chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Blood glucose, Presyncope, Syncope
Clinical narrative: Patient is a 18 year old female who presented for her well child visit on 01/16/2024. Prior to the vaccinations, patient exhibited nervous behavior.  Patient received four vaccinations during her visit. Patient received her second dose of HPV, first dose of Meningococcal B (Trumenba), second dose of Menactra and second dose Influenza. After her last two vaccines were given in her left deltoid, patient began to lean forward from the exam table and she collasped onto the floor. After recovering from her near fainting incident, patient revealed to doctor that she had not eaten anything but fruit since the am. Patient did not loose consciousness during the episode. Patient was examined by the doctor after her incident. She underwent several  tests and blood pressure checks to ensure patient's well being. EMT/Ambulance service was called for further investigation. Patient was able to be discharged from office in stable condition.  Patient had a follow up visit to PCP office for follow up
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test positive
Clinical narrative: Adverse Outcome: Hyperantibody response that has been continuos.  No boosters have been received and I have never tested positive for Covid since receiving any vaccinations yet anti body level has gone up every six months starting at 989 U/ml six months after the first dose to GREATER than 25,000 U/ml thirty months after the vaccine meaning my antibody level is beyond the limits of the test range
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccines was frozen and no refrigerated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was given child vaccine instead of adult vaccine. Which is a smaller does patient was given 2.5 dosage of Moderna Covid 19 vaccine she needs .5 in order for it to be completed.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Pt reports shoulder pain that started the day after receiving the vaccine. She was unable to lift her arm for several weeks. She has started to see improvement. Pt has yet to see her PCP regarding the issue but has an appointment scheduled for 2/1
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen and not refrigerated.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test negative, Biopsy skin normal, Blood test normal, Rash
Clinical narrative: Started to have rashes appear all over my body.  Have been going to the dermatologist for a year and no cause has been found.  Did bloodwork and a biopsy on the affected skin, and allergy testing.  All came back with out anything conclusive.  Not allergiallergic to anything, nor could they describe specifically what my issue was.  Rashes start spreading all over both my right and left arm covering my entire upper arm.  The rashes eventually start to weep fluid and continue to spread.  Steroids have slowed it down, but only in the short term with it reappearing again and again.  No changes in my habits, diet, sleep, or anything of that nature.  Now rashes are spreading all over my body.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test positive, Autoimmune disorder, Dizziness postural, Fatigue, Postural orthostatic tachycardia syndrome
Clinical narrative: Fatigue which worsened over time. Around mid March 2021 I remember becoming dizzy upon standing but don't remember a specific date. On 3/27/2021 I had my first every syncope episode. On 6/30/2023 I was diagnosed with POTS and I can trace the origin of this to March 2021.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative, Syncope, Tilt table test positive
Clinical narrative: Fatigue which worsened over time. Around mid March 2021 I remember becoming dizzy upon standing but don't remember a specific date. On 3/27/2021 I had my first every syncope episode. On 6/30/2023 I was diagnosed with POTS and I can trace the origin of this to March 2021.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration, Vitiligo
Clinical narrative: Within a few days of receiving the Pfizer COVID-19 vaccine, started to lose color in patches on face, arms, back, shoulders.  Skin discoloration is continuing to worsen.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Swelling face
Clinical narrative: facial swelling
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Left arm severe pain stated the next day of  vaccination. The pain from shoulder to elbow. It affected daily life,  lasted  3 weeks  already by now.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Breast cancer female, Oedema peripheral, Peripheral swelling
Clinical narrative: Arm pit swelling...underneath arm. Later developed  breast cancer.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymph nodes in left arm  with pain for about 2 weeks. Pain went away but swollen lymph nodes for about 12 week. Patient also had joint pain for 2 or 3 days.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Electrocardiogram abnormal, Supraventricular tachycardia
Clinical narrative: This was my 3rd Moderna booster shot after getting 2 Phizer shots. I started developing arrhythmia (atrial fibrillation, atrial flutter, and supraventricular tachychardia within 1 month after receiving the vaccine.
Age: 0.17
Sex: F
Vaccine: PNC20, RV1, VARCEL
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Varicella vaccine was given at 2 months of age in error, instead of Vaxelis vaccine.
Age: 17.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Gave vaccines as first-time vaccines per FDA catch-up schedule for patient here from another country (part of student exchange program). However, patient's sponsor called back and let us know he actually received the same vaccines on the following dates: Havrix (Hep A)-12/20/23 & Varivax (Varicella)-11/30/23.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Vaccine administration error - extra dose received. Patient received Gardasil vaccine based on initial verbal history. Subsequent verbal history indicated that patient had already previously received 3-dose series. Due to vaccines given in another state, vaccine history was not available. No signs/symptoms demonstrated after immunization.  Patient observed for 60 minutes after administration.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen and no refrigerated.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Fatigue, Injection site erythema, Pain
Clinical narrative: Uncontrollable shaking, extreme aching throughout body, chills (but no fever), fatigue, feeling faint, chest pains, lower pelvic pains. Shaking lasted about 12 hours, other symptoms for 4-5 days. Today (6th day) still feel fatigued, but better. Bright red skin on left arm around injection point, extending 2/3 length of upper arm between shoulder and elbow, and wrapping halfway around circumference of arm. Itchiness in same area. Continues today (6th day), but slowly abating.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pelvic pain, Syncope, Tremor
Clinical narrative: Uncontrollable shaking, extreme aching throughout body, chills (but no fever), fatigue, feeling faint, chest pains, lower pelvic pains. Shaking lasted about 12 hours, other symptoms for 4-5 days. Today (6th day) still feel fatigued, but better. Bright red skin on left arm around injection point, extending 2/3 length of upper arm between shoulder and elbow, and wrapping halfway around circumference of arm. Itchiness in same area. Continues today (6th day), but slowly abating.
Age: 1.42
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: C-reactive protein normal, Cough, Full blood count normal, Influenza virus test negative, Irritability
Clinical narrative: Pt. developed a rash beginning on his thighs and spreading to his abdomen then entire body, beginning a few hours after the vaccine. He also developed fever to 102 for 4 days and a cough but no fever.  He was very irritable and there was a concern that he could have Kawasaki disease
Age: 1.42
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Laboratory test normal, Pyrexia, Rash, Red blood cell sedimentation rate increased, SARS-CoV-2 test negative
Clinical narrative: Pt. developed a rash beginning on his thighs and spreading to his abdomen then entire body, beginning a few hours after the vaccine. He also developed fever to 102 for 4 days and a cough but no fever.  He was very irritable and there was a concern that he could have Kawasaki disease
Age: 1.42
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Streptococcus test negative
Clinical narrative: Pt. developed a rash beginning on his thighs and spreading to his abdomen then entire body, beginning a few hours after the vaccine. He also developed fever to 102 for 4 days and a cough but no fever.  He was very irritable and there was a concern that he could have Kawasaki disease
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Injection site rash, Irritability, Pyrexia
Clinical narrative: Onset rash left upper thigh 5 days ago - near injection site, slowly resolving.  Also had red mark on right thigh on day of vaccines, resolved within 48 hours.  Developed low grade fever last night.  Fussy with sleep last night.  No congestion, rhinorrhea, cough.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Nausea, Rhinorrhoea, Sinus congestion
Clinical narrative: Roughly 24 hours after administration of vaccine patient describes feeling headache, sinus congestion, and runny nose, nausea.
Age: 2.0
Sex: F
Vaccine: FLUA4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: 5 days post vaccine, Vomiting, diarrhea sudden onset. no outings or exposure. In home care and parent care only.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was not frozen it was refrigerated.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis
Clinical narrative: Hospitalized and found to have bilateral PE and DVT. Treated with anticoagulant.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Dizziness, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Vaccine was administered below the deltoid muscle, resulting in cellulitis. Patient went to urgent care and was prescribed cephalexin 500 mg four times daily for 7 days.  Patient was also experiencing dizziness and joint pain along with redness and swelling at injection site.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine was administered below the deltoid muscle, resulting in cellulitis. Patient went to urgent care and was prescribed cephalexin 500 mg four times daily for 7 days.  Patient was also experiencing dizziness and joint pain along with redness and swelling at injection site.
Age: 5.0
Sex: F
Vaccine: FLU4, HEP, HEPA, MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient came in with family to get vaccinated. She, her brother, and sister were to get vaccinated at our vaccination event. she and her mother were waiting while her brother was getting vaccinated. I had called out (Redacted) which I later found out was her sister to get vaccination. Her mother had placed Patient on the chair, and we proceeded to vaccinate. After I had vaccinated Patient, her mother then questioned and informed me that this was Patient and not the sister. I then called our provider to inform the provider of the error. We informed the mother that her daughter would be safe from any adverse effects, and that we would have to get the right vaccinations at a later date. The mother verbalized understanding and agreed.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen and not refrigerated.
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Administration site erythema, Chills, Exposure during pregnancy, Injection site pain, Myalgia
Clinical narrative: Following vaccination, the patient began experiencing fever (max 102 degrees F), chills, myalgias and noted an erythematous patch developing around the site where the vaccine was administered. She endorsed significant pain at the site and relayed that the pain seemed to be creeping up her arm.
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Following vaccination, the patient began experiencing fever (max 102 degrees F), chills, myalgias and noted an erythematous patch developing around the site where the vaccine was administered. She endorsed significant pain at the site and relayed that the pain seemed to be creeping up her arm.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Seizure
Clinical narrative: hospitalized due to sz activities and found to have PE. Anticoag started.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site mass
Clinical narrative: 2 weeks post vaccination noticed a hard, marble sized lump at injection site. Notified Pediatric office and was told to "give Motrin."
Age: 16.0
Sex: F
Vaccine: FLUC4, HPV9, MENB, MNQ
Symptoms: Injection site rash, Injection site swelling, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: Pt received vaccines on 01.03.24 around 11am.  She went home and later that afternoon around 6pm noticed that both arms were itching, warm to touch and felt swollen.  The following morning she noticed continued itching with a golf ball size swollen area on her LEFT arm and a baseball sized swollen area on her RIGHT arm where injections were given.    She also noticed a small red rash on both arms around the injection sites.  Mom applied cool compresses and gave benadryl every 6 hours for 24 hours.  Patient was seen in the office on 01.09.24 and swollen areas at that time were resolved.
Age: 16.0
Sex: F
Vaccine: FLUC4, HPV9, MENB, MNQ
Symptoms: Skin warm
Clinical narrative: Pt received vaccines on 01.03.24 around 11am.  She went home and later that afternoon around 6pm noticed that both arms were itching, warm to touch and felt swollen.  The following morning she noticed continued itching with a golf ball size swollen area on her LEFT arm and a baseball sized swollen area on her RIGHT arm where injections were given.    She also noticed a small red rash on both arms around the injection sites.  Mom applied cool compresses and gave benadryl every 6 hours for 24 hours.  Patient was seen in the office on 01.09.24 and swollen areas at that time were resolved.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Malaise
Clinical narrative: feeling sick - heart ache
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: MENQUADI WAS ORDERED MA ADMINISTERED TRUMENBA
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Skin warm, Vaccination site bruising, Vaccination site erythema, Vaccination site vesicles
Clinical narrative: Patient presents to pharmacy 2 days after vaccination with open blister on arm were vaccine was given. States that the arm is warm to the touch. Arm is also red and bruised underneath the blister where the vaccine was given. Patient was given antibiotic ointment to put on open blister and a bandage to cover arm with.
Age: 75.0
Sex: F
Vaccine: HEPAB
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: Starting on December 3, 2023 elbow on left arm hurt and whole arm from shoulder to fingers felt discomfort with certain movements, such as arm outstretched or bending arm at elbow to lift pot.  Discomfort when walking with arm extended at side carrying something.  Some days very uncomfortable and painful, others less so, but always some discomfort.  Reported to primary care specialist, about 10 days after pain/discomfort started.  On January 5, 2024 reported adverse reaction to pharmacists and Pharmacy, as I was due for second shot in 3-shot series.  Pharmacy also filed a report with VAERS.  Symptoms can be alleviated with Tylenol, if severe.
Age: 18.0
Sex: M
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Reporting that the MMRV (Proquad) was administered outside the approved age range of 12months-12years.  Patient is 18 years of age.  No reported adverse reaction to the vaccine at this time.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Shortly after receiving the vaccine she developed some redness, swelling, pain, and itching around the injection site.  It has been there now for a week without getting any better.  Patient has not treated it with anything.  On 1/17/24 patient followed up and Dr. instructed her to use benadryl and can also apply ice or cool compresses to the area.  Patient had received prevnar 23 without incident in 2014.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: There was no adverse event. The child was given her initial covid vaccine on 12-13-23. When she came on 1-10-24 to get her booster it was discovered it was given incorrectly. Instead of the multidose vial being diluted and a single dose given, the child received 3doses of undiluted vaccine. Mother reported she had tolerated the vaccine without any complications/side effects on 12-13-23.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Biopsy, Biopsy lymph gland abnormal, Bone scan, Breast cancer female
Clinical narrative: Metastatic Her 2+,  something negative Breast Cancer Diagnosis July  2023. Self discovery of lump. Missed 1 mammogram between 2021 and 2023. Therefore do not know exactly when it started. Had yearly mammograms prior to then.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer metastatic, Breast mass, Chronic kidney disease, Gene mutation identification test negative, Hormone receptor positive breast cancer
Clinical narrative: Metastatic Her 2+,  something negative Breast Cancer Diagnosis July  2023. Self discovery of lump. Missed 1 mammogram between 2021 and 2023. Therefore do not know exactly when it started. Had yearly mammograms prior to then.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Immediate post-injection reaction, Lymphadenectomy, Magnetic resonance imaging, Mammogram
Clinical narrative: Metastatic Her 2+,  something negative Breast Cancer Diagnosis July  2023. Self discovery of lump. Missed 1 mammogram between 2021 and 2023. Therefore do not know exactly when it started. Had yearly mammograms prior to then.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal pruritus
Clinical narrative: Metastatic Her 2+,  something negative Breast Cancer Diagnosis July  2023. Self discovery of lump. Missed 1 mammogram between 2021 and 2023. Therefore do not know exactly when it started. Had yearly mammograms prior to then.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal cancer stage III
Clinical narrative: Rectal cancer stage 3c
Age: 1.33
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: There was no adverse event. Child was given an incorrect dose of covid vaccine. The covid vaccine was a 6mon-4years vaccine but it is a multidose vial. Child was given their initial vaccine on 12-13-23. When he came for his booster on 1-10-24 it was found that the vaccine is actually a multidose vial that is suppose to be diluted. Believed that child received all of the multidose vial (3doses) and it was not diluted.
Age: 57.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Vaccine administered Prior to age requirement (60+). Pt was 57y/o at time of administration. No adverse event. Provider notified of administration error. Pt  notified by provider.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient was seen for her four year well visit on 1/10/2024 where she received three vaccines. Quadracel, MMR, and Influenza. The patient started experiencing symptoms in her left thigh on the same afternoon. Symptoms were redness and site was hot to the touch. Mother gave the patient Benadryl. The patient then came in to seen for the vaccine reaction. He counseled the patient guardian about the vaccine reaction and what the medication to use if she continues to experience pain. A follow up was made for 2-3 days regarding this matter.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Mental impairment
Clinical narrative: Headache x 4 days, fatigue x 10 days, decreased mental acuity x 10 days.
Age: 71.0
Sex: M
Vaccine: PNC20
Symptoms: Contusion, Erythema, Skin warm
Clinical narrative: Patient describes erythema, heat, and bruising beginning approximately 24 hours following injection. Heat and erythema resolved within 24 hours, bruising continued through the following week.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Electrocardiogram, Eye swelling, Lacrimation increased, Tachycardia
Clinical narrative: about a week post RSV vaccine, experiencing Tachycardia through out the day. Puffy and watery eyes. Still continuing to have tachycardia intermittently throughout the day into the evening.
Age: 71.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Abdominal distension, Abdominal pain, Blood test normal, C-reactive protein normal, Chest X-ray abnormal
Clinical narrative: I gained 15+lbs in less than 2 weeks? time (up to 223 lbs.) along with elevated heart rate, abdominal bloating and pain, SOB, cough and extreme lethargy. This led me to my PCP who ordered bloodwork, abdominal and chest ultrasound and chest X-ray. US revealed fluid in abdomen and chest cavity. PCP referred me to cardiologist (first appt. Nov.2, 2023) who ordered echocardiogram, MRI, CT and bloodwork. His exam showed clear lungs, cardiac rub, thickening of pericardium and a diagnosis of Pericarditis. He began Prednisone 60mg qd, Colchicine 0.6mg qd, and Furosemide 20mg qd.  As of Jan. 10 Prednisone has been tapered to 10mg qd. Colchicine remains unchanged and Furosemide is MWF. Heart rate is lower, but still elevated.  Weight is stable ~205-207.
Age: 71.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Computerised tomogram abdomen abnormal, Cough, Dyspnoea, Electrocardiogram abnormal, Heart rate increased
Clinical narrative: I gained 15+lbs in less than 2 weeks? time (up to 223 lbs.) along with elevated heart rate, abdominal bloating and pain, SOB, cough and extreme lethargy. This led me to my PCP who ordered bloodwork, abdominal and chest ultrasound and chest X-ray. US revealed fluid in abdomen and chest cavity. PCP referred me to cardiologist (first appt. Nov.2, 2023) who ordered echocardiogram, MRI, CT and bloodwork. His exam showed clear lungs, cardiac rub, thickening of pericardium and a diagnosis of Pericarditis. He began Prednisone 60mg qd, Colchicine 0.6mg qd, and Furosemide 20mg qd.  As of Jan. 10 Prednisone has been tapered to 10mg qd. Colchicine remains unchanged and Furosemide is MWF. Heart rate is lower, but still elevated.  Weight is stable ~205-207.
Age: 71.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Intra-abdominal fluid collection, Lethargy, Magnetic resonance imaging, Pericardial effusion, Scan with contrast abnormal
Clinical narrative: I gained 15+lbs in less than 2 weeks? time (up to 223 lbs.) along with elevated heart rate, abdominal bloating and pain, SOB, cough and extreme lethargy. This led me to my PCP who ordered bloodwork, abdominal and chest ultrasound and chest X-ray. US revealed fluid in abdomen and chest cavity. PCP referred me to cardiologist (first appt. Nov.2, 2023) who ordered echocardiogram, MRI, CT and bloodwork. His exam showed clear lungs, cardiac rub, thickening of pericardium and a diagnosis of Pericarditis. He began Prednisone 60mg qd, Colchicine 0.6mg qd, and Furosemide 20mg qd.  As of Jan. 10 Prednisone has been tapered to 10mg qd. Colchicine remains unchanged and Furosemide is MWF. Heart rate is lower, but still elevated.  Weight is stable ~205-207.
Age: 71.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Ultrasound abdomen abnormal, Ultrasound chest
Clinical narrative: I gained 15+lbs in less than 2 weeks? time (up to 223 lbs.) along with elevated heart rate, abdominal bloating and pain, SOB, cough and extreme lethargy. This led me to my PCP who ordered bloodwork, abdominal and chest ultrasound and chest X-ray. US revealed fluid in abdomen and chest cavity. PCP referred me to cardiologist (first appt. Nov.2, 2023) who ordered echocardiogram, MRI, CT and bloodwork. His exam showed clear lungs, cardiac rub, thickening of pericardium and a diagnosis of Pericarditis. He began Prednisone 60mg qd, Colchicine 0.6mg qd, and Furosemide 20mg qd.  As of Jan. 10 Prednisone has been tapered to 10mg qd. Colchicine remains unchanged and Furosemide is MWF. Heart rate is lower, but still elevated.  Weight is stable ~205-207.
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Abrybo instead of Beyfortus. no symptoms.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Adverse events started  2hrs after getting vaccinated. Redness to injection site, swelling around injection site, warm/red around injection site, pain to right upper arm (mostly around injection site), with movement there is pain radiating down right arm.   Injection site hard to touch. Took ibuprofen for pain with no relieve to pain. Redness got bigger. Swelling did improve.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: Adverse events started  2hrs after getting vaccinated. Redness to injection site, swelling around injection site, warm/red around injection site, pain to right upper arm (mostly around injection site), with movement there is pain radiating down right arm.   Injection site hard to touch. Took ibuprofen for pain with no relieve to pain. Redness got bigger. Swelling did improve.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: PAIN AND SWELLING AT INJECTION SITE FOR 4 DAYS, THEN WENT AWAY. 8 DAYS LATER HAD RASH ALL OVER BODY (MORE PREVALENT ON LEFT ARM THAN RIGHT ARM). STARTED TREATMENT WITH TRIAMCINOLONE CREAM 3 WEEKS AGO AND SEEING IMPROVEMENT
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pt received the vaccine on 10/10/23 in the left deltoid and started experiencing pain in left arm after vaccination.  Initially, she had pain at the injection site and has limited range of motion. Due to continued pain on left arm that migrates to left shoulder and limited range of motion. Pt has sought treatment with her primary doctor since December and was referred to Orthopedic. Pt was told by an Orthopedic Doctor that the pain was due to vaccination being given too high and that pain takes 5-10 weeks to radiate to the left shoulder.  A steroid shot was given that helps with pain.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drowning, Internal haemorrhage, Pulmonary embolism, Respiratory disorder, Respiratory failure
Clinical narrative: after the 3rd injection, patient started having breathing problems. She drove herself to the emergency room and shortly after she was admitted. the Dr found a blood clot in her leg, another blood clot in her lung and a blood clot by her heart,  the Drs rushed her into emergency surgery to remove the 3 clots but the clot by her heart  stated bleeding and she drowned in her own blood.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombectomy, Thrombosis, Venous thrombosis
Clinical narrative: after the 3rd injection, patient started having breathing problems. She drove herself to the emergency room and shortly after she was admitted. the Dr found a blood clot in her leg, another blood clot in her lung and a blood clot by her heart,  the Drs rushed her into emergency surgery to remove the 3 clots but the clot by her heart  stated bleeding and she drowned in her own blood.
Age: 0.17
Sex: F
Vaccine: FLUC4, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administration error, given prior to recommended age.  No adverse reaction observed patent for > 60 minutes.
Age: 15.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: No adverse event
Clinical narrative: no side effect shown
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/no PQC.; Nurse called to report MMR II which expired on 12/16/2023 was inadvertently administered today on 12/19/2023.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 19-DEC-2023, the patient was inadvertently vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, lot #U039906, expiration date: 16-DEC-2023 (strength, dose, and route of administration were not provided) administered for prophylaxis (expired product administered). No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller reported patient received GARDASIL 9 in 2011, 2012, 2015.; no adverse event; This spontaneous report was received from a pharmacist and referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On an unknown date in 2011, 2012, and 2015, the patient was vaccinated with the first, second, and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, lot #, expiry date, dose, and route of administration were not provided), administered for prophylaxis, respectively (inappropriate schedule of product administration). No additional adverse event (AE) was reported (no adverse event).
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: A HCP called to report that an expired dose of ROTATEQ (lot: 1908330 expiration: 11/18/2023) to a 2 month old patient on 11/21/2023.  The patient did not experience any adverse issues or side effects due to the administration of the expired vaccine.; A HCP called to report that an expired dose of ROTATEQ (lot: 1908330 expiration: 11/18/2023) to a 2 month old patient on 11/21/2023.  The patient did not experience any adverse issues or side effects due to the administration of the expired vaccine.; This spontaneous report was received from a nurse and refers to a 9-weeks-old patient of unknown gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 21-NOV-2023, when the patient was 2-months-old, they were vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 1 vial (route of administration, and vaccination scheme frequency were not provided; valid lot number 1908330, with an expiration date of 18-NOV-2023) administered for prophylaxis (expired vaccine used). No additional adverse event (AE) or product quality complaint (PQC) were reported.
Age: 8.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No side effects reported.; MMRII was administered today, 1/16/2024, after its labeled expiry date of 1/14/2024; the vaccine has had a previous temperature excursion of 8.6 C for 10 minutes; This spontaneous report was received from a nurse prescriber referring to an 8-year-old patient of unspecified gender. The patient's medical history, concurrent conditions and previous drug reactions or allergies were not reported. Concomitant product included sterile diluent (MERCK STERILE DILUENT) (lot number U036871).   On 16-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) at a dose of 0.5 milliliters (ml) as prophylaxis (dose number, route of administration, and anatomical site of vaccination were not reported). Lot number W001598 has been verified to be valid, expiration date reported and established as 14-JAN-2024 (expired product administered).   It was reported that the vaccine had a previous temperature excursion of 8.6 degrees Celsius for 10 minutes (product storage error). No side effects were reported (no adverse event).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got a horrible case of shingles/suspected vaccination failure; got a horrible case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immune disorder (nos).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got a horrible case of shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got a horrible case of shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JAN-2024 The case was received from the patient via interactive digital media.   The reporter stated her pharmacist was having a client who had immune disease and got the Shingles vaccine shot and then had horrible case of shingles. The reporter also had autoimmune disease rheumatoid arthritis and was told by her pharmacist that she should not get the shingles vaccine shot. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case is linked with US2024AMR007627, same reporter, different patient.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; It was a very small patch of them, maybe a 2 to 3 circle; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: It was a very small patch of them, maybe a 2 to 3 circle). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 16-JAN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she just getting over them, it was a very small patch of them maybe a 2-3 circle, apparently a very mild case and he/she sure it was because he/she had all the vaccinations.  It was also his/her 3rd time having them and he/she did get on medication within the 72-hour window also which he/she sure helped. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Limb discomfort, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: She cannot sleep on it; area was still uncomfortable; her sore arm; sore sholder; This non-serious case was reported by a other health professional and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 4JP7M, expiry date 21-NOV-2025) for prophylaxis.   On 15-DEC-2023, the patient received Shingrix (intramuscular) .5 ml. On 15-DEC-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: her sore arm) and shoulder soreness (Verbatim: sore sholder). On an unknown date, the patient experienced activities of daily living impaired (Verbatim: She cannot sleep on it) and arm discomfort (Verbatim: area was still uncomfortable). The outcome of the pain in arm and shoulder soreness were not resolved and the outcome of the activities of daily living impaired and arm discomfort were not reported.   It was unknown if the reporter considered the pain in arm, shoulder soreness, activities of daily living impaired and arm discomfort to be related to Shingrix.     It was unknown if the company considered the pain in arm, shoulder soreness, activities of daily living impaired and arm discomfort to be related to Shingrix.   Additional Information: RA Receipt date: 11-JAN-2024 The reporter reported that after receiving Shingrix vaccine, patient had sore arm and shoulder which was not recovered till the date of reporting. Patient returned to the pharmacy on 5th January 2025 to report her sore arm. Patient reported that it hurts to put her jacket on, area pinches with range of motion, and shoulder was affected. Patient could not sleep on it, she still had not tired acetaminophen or ibuprofen. On 10th January 2024 patient said that the area was still uncomfortable, and she could not lay on that arm to sleep. Patient still had not tired any medication for the pain. Patient was using a heating pack before bed. Patient did not want reporter to contact her primary care provider. The injection site did not appear swollen or red. The symptoms were not treated. The reporter consented to follow-up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: only diluent was administered; only diluent was administered; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 79-year-old female 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 inappropriate preparation of medication (Verbatim: only diluent was administered) and inappropriate dose of vaccine administered (Verbatim: only diluent was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: RA Receipt Date: 09-JAN-2024 The reporter reported that only diluent was administered which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The healthcare professional did not realized until later. Patient made aware. No adverse events reported by patient.
Sex: U
Vaccine: RSV
Symptoms: Appetite disorder, Swollen tongue
Clinical narrative: tongue swollen; affecting one appetite; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swollen tongue in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced swollen tongue (Verbatim: tongue swollen) and appetite disorder (Verbatim: affecting one appetite). The outcome of the swollen tongue and appetite disorder were not reported.   It was unknown if the reporter considered the swollen tongue and appetite disorder to be related to Arexvy.     It was unknown if the company considered the swollen tongue and appetite disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-JAN-2024 This case was reported by a patient via interactive digital media. The reporter reported that it was horrible noon ever mentioned as one of the symptoms was tongue swollen and affecting one's appetite. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Illness
Clinical narrative: Very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: Very sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 11-JAN-2024 The case was received from the patient via interactive digital media. The patient got the RSV vaccine shot and he/she was very sick. The follow-up would not require per process.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Cant lift my arm to the side without feeling pain, lifting a gallon of milk is painful; Painful and red at the site/Painful arm; Painful and red at the site; Arm stung; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-DEC-2023, the patient received the 1st dose of Shingrix. In DEC-2023, an unknown time after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: Painful and red at the site) and tingling of extremity (Verbatim: Arm stung). On 23-DEC-2023, the patient experienced pain in arm (Verbatim: Painful and red at the site/Painful arm). On an unknown date, the patient experienced activities of daily living impaired (Verbatim: Cant lift my arm to the side without feeling pain, lifting a gallon of milk is painful). The outcome of the pain in arm, erythema of extremities, tingling of extremity and activities of daily living impaired were not resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities, tingling of extremity and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the pain in arm, erythema of extremities, tingling of extremity and activities of daily living impaired to be related to Shingrix.   Additional Information: RA Receipt Date: 08-JAN-2024  The patient reported when she got her first shingles shot first her arm got stung, then as the day and following days continued it was painful and red at the site. The patient went to the doctor the following week the lady who gave a shot advised patient to put heat on the site.  As of today (at the time of reporting) patient could not lift her arm to the side without feeling pain and lifting a gallon of milk was painful. The patient was not sure about getting the second dose of the series. She also stated that she had now spoken with her doctor, and he had prescribed a steroid. The reporter consented to follow up.
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: a dose of Arexvy reconstituted with a diluent other than the one supplied by GSK; a patient had received a dose of Arexvy reconstituted with a diluent other than the one supplied by GSK; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 91-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5FL33) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: a dose of Arexvy reconstituted with a diluent other than the one supplied by RA) and inappropriate dose of vaccine administered (Verbatim: a patient had received a dose of Arexvy reconstituted with a diluent other than the one supplied by RA). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: RA Receipt Date: 10-JAN-2024 The nurse reported that the patient had received a dose of Arexvy reconstituted with a diluent other than the one supplied by GlaxoSmithKline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 0.17
Sex: U
Vaccine: RV1, RV1
Symptoms: Infantile diarrhoea, Regurgitation, Vomiting
Clinical narrative: baby experience prolong diarrhea; Vomiting; she vomit the rotarix; This non-serious case was reported by a physician via call center representative and described the occurrence of diarrhea in a 2-month-old patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and the 1st dose of Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation and not applicable after receiving Rotarix lyophilized formulation, the patient experienced diarrhea (Verbatim: baby experience prolong diarrhea), vomiting (Verbatim: Vomiting) and accidental underdose (Verbatim: she vomit the rotarix). The outcome of the diarrhea, vomiting and accidental underdose were unknown.   It was unknown if the reporter considered the diarrhea to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Unspecified Oral Administration Device. It was unknown if the reporter considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Unspecified Oral Administration Device.     It was unknown if the company considered the diarrhea to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Unspecified Oral Administration Device. It was unknown if the company considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Unspecified Oral Administration Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:12-JAN-2024 The health care professional (HCP) submitted through webform, that they had a patient came in for her vaccines, she vomited the Rotarix, which led to accidental underdose. One of nurse gave another dose and the baby experience prolong diarrhea.  The reporter questioned that, when she should comes in for her 4 months vaccines, do we give them her 2nd dose?  The reporter will be expecting a response back.