additional AE/PQC. Product Name: MMR-II (Lot: W019422 Exp: 6/20/2024) Temperature / Duration: 56.8F for; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant mdications was provided.  On 05-APR-2024 the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA) lot # W019422 and expiration date 20-JUN-2024, 0.5 milliliter for prophylaxis (dose number, route and expiration date were not provided). The Temperature excursion length was 1 Hour 40 Minutes 0 Seconds in temperature of 56.8 degrees Fahrenheit (F) (product storage error and no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Pyrexia, Rheumatoid arthritis
Clinical narrative: RA; CIDP; Fever 101; This serious case was reported by a consumer and described the occurrence of rheumatoid arthritis in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus. Concomitant products included hydroxychloroquine sulfate (Plaquenil).   On 02-APR-2024, the patient received Shingrix 50 ug. In APR-2024, an unknown time after receiving Shingrix, the patient experienced rheumatoid arthritis (Verbatim: RA) (serious criteria GSK medically significant), chronic inflammatory demyelinating polyradiculoneuropathy (Verbatim: CIDP) (serious criteria GSK medically significant) and fever (Verbatim: Fever 101). The outcome of the rheumatoid arthritis and chronic inflammatory demyelinating polyradiculoneuropathy were not reported and the outcome of the fever was not resolved.   It was unknown if the reporter considered the rheumatoid arthritis, chronic inflammatory demyelinating polyradiculoneuropathy and fever to be related to Shingrix.     It was unknown if the company considered the rheumatoid arthritis, chronic inflammatory demyelinating polyradiculoneuropathy and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-APR-2024 The reporter was a patient. The patient had a Shingrix vaccine and experienced fever 101, chronic inflammatory demyelinating polyradiculoneuropathy and rheumatoid arthritis. Patient had lupus syndrome and for that she receives plaquenil. The reporter reported that the symptoms were not treated. The reporter requested to consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient accidentally had a third Shingrix shot; This non-serious case was reported by a physician via sales rep and described the occurrence of extra dose administered in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On 21-MAR-2024, the patient received the 3rd dose of Shingrix (unknown arm). On 21-MAR-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient accidentally had a third Shingrix shot). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-MAR-2024 The reporter mentioned that a patient completed Shingrix series at office. The patient accidently received third dose of Shingrix at a pharmacy, which led to extra dose administered.
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Adult male, over 40 years old, was mistakenly administered Havrix instead of the intended Twinrix; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a adult male patient who received HAV (Havrix 1440 adult) for prophylaxis.   On 02-NOV-2023, the patient received the 1st dose of Havrix 1440 adult. On 02-NOV-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced wrong vaccine administered (Verbatim: Adult male, over 40 years old, was mistakenly administered Havrix instead of the intended Twinrix). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 05-APR-2024 This report was submitted via the online direct entry reporting system.  The patient over 40 years old, was mistakenly administered Havrix instead of the intended Twinrix, which led to wrong vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The patient was treated with valaciclovir (Valacyclovir). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-APR-2024 This case was reported by a patient via interactive digital media. The patient reported that he/she got the Shingrix vaccine. On Thursday he/she got the Shingles. The reporter stated that all literature said impossible only two other people in history. But today on 04-MAR-2024 (on the day of reporting) his/her physician put him/her on valacyclovir for a week because she was 90 percent sure it was Shingles. The patient never had it before. Ever. Until he/she got the shot. The patient not anti-vax but he/she mad, and he/she would not be getting the second shot.
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Computerised tomogram abnormal, Inflammation, Malaise
Clinical narrative: patient felt rough; inflammation; This non-serious case was reported by a consumer via call center representative and described the occurrence of roughness circumoral in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included heart disorder (has a heart patient).   On 18-MAR-2024, the patient received Arexvy (left arm). In MAR-2024, less than a day after receiving Arexvy, the patient experienced roughness circumoral (Verbatim: patient felt rough) and inflammation (Verbatim: inflammation). The outcome of the roughness circumoral and inflammation were unknown.   It was unknown if the reporter considered the roughness circumoral and inflammation to be related to Arexvy.     It was unknown if the company considered the roughness circumoral and inflammation to be related to Arexvy.   Additional Information: GSK receipt date: 26-MAR-2024 The reporter reported that he received a RSV vaccine on 18th March 2024 and experienced felt rough Monday night, all day Tuesday 19th March 2024, and Wednesday 20th March 2024. The patient was unable to confirm if he received the Pfizer RSV vaccine or Arexvy. The lot number and expiry date were not available to verify the product. The patient also reports that he received a CT scan on Wednesday morning, 20-MAR-2024, and it shows some inflammation. The patient reports he was a heart patient. The reporter requested to consent the follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15-FEB-2023).   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: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 26-MAR-2024 A pharmacist reported that a patient who received their first dose of Shingrix and had not received their second dose yet and it had been over year. The reporter wanted to know how long to wait to get the second dose, did patient had to start over on the Shingrix series. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024038681:Different patient US-GSK-US2024038678:Different patient US-GSK-US2024038680:Different patient US-GSK-US2024038679:Different patient
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Vomiting
Clinical narrative: severe pain in the abdomen like muscle spasms; stomach upset; vomiting; This non-serious case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2023, the patient received the 1st dose of Shingrix (right arm). In NOV-2023, less than a day after receiving Shingrix, the patient experienced abdominal pain (Verbatim: severe pain in the abdomen like muscle spasms), upset stomach (Verbatim: stomach upset) and vomiting (Verbatim: vomiting). The outcome of the abdominal pain, upset stomach and vomiting were resolved (duration 3 days).   It was unknown if the reporter considered the abdominal pain, upset stomach and vomiting to be related to Shingrix.     It was unknown if the company considered the abdominal pain, upset stomach and vomiting to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAR-2024 The patient self reported the case. The patient reported that she received the Shingrix vaccine and experienced the vomiting, stomach upset and sever abdominal pain like muscle spasms in evening (on the day of vaccination). The patient did not feel comfortable providing any further information. The reporter requested to consent the follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: experienced pain/ pain at injection site; swelling at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-MAR-2024, the patient received the 1st dose of Shingrix. In MAR-2024, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: experienced pain/ pain at injection site) and injection site swelling (Verbatim: swelling at injection site). The outcome of the injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.     It was unknown if the company considered the injection site pain and injection site swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-MAR-2024 The reporter was the husband of the patient. The patient had her first dose of Shingrix and experienced pain and swelling at injection site.  No further information was known.  The reporter consented to follow up. This US2024039359 case has been linked to the case reported by the same reporter.; Sender's Comments:  US-GSK-US2024039359:Same reporter
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: pain at the injection site; pain especially with movement/aching pain without movement/radiating pain/pins and needle pain; pain sometimes radiates to her neck; pain sometimes radiates down her arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In DEC-2023, the patient received Arexvy (unknown arm). In DEC-2023, 1 day after receiving Arexvy, the patient experienced injection site pain (Verbatim: pain at the injection site), pain (Verbatim: pain especially with movement/aching pain without movement/radiating pain/pins and needle pain), neck pain (Verbatim: pain sometimes radiates to her neck) and pain in arm (Verbatim: pain sometimes radiates down her arm). The outcome of the injection site pain, pain, neck pain and pain in arm were not resolved.   It was unknown if the reporter considered the injection site pain, pain, neck pain and pain in arm to be related to Arexvy.     It was unknown if the company considered the injection site pain, pain, neck pain and pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-MAR-2024 The patient self reported this case. The patient received her Arexvy vaccine near the end of December 2023. The day after the vaccination she began experiencing pain at the injection site that sometimes radiates down her arm and up her arm to her neck, especially with movement. The patient also had aching pain without movement. This pain was still with patient today (on the day of reporting), 3 months later. The patient also reported experiencing pins and needles pains in her arm that lasted for 2 months.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of cellulitis in a finite number of patients 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 cellulitis (Verbatim: Cellulitis). The outcome of the cellulitis was unknown.   It was unknown if the reporter considered the cellulitis to be related to Shingrix.   It was unknown if the company considered the cellulitis to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-MAR-2024 The pharmacist had 2 patients who developed cellulitis after Shingrix (unknown dose number).; Sender's Comments:  US-GSK-US2019170912:Same reporter / different patient
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: the administration of a third dose of Shingrix to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date ) and Shingrix (2nd dose received on an unknown date ).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: the administration of a third dose of Shingrix to a patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-MAR-2024 A healthcare professional contacted GlaxoSmithKline to request data about the administration of a third dose of Shingrix to a patient that was unsure of finishing the previous series, which led to extra dose administered. They did not specify any details in reference to the patient and product.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: only administered the diluent component; only administered the diluent component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 7RK73, expiry date 07-DEC-2025) for prophylaxis.   On 04-APR-2024, the patient received Shingrix. On 04-APR-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: only administered the diluent component) and inappropriate preparation of medication (Verbatim: only administered the diluent component). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 04-APR-2024 Medical Assistant called to report that a 61 years old female patient received today a Shingrix shot but they only administered the diluent component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.