chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Confusional state, Device connection issue, Needle issue, Syringe issue, Underdose
Clinical narrative: Patients response: Confusion; the "needle broke off" while they were administering a dose of GARDASIL 9 / 1/2 med went into muscle, 1/2 went out of hub; the "needle broke off" while they were administering a dose of GARDASIL 9; Paatient only received 1/2 dose; This spontaneous report was received from a physician and refers to a patient of a not reported age or gender.  The patient's medical history, concurrent conditions. previous drugs reactions or allergies 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, expiration date 10-OCT-2026 (strength, dose description, lot # and route of administration) as prophylaxis.  On an unknown date, the needle broke off while they were administering a dose of the vaccine, No additional adverse event was reported.  Follow-up information was received from a company representative on 12-DEC-2024.  It was confirmed that the products were not available to be returned to the manufacturer.  Follow-up information was received from a nurse on 16-JAN-2025.  The report concerns to a 17-year-old male patient, his demographics were updated.  On 10-DEC-2024, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via intramuscular in the left deltoid (lot number Y013469 was determined to be a valid number). The prefilled syringe experienced a malfunction, half of the dose went into the muscle, the other half came out of the hub (needle issue and poor quality device used), the patient received only half of dose (accidental underdose). It was reported that patient's response to the incident was confusion. The outcome of the event was not reported.  The causal relationship between the events and the suspect vaccine was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Injection site discomfort
Clinical narrative: Someone received a dose of GARDASIL 9 "on Friday" and now "feels like they have a lump under their arm but when they look there is not a lump" / it felt as if there was a knot there but when I went to feel it there was no knot; This spontaneous report was received from a pharmacist and refers to a female patient of an unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-JAN-2025, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, exact quantity volume, lot #, expiry date, route and anatomical site of administration were not provided) administered for prophylaxis.  On 10-JAN-2025 (also reported as "on Friday and now"), the patient felt like she had a lump under her arm but when she looked there was not a lump, also reported as "it felt as if there was a knot there but when she went to feel it there was no knot" around the injection site (Vaccination site discomfort). At the time of the report the patient had not recovered.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Pain
Clinical narrative: she passed a few months ago; hurting all over; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (she passed a few months ago) and PAIN (hurting all over) in a 9-decade-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (she passed a few months ago) (seriousness criteria death and medically significant) and PAIN (hurting all over) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  The patient was in 80s and received the Moderna COVID shot when came out and was "hurting all over" and stated that the shots were messed whole body up and passed a few months ago. No other details were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-110011 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-110011:Reporter's case; Reported Cause(s) of Death: She passed a few months ago
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antiphospholipid antibodies positive, Atelectasis, Computerised tomogram thorax abnormal, Fibrin D dimer increased, Hepatic steatosis
Clinical narrative: Rt saphenous vein thrombosis with pulmonary embolism.      My Entire Left Deltoid muscle was swollen on 10/12/2023 with rectangular patch at injection site approx 1x3 inches red and itchy. On Oct 15, 2023 a 2 inch diameter round sore swollen area popped up about 2 inches above my right ankle medially, where the saphenous vein is located.  Over the next 2 weeks the area of swelling spread up my leg. No redness was noted. By 10/30/2023  I had severe Rt leg pain, and couldn't bear weight on that leg, so I went to the ER. I was diagnosed with pulmonary embolisms and atelectasis in my right lung, and  a blood clot in the right distal saphenous vein.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Mean platelet volume increased, Muscle swelling
Clinical narrative: Rt saphenous vein thrombosis with pulmonary embolism.      My Entire Left Deltoid muscle was swollen on 10/12/2023 with rectangular patch at injection site approx 1x3 inches red and itchy. On Oct 15, 2023 a 2 inch diameter round sore swollen area popped up about 2 inches above my right ankle medially, where the saphenous vein is located.  Over the next 2 weeks the area of swelling spread up my leg. No redness was noted. By 10/30/2023  I had severe Rt leg pain, and couldn't bear weight on that leg, so I went to the ER. I was diagnosed with pulmonary embolisms and atelectasis in my right lung, and  a blood clot in the right distal saphenous vein.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pulmonary embolism, Scan with contrast abnormal, Superficial vein thrombosis
Clinical narrative: Rt saphenous vein thrombosis with pulmonary embolism.      My Entire Left Deltoid muscle was swollen on 10/12/2023 with rectangular patch at injection site approx 1x3 inches red and itchy. On Oct 15, 2023 a 2 inch diameter round sore swollen area popped up about 2 inches above my right ankle medially, where the saphenous vein is located.  Over the next 2 weeks the area of swelling spread up my leg. No redness was noted. By 10/30/2023  I had severe Rt leg pain, and couldn't bear weight on that leg, so I went to the ER. I was diagnosed with pulmonary embolisms and atelectasis in my right lung, and  a blood clot in the right distal saphenous vein.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tenderness, Ultrasound Doppler abnormal, Weight bearing difficulty
Clinical narrative: Rt saphenous vein thrombosis with pulmonary embolism.      My Entire Left Deltoid muscle was swollen on 10/12/2023 with rectangular patch at injection site approx 1x3 inches red and itchy. On Oct 15, 2023 a 2 inch diameter round sore swollen area popped up about 2 inches above my right ankle medially, where the saphenous vein is located.  Over the next 2 weeks the area of swelling spread up my leg. No redness was noted. By 10/30/2023  I had severe Rt leg pain, and couldn't bear weight on that leg, so I went to the ER. I was diagnosed with pulmonary embolisms and atelectasis in my right lung, and  a blood clot in the right distal saphenous vein.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antiphospholipid antibodies positive, Computerised tomogram thorax abnormal, Injection site reaction, Muscle swelling, Pulmonary embolism
Clinical narrative: Rt saphenous vein thrombosis with pulmonary embolism.      My Entire Left Deltoid muscle was swollen on 10/12/2023 with rectangular patch at injection site approx 1x3 inches red and itchy. On Oct 15, 2023 a 2 inch diameter round sore swollen area popped up about 2 inches above my right ankle medially, where the saphenous vein is located.  Over the next 2 weeks the area of swelling spread up my leg. No redness was noted. By 10/30/2023  I had severe Rt leg pain, and couldn't bear weight on that leg, so I went to the ER. I was diagnosed with pulmonary embolisms and atelectasis in my right lung, and  a blood clot in the right distal saphenous vein.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Respiration abnormal, Ultrasound scan abnormal
Clinical narrative: Rt saphenous vein thrombosis with pulmonary embolism.      My Entire Left Deltoid muscle was swollen on 10/12/2023 with rectangular patch at injection site approx 1x3 inches red and itchy. On Oct 15, 2023 a 2 inch diameter round sore swollen area popped up about 2 inches above my right ankle medially, where the saphenous vein is located.  Over the next 2 weeks the area of swelling spread up my leg. No redness was noted. By 10/30/2023  I had severe Rt leg pain, and couldn't bear weight on that leg, so I went to the ER. I was diagnosed with pulmonary embolisms and atelectasis in my right lung, and  a blood clot in the right distal saphenous vein.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: LEFT UPPER ARM -> RED and  very swollen. Entire upper arm from shoulder to elbow. Red + swollen x 3 days.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Swelling of upper left arm on deltoid region 2 days after the vaccination. Swelling is stable. Warm to the touch, fever to 100.3F, painful to the touch, redness.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDROME; Narrative: Other Relevant HX: Other: GUILLAIN BARRE
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Reported Sysmptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREATHROUGH INFECTOIN; 10084268:COVID-19;  NARRATIVE: Patient was admitted July 21 for COVID 19+ infection. He was discharged to home on July 23. Other Relevant HX: PMH: CAD, HTN, COPD, OSA, and GERD Other:  Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923;VACCINE BREATHROUGH INFECTION; 10084268:COVID-19;  Narrative: Pt was admitted on 7/21 for COVID and discharged to home on 7/25. Other Relevant HX: PMH: HTN, hx of CVA, cognitive disorder, BPH, HLD Other: hospitalization due to COVID-19 infection after having received COVID-19 vaccine
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive, Treatment noncompliance
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19;  Narrative: Patient was admitted for COVID-19 infection 7/19 and left AMA on 7/26  Other Relevant HX: PMH: HTN, COPD, bipolar disorder, substance abuse, OSA  Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: admitted on 7/19 and discharged to home on 7/21. Other Relevant HX: PMH: myasthenia gravis, Parkinson's, dementia, HTN, HLD, tobacco use Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: admitted 7/22 and discharged from hospital to home on 7/25  Other Relevant HX: PMH: Atrial fibrillation, HTN, T2DM, BPH, and OSA  Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, COVID-19 pneumonia, Mental status changes, Pneumonia, Pneumonia bacterial
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient was hospitalized for community acquired pneumonia and COVID-19 PNA (deemed asymptomatic). Patient received Augmentin and azithromycin for treatment of bacterial pneumonia. He did not receive treatment for COVID, but was found to be positive on admission. He initially presented with altered mental status. Other Relevant HX:  Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient was hospitalized for community acquired pneumonia and COVID-19 PNA (deemed asymptomatic). Patient received Augmentin and azithromycin for treatment of bacterial pneumonia. He did not receive treatment for COVID, but was found to be positive on admission. He initially presented with altered mental status. Other Relevant HX:  Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure diastolic decreased, Bradycardia, Breakthrough COVID-19, Computerised tomogram thorax normal, Dizziness
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREATHROUGH INFECTION; 10084268: COVID-19;  Narrative: HOSPITAL COURSE: Patient was admitted to the hospital for further work-up of bradycardia, dizziness, and hypoxia. He was placed on supplemental O2 2L/min initially. Of note, patient was found to have COVID 19 for which he had just finished a Paxlovid course (started 6/25/24). From the COVID perspective patient was doing well and is inflammatory markers were unremarkable. Patient was saturating greater than 92% on room air. Patient also had orthostatics done for which he was positive where he dropped 10 mmHg and diastolic. Because of this IV fluids were given to the patient and responded appropriately. Of note, patient was also found to have bouts of bradycardia for which patient was asymptomatic at the time. on 7/4, patient was hemodynamically stable and symptomatic bradycardia.  Other Relevant HX: Patient was prescribed Paxlovid in outpatient setting prior to hospitalization. Patient presented to the hospital for asymptomatic bradycardia and hypoxemia that may have been related to the COVID-19 infection since patient was still testing positive in the hospital. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Inflammatory marker test, SARS-CoV-2 test positive, Scan with contrast normal
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREATHROUGH INFECTION; 10084268: COVID-19;  Narrative: HOSPITAL COURSE: Patient was admitted to the hospital for further work-up of bradycardia, dizziness, and hypoxia. He was placed on supplemental O2 2L/min initially. Of note, patient was found to have COVID 19 for which he had just finished a Paxlovid course (started 6/25/24). From the COVID perspective patient was doing well and is inflammatory markers were unremarkable. Patient was saturating greater than 92% on room air. Patient also had orthostatics done for which he was positive where he dropped 10 mmHg and diastolic. Because of this IV fluids were given to the patient and responded appropriately. Of note, patient was also found to have bouts of bradycardia for which patient was asymptomatic at the time. on 7/4, patient was hemodynamically stable and symptomatic bradycardia.  Other Relevant HX: Patient was prescribed Paxlovid in outpatient setting prior to hospitalization. Patient presented to the hospital for asymptomatic bradycardia and hypoxemia that may have been related to the COVID-19 infection since patient was still testing positive in the hospital. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Atherectomy, Breakthrough COVID-19, Catheterisation cardiac abnormal, Chest X-ray normal, Chest discomfort
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Pt presents with 4 days of atypical chest pain found to have elevated troponin in the ED. Pt was admitted to medicine for further ACS workup. Cardiology was consulted and heparin drip was initiated on admission along with aspirin and high intensity statin. Initially discussed possibility of type II MI vs COVID myocarditis. Serial troponins continued to rise. Pt underwent LHC with pRCA stenting. No medications were started for treatment for COVID-19. Chest pain resolved during hospitalization & patient was discharged home after 1 day. Other Relevant HX: Patient with PMH of HTN, T2DM complicated by peripheral neuropathy, HLD who presents with 4 days of central chest pain/pressure. Hx of smoking. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Coronary arterial stent insertion, Coronary artery occlusion, Echocardiogram abnormal, Ejection fraction abnormal
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Pt presents with 4 days of atypical chest pain found to have elevated troponin in the ED. Pt was admitted to medicine for further ACS workup. Cardiology was consulted and heparin drip was initiated on admission along with aspirin and high intensity statin. Initially discussed possibility of type II MI vs COVID myocarditis. Serial troponins continued to rise. Pt underwent LHC with pRCA stenting. No medications were started for treatment for COVID-19. Chest pain resolved during hospitalization & patient was discharged home after 1 day. Other Relevant HX: Patient with PMH of HTN, T2DM complicated by peripheral neuropathy, HLD who presents with 4 days of central chest pain/pressure. Hx of smoking. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Troponin increased
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Pt presents with 4 days of atypical chest pain found to have elevated troponin in the ED. Pt was admitted to medicine for further ACS workup. Cardiology was consulted and heparin drip was initiated on admission along with aspirin and high intensity statin. Initially discussed possibility of type II MI vs COVID myocarditis. Serial troponins continued to rise. Pt underwent LHC with pRCA stenting. No medications were started for treatment for COVID-19. Chest pain resolved during hospitalization & patient was discharged home after 1 day. Other Relevant HX: Patient with PMH of HTN, T2DM complicated by peripheral neuropathy, HLD who presents with 4 days of central chest pain/pressure. Hx of smoking. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Ageusia, Asthenia, Breakthrough COVID-19, Cholecystitis
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Pt was admitted to the hospital due to severe abdominal pain. Was found to have gastritis/duodenitis/cholecystitis as primary diagnosis. Several days into the hospitalization, pt reported cough, congestion, sore throat, runny nose, generalized weakness, and loss of taste. Tested positive for COVID 19 infection - no hypoxemia. Discussed option for tx w/ remdesivir given age >65. Discussed risks/benefits and patient opted for treatment. Experienced symptom improvement and was discharged home. Other Relevant HX: PMH of diverticulitis, hyperlipidemia, DM, and hypertension, presented with diffuse abdominal pain. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Duodenitis, Gastritis, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Pt was admitted to the hospital due to severe abdominal pain. Was found to have gastritis/duodenitis/cholecystitis as primary diagnosis. Several days into the hospitalization, pt reported cough, congestion, sore throat, runny nose, generalized weakness, and loss of taste. Tested positive for COVID 19 infection - no hypoxemia. Discussed option for tx w/ remdesivir given age >65. Discussed risks/benefits and patient opted for treatment. Experienced symptom improvement and was discharged home. Other Relevant HX: PMH of diverticulitis, hyperlipidemia, DM, and hypertension, presented with diffuse abdominal pain. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Pt was admitted to the hospital due to severe abdominal pain. Was found to have gastritis/duodenitis/cholecystitis as primary diagnosis. Several days into the hospitalization, pt reported cough, congestion, sore throat, runny nose, generalized weakness, and loss of taste. Tested positive for COVID 19 infection - no hypoxemia. Discussed option for tx w/ remdesivir given age >65. Discussed risks/benefits and patient opted for treatment. Experienced symptom improvement and was discharged home. Other Relevant HX: PMH of diverticulitis, hyperlipidemia, DM, and hypertension, presented with diffuse abdominal pain. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Blood lactic acid increased, Breakthrough COVID-19, Chest X-ray normal, Chronic obstructive pulmonary disease
Clinical narrative: Reported Symptoms: 10054112:HOSPITALSATION; 100676923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient reports that few days ago he had worsening shortness of breath and was prescribed 3 day course of prednisone which he completed yesterday evening. He still had increased shortness of breath with a clear productive cough this morning and presented to the ED with shortness of breath and inability to speak due to shortness of breath. In the ED they did back-to-back treatments of duo nebs, IV solumedrol, IV magnesium and 2L fluids along with IV ceftriaxone. Was admitted for COPD exacerbation secondary to COVID-19. Dexamethasone and remdesivir were started upon admission. Patient experienced symptomatic improvement and was discharged home. Other Relevant HX: PMHx of COPD GOLD D not on home O2, HTN, HLD, PAD, gout, melanoma s/p resection and colonic pseudo-obstruction presenting to the ED for shortness of breath. Admitted for COPD exacerbation secondary to COVID-19 infection. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Full blood count, Gram stain positive, Productive cough
Clinical narrative: Reported Symptoms: 10054112:HOSPITALSATION; 100676923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient reports that few days ago he had worsening shortness of breath and was prescribed 3 day course of prednisone which he completed yesterday evening. He still had increased shortness of breath with a clear productive cough this morning and presented to the ED with shortness of breath and inability to speak due to shortness of breath. In the ED they did back-to-back treatments of duo nebs, IV solumedrol, IV magnesium and 2L fluids along with IV ceftriaxone. Was admitted for COPD exacerbation secondary to COVID-19. Dexamethasone and remdesivir were started upon admission. Patient experienced symptomatic improvement and was discharged home. Other Relevant HX: PMHx of COPD GOLD D not on home O2, HTN, HLD, PAD, gout, melanoma s/p resection and colonic pseudo-obstruction presenting to the ED for shortness of breath. Admitted for COPD exacerbation secondary to COVID-19 infection. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Troponin normal, White blood cell count increased
Clinical narrative: Reported Symptoms: 10054112:HOSPITALSATION; 100676923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient reports that few days ago he had worsening shortness of breath and was prescribed 3 day course of prednisone which he completed yesterday evening. He still had increased shortness of breath with a clear productive cough this morning and presented to the ED with shortness of breath and inability to speak due to shortness of breath. In the ED they did back-to-back treatments of duo nebs, IV solumedrol, IV magnesium and 2L fluids along with IV ceftriaxone. Was admitted for COPD exacerbation secondary to COVID-19. Dexamethasone and remdesivir were started upon admission. Patient experienced symptomatic improvement and was discharged home. Other Relevant HX: PMHx of COPD GOLD D not on home O2, HTN, HLD, PAD, gout, melanoma s/p resection and colonic pseudo-obstruction presenting to the ED for shortness of breath. Admitted for COPD exacerbation secondary to COVID-19 infection. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Renal failure
Clinical narrative: Online report of death by renal failure approximately 4 months after 2nd inoculation of EUA medical countermeasure deemed "COVID-19 vaccine". Manufacturer, dose dates and lot numbers are unknown. Regardless of manufacturer, either Moderna or Pfizer-Biotech, this adverse event does not appear to have been enumerated into VAERS. As a result, the fatal post inoculation adverse event of this patient will receive the required enumeration as per the EUA.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden unexpected at death of EUA medical countermeasure recipient. Online report indicates he passed away peacefully on 01/02/2025. Unable to ascertain DOB. DOB is just an estimate. A review of his social media post indicate his second injection was on 05/04/21 and prior post has a picture with his son holding a pharmacy sign. Therefore, its likely he was injected at a pharmacy location. Information on manufacturer, LOT #, DOSE#1 date unavailable. Victim made a post about the presence of black mold on the walls of his apartment within a year of death.
Age: 17.0
Sex: M
Vaccine: COVID19, FLU3, HEP, HEPA, HPV9, IPV, MENB, MMR, MNQ, TDAP, VARCEL
Symptoms: Eye oedema, Face oedema, Oedema peripheral, Pruritus, Rash
Clinical narrative: Approximately 30-45 minutes post vaccine administration child began to complain of itching/rash to neck assessed by Medical Coordinator. rash/wells noted bilat arms neck front and back torso Benadryl 50mg administered p.o., dispensed hydrocortizone cream for child to apply. given ice pack for comfort Edema to face hands eyes noted within 10 minutes post initial assessment PCP made aware. administer epi-pen. child taken to hospital ED. child treated in ER with Benadryl IV. IVFluids, prednisone. 1/23/25 @ 7:15am. child denies itching. rash/edema resolving Child will be assessed by PCP this afternoon
Age: 1.0
Sex: M
Vaccine: MENHIB, MMR
Symptoms: Erythema, Lip discolouration, Staring, Unresponsive to stimuli
Clinical narrative: Unresponsive to stimuli; Erythema; Staring; Cyanosis; Information was obtained on a request by The Company from the Agency (agency # AU-TGA-0000827465) via a Public Case Detail, received by a physician concerning a 1-year-old male patient. The patient's medical history included fever and coryzal symptoms. His concurrent conditions and concomitant therapies were not reported. Previous vaccine reaction reported as not applicable.  On 07-JUN-2015, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, dose, lot #, expiry date, route of administration, and indication were not provided); and hib vaccine conj (tet tox), meningococcal vaccine c conj (tet tox) (MENITORIX) (strength, formulation, dose, lot #, expiry date, route of administration, and indication were not provided).  On 14-JUN-2015, the patient experienced cyanosis. On the same day at 17:30, the patient experienced erythema, staring, unresponsive to stimuli (reported as 3-minute episode blank stare, nil response, red face, purple lips). No seizing of limbs/torso. In addition, per ''ED'' review no neurological signs of upper respiratory tract infection (URTI). On 14-JUN-2015, the patient recovered from the event of cyanosis. On the same day at 17:33, the patient recovered from the events of erythema, staring, and unresponsive to stimuli. General pediatric review follow up.  The reporter considered all the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and hib vaccine conj (tet tox), meningococcal vaccine c conj (tet tox) (MENITORIX).  Upon internal review the event of unresponsive to stimuli was considered as medically significant.
Sex: F
Vaccine: 6VAX-F, PNC, RV5
Symptoms: Seizure
Clinical narrative: Seizure; Information has been received from health authority (#AU-TGA-0000827457). This spontanous report was received from physician and refers to female patient in the age less than 1 year.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 15-MAR-2011, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); pneumococcal vaccine conj 7v (crm197) (PREVENAR), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); and  diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX HEXA), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).  On 15-MAR-2011, the patient experienced seizure. On an unknown date, the patient was admitted to the hospital due to seizure. On 16-MAR-2011, the patient recovered from the event of seizure.   The reporter considered seizure to be related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The reporter considered seizure to be medically significant.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Morbillivirus test positive, Pyrexia, Rash
Clinical narrative: Mom brought patient into the office on 1/17/2025 for a rash that showed up on his abdomen, upper thighs, and diaper area. Per mom, patient had also had a fever x 2 days before rash appeared.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Facial spasm, Magnetic resonance imaging head abnormal, Muscle spasms, Neurovascular conflict
Clinical narrative: Three hours later began three days of severe muscle spasms in neck, head, body. Lost bladder control, had pains running down my legs. Voice began to hurt, when talking would vibrate in my head. Spasms did not stop for all three,days. months later pains in legs cleared and bladder control restored. I could not get to Drs had just moved here so no primary. Later was given gabapentin and carbamazapine. Saw neurologist who said he would not and could not help me until CDC report issued.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Paraesthesia, Urinary incontinence
Clinical narrative: Three hours later began three days of severe muscle spasms in neck, head, body. Lost bladder control, had pains running down my legs. Voice began to hurt, when talking would vibrate in my head. Spasms did not stop for all three,days. months later pains in legs cleared and bladder control restored. I could not get to Drs had just moved here so no primary. Later was given gabapentin and carbamazapine. Saw neurologist who said he would not and could not help me until CDC report issued.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia
Clinical narrative: patient's mother, called this nurse and reported that patient still has some left shoulder pain, mainly located in the joint.  this has continued since getting her vaccine on 12-31-24.  She does play sports and thought maybe it was related to that but shes not sure.  She has not been back to the pcp yet.  has tried advil for the pain.  I advised the vaccine could have been given a bit high on the deltoid, and it should be ok but recommended she contact her doctor for advice and that I would do this report.  mom is agreeable to this.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Given flu shot twice in one season. Client received flu vaccine in 9/24 and received same vaccine 1/21/25
Age: 15.0
Sex: F
Vaccine: MMR, MNQ, TDAP, VARCEL
Symptoms: Fatigue, Headache, Syncope
Clinical narrative: SYNCOPE EVENT OCCURED AFTER VACCINE ADMINISTRATION THAT LASTED APPROX 20 SECONDS,PT WAS PLACED IN THE RECUMBANT POSITION AS SYNCOPE WAS OCCURRING. PT CO HEADACHE AND FEELING TIRED VITAL SIGNS MONITORED, PT DRANK H20,ASSISTED TO CHAIR,STATED SHE FELT BETTER AND ASKED TO GO HOME. PT REFUSED OFFER TO BE EVALUATED AT THE ER. SHE WAS ADVISED TO SEEK MEDICAL ATTENTION FOR ANY FURTHER CONCERNS,EPISODES. PT LEFT CLINIC AT9;50 AM, ACCOMPANIED BY HER MOTHER AND COUSIN
Age: 25.0
Sex: F
Vaccine: CHIK
Symptoms: Blood glucose decreased, Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: The patient came to the pharmacy after receiving four other vaccinations from the travel clinic. She then received the Chikengunya vaccine and stated she felt fine. We walked from the vaccination room back to the pharmacy where she stood for a few minutes before proceeding to the counter to receive other travel medications. When she was checking out, she stated that she felt faint and the pharmacist came around the counter to help in case she passed out, which she did. She fell faster than the pharmacist could react and the patient hit her head on the counter with no obvious signs of trauma from the impact. We placed her on the floor until she regained consciousness. She sat in a chair for about 30 minutes and a rapid response was called. She was checked out by a couple of nurses, cleared, and left the pharmacy that day.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Hot flush, Migraine
Clinical narrative: Extreme fatigue, extreme dizziness, horrible body aches, feeling lightheaded, migraine since last night it?s 11:18am. No appetite, nausea/ vomiting, hot flashes.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Extreme fatigue, extreme dizziness, horrible body aches, feeling lightheaded, migraine since last night it?s 11:18am. No appetite, nausea/ vomiting, hot flashes.
Age: 84.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Product administered at inappropriate site
Clinical narrative: Routine getting two shots in same arm
Age: 68.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Diarrhoea, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Nausea, diarrhea, chills, sweating, muscle aches,, headache
Age: 68.0
Sex: M
Vaccine: TYP
Symptoms: Nausea
Clinical narrative: Nausea, diarrhea, chills, sweating, muscle aches,, headache
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: nothing
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Mom reported in January 2025 that patient's left arm cannot be raised above his head for more than 30 seconds without his arm/hand going number. It started on the day he got the vaccine and did not occur prior to vaccine. Does not occur in his other arm.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse reaction occurred , RN administered two flu vaccines.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness developed down the arm away from the injection site toward the elbow later that day after the injection.  Upon questioning patient stated this had happened before in the past when she had received a pneumonia vaccine. At that time she did not receive treatment and the redness went away. I encouraged patient to reach out to primary caregiver to be evaluated.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site induration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient report on 1-19-2025 rash, pain and swelling at the injection site. Patient was ordered Benadryl and Zyrtec once on that day.   The was reported to NP on 1/22/2025.  The Vaccine nurse access the site on 1/23/2025 @ 0800.   Patient had sight hardness at the injection site decrease swelling and slight scan of rash present. Patient report feeling better.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received an accidental third dose of Proquad: human error. No reactions noted at this time.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Patient vomiting about 5 hours after the immunization that has continued into the morning of 1/23/25. Seen in office for this with no other symptoms outside of vomiting.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient reports itching (full body) beginning two days after immunization. Pharmacist looked at patient hx and she has received the same vaccine before (same manufacturer). Patient reported no other environmental or medication changes.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: On 11/05/2024 at 5:30pm one of the medical assistants gave patient the covid vaccine Pfizer-BioNTech COVID-19 Vaccine unfraternally was the wrong vaccines for patient's age. Patient's mother was notified, and patient follow up with provider on 11/12/2024.  Per Visit note no reaction, patient was feeling well and was advised to follow up if any further concerns.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: No immediate or later reported adverse events thus far although wrong vaccination was administered - patient was supposed to receive second dose of Bexsero vaccine but instead received a third dose of Menquadfi vaccine.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Deafness unilateral, Magnetic resonance imaging ear, Magnetic resonance imaging normal
Clinical narrative: COMPLETE HEARING LOSS IN ONE EAR ONE WEEK AFTER RECEIVING VACCINE. VISITED AUDIOLOGIST, FAMILY DOCTOR AND THEN ENT SPECIALIST TWICE. HE WAS STARTED ON 2 ROUNDS OF PREDISONE, HEARING WAS COMPLETELY GONE FOR 2 WEEKS AND WOULD COME AND GO FOR THE UPCOMING WEEKS. IT HAS IMPROVED IN THE LAST WEEK, ABOUT A MONTH AFTER THE VACCINE. NO OTHER SYMPTOMS OTHER THAN SUDDEN HEARING LOSS
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden hearing loss
Clinical narrative: COMPLETE HEARING LOSS IN ONE EAR ONE WEEK AFTER RECEIVING VACCINE. VISITED AUDIOLOGIST, FAMILY DOCTOR AND THEN ENT SPECIALIST TWICE. HE WAS STARTED ON 2 ROUNDS OF PREDISONE, HEARING WAS COMPLETELY GONE FOR 2 WEEKS AND WOULD COME AND GO FOR THE UPCOMING WEEKS. IT HAS IMPROVED IN THE LAST WEEK, ABOUT A MONTH AFTER THE VACCINE. NO OTHER SYMPTOMS OTHER THAN SUDDEN HEARING LOSS
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Crying
Clinical narrative: Inconsolability with spontaneous resolution, thought to have been an intusussception.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure increased, Chills, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Chills, Fever 101, elevated blood pressure (180/110 mmHg, normally 160/80 mmHg), pulse 115, swollen arm at injection-site with warmth over injection site. Patient took Tylenol and clonidine to resolve. Symptoms lasted 24 hours
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Vertigo
Clinical narrative: DEVELOPED VERTIGO ONE DAY AFTER INJECTION LASTED FOR 4 DAYS.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: NONE
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Decreased appetite, Erythema, Influenza like illness, Skin swelling
Clinical narrative: Flu-like symptoms, loss of appetite, skin red and swollen. No fever. Symptoms lasted for 4 to 5 days
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Back pain, Exposure during pregnancy, Headache, Immediate post-injection reaction
Clinical narrative: Pregnancy due date 06/27/25. Unsure of which flu test. Immediate pain in stomach. Vomiting 1 hr after receiving dose. Extreme muscle weakness and head pain 2 hrs after dose, feeling like head is spinning. Unable to move on own without the help of fiancé. Extreme pain in head, legs, and back roughly 4 hrs and still experiencing this 28 hrs later. Going to hospital
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity, Vertigo, Vomiting
Clinical narrative: Pregnancy due date 06/27/25. Unsure of which flu test. Immediate pain in stomach. Vomiting 1 hr after receiving dose. Extreme muscle weakness and head pain 2 hrs after dose, feeling like head is spinning. Unable to move on own without the help of fiancé. Extreme pain in head, legs, and back roughly 4 hrs and still experiencing this 28 hrs later. Going to hospital
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test, Catheterisation cardiac, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: I was hospitalized at the ER with breathing problems I had never had before within weeks of my vaccination and later diagnosed with pulmonary hypertension
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary hypertension
Clinical narrative: I was hospitalized at the ER with breathing problems I had never had before within weeks of my vaccination and later diagnosed with pulmonary hypertension
Age: 63.0
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received rsv shots a year apart. Pt does not have any symptoms. After speaking with the pt she is doing well and has no concerns
Age: 9.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood creatine phosphokinase, C-reactive protein, Differential white blood cell count, Full blood count, Liver function test
Clinical narrative: Child developed rhabdomyolysis following vaccinations. She required hospitalization overnight. Her calves were the main area causing pain. She was also running a fever around 100-102 for 4 days. She recovered after administering aggressive hydration.
Age: 9.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Metabolic function test, Myoglobin blood, Pain in extremity, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Child developed rhabdomyolysis following vaccinations. She required hospitalization overnight. Her calves were the main area causing pain. She was also running a fever around 100-102 for 4 days. She recovered after administering aggressive hydration.
Age: 9.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rhabdomyolysis, Urine analysis
Clinical narrative: Child developed rhabdomyolysis following vaccinations. She required hospitalization overnight. Her calves were the main area causing pain. She was also running a fever around 100-102 for 4 days. She recovered after administering aggressive hydration.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Rash pruritic, Urticaria
Clinical narrative: hives 1 day after vaccine administration that subsided but patient is still has a slight pruritic rash
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: I received the Pfizer vaccine during pregnancy and am concerned about its potential impact on babies.  I had the vaccine during my third trimester, and my daughter has experienced afebrile seizures (which are not typical in either my or my husband?s family) and delays in speech development. SHE IS BORN
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient and her wife came in together and asked for an RSV vaccine because their adult daughter has been severely ill with RSV for a month. They are under 75 years old, so I informed them that it was no longer indicated unless they had increased risk. They both said they were diabetic and in their late 60's so wanted to go ahead and get vaccinated. I asked if they had every gotten an RSV shot, both indicated that they had not, and our pharmacy software also did not show they had gotten it as far back as the profile shows. We administered the vaccine to each of them. The next day we were notified by our corporate that they both had already received this vaccine 10/5/23. I informed the patients. They did not realize they had ever received it. They were not upset, and they were not experiencing any adverse reaction. They are doing well but know to follow up if anything changes.
Age: 11.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient given 2nd dose Hep A on 1/22/2025 - first dose was 10/16/2024 - Given too early based on immunization schedule.  Patient given MMRV on 1/22/2025 -  last two doses given 6/13/2015 and 10/16/2024 - MMR was not needed, patient should have only received Varicella
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Limb discomfort, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient is trying to get appointment with neurologist for next week.  She states the next day after the shot her muscles in right arm felt heavy when trying to lift.  Some tingling in the fingers when holding things and pain from pinky finger all the way up the arm.  The symptoms are worse when lifting something and then dull throughout the day with little pain but it is annoying.  States it also feels like she has a knot in her arm but it is on the underside/backside of arm, not where the shot was given.  It also feels like she has a knot in the back of her shoulder.  States she also had ghost pain in the same spot in her other arm that lasted for a few days but then went away.  Patient stated she had a similar issue years ago so she is not sure if this is from the shot or not or if the shot irritated the nerve pain.  She had to do physical therapy years ago due to nerve pain/damage in her arm from leaning on it and long commutes.  Patient also stated she has chronic nerve pain she is being treated for.  After the shot she went shopping and used her right arm where the shot was given to lift a bag of oranges and that may have been the start of it.  Patient also had fatigue for about 5 days after that vaccine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Periarthritis
Clinical narrative: Adhesive capsulitis