chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Malaise, Pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: On December 3, 2022, I was extremely tired. The next day I woke with body aches and a bad headache. In general, I just felt ill. I took a home test and was positive COVID-19. On Monday and Tuesday, I still felt very ill and started to have a runny nose and a cough and diarrhea. On Wednesday I began to feel better. The rest of the week I didn't feel worse, but I didn't feel much better. On the 11th and 12th, I felt better. Yesterday I felt terrible again because I didn't have any energy, but I feel better today. I was prescribed PAXLOVID but I did not take it.
Age: 58.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Herpes zoster
Clinical narrative: Developed Herpes Zoster outbreak one week on my left side of body after receiving vaccine. I?ve never had this before.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was given Pfizer 6month - 4year monovalent as a booster  instead of Pfizer 5-11 year Pfizer bivalent
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered Pfizer vaccine LOT FX5095 EXP 01/31/2023 for third dose in primary series as medication error for patient. As of 12/08/2022, Pfizer 6MO-4YO monovalent vaccine was not authorized to administer for third dose in primary series. Patient was administered Pfizer dose at approximately 3:45PM in office by registered nurse. Patient was monitored for fifteen minutes. Left office with mother feeling well, alert and oriented, and in good spirits.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Cough, Dry throat, Headache, Pain
Clinical narrative: at night body ache, headache and low grade fever 100.2 the next morning still body ache and very dry iitchy throat and dry cough having chills.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test, Throat irritation
Clinical narrative: at night body ache, headache and low grade fever 100.2 the next morning still body ache and very dry iitchy throat and dry cough having chills.
Age: 94.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Condition aggravated, Fungal skin infection, Rash, Rash erythematous, Rash morbilliform
Clinical narrative: Full body rash from neck down. Legs had ?measles like appearance? and arms and hands were very red. Very itchy.  Already had a groin rash from yeast, being treated but that got worse.  Caused 2 trips to ER and dermatologist visit.  Treated with  topical and oral steroids, antihistamines. Much improved but still some rash remaining.
Age: 94.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Rash pruritic
Clinical narrative: Full body rash from neck down. Legs had ?measles like appearance? and arms and hands were very red. Very itchy.  Already had a groin rash from yeast, being treated but that got worse.  Caused 2 trips to ER and dermatologist visit.  Treated with  topical and oral steroids, antihistamines. Much improved but still some rash remaining.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix(age 4-6years) was given to 7 yr old. Pediatrician called parent- no side effects.
Age: 67.0
Sex: M
Vaccine: COVID19-2, PNC20
Symptoms: Skin warm, Swelling, Tenderness, Urticaria
Clinical narrative: Patient received Prevnar 20 vaccination in left deltoid. Reported to pharmacy staff on 12/14/22 that on 12/13/22 he began experience a "red welt" on skin under arm near the axillary area that was tender, swollen and warm to the touch. Patients states that he has not taken anything or sought medical care for the adverse event,  and that is has been stable over the last 24 hours.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was accidentally given a high dose flu shot instead of the normal under 65 year old dose.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Ultrasound lymph nodes
Clinical narrative: I experienced lymph node pain with all vaccinations, first, second and third within 12 hours.  I had considerable swelling and pain with left armpit lymph node after the second for a week before it began to get better, the third vaccination was not as bad with the pain and swelling.  In August 2022, after the third vaccination in December 2021, my left armpit lymph node increased in pain from annoying to very painful.  Had ultrasound done in October 2022, nothing abnormal found.  told me to alternate hot/cold.  Pain remains but not nearly as bad and only occasional now.  Overall, all three Covid vaccines made me very sick.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flu vaccine was given for 4 month old baby. Pediatrician spoke with mother after the visit. No side effects reported. All concerned and questions were answered by the doctor.
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient incorrectly given Bivalent Booster dose and starting dose, has not completed initial mRNA series
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: RASH AND SWELLING
Age: 32.0
Sex: U
Vaccine: COVID19-2
Symptoms: Genital odour, Pruritus genital
Clinical narrative: Itchy and smelly balls
Age: 40.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Rash pruritic
Clinical narrative: itch and rash
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was administered Pfizer Bivalent 5-11 instead of Monovalent  vaccine as a first dose.
Age: 73.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Psoriasis, Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Began having a blotchy, red rash on my upper back between my left shoulder blade and my shoulder joint. Began early November. About 3 or 4 patches 1 inch in diameter each. It itches. Pointed it out to my dermatologist during my normal 6-month checkup Nov 30.  I have had all 3 types of skin cancer in the past and see him every 6 months for an evaluation. I asked if it could be Eczema. His response was it looked more like Psoriasis, and he asked if I ever had that. I said no. He prescribed Betamethasone Dipropionate cream to use twice a day to see if it would clear. It has started clearing.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Very tired, uncontrollable shivering,  fever (up to 101.4 degrees), mild headache, stomach pain, treated with ibuprofen 200 mg every 4 - 6 hours. Symptoms mostly gone 30 hours after injection.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Blood test abnormal, Computerised tomogram head, Disability, Facial pain
Clinical narrative: After the first shot, I had what felt like a possible oncoming sinus infection. It felt as though it resolved before the second he room. After the second injection, I began having unexplained neuropathy, a typical facial pain, extreme sinus pressure (no mucus or post nasal drip never presented) and pain without reprieve or medications, myalgia and musculoskeletal pain and disabilities within my joints. Rapid heart rate upon standing or bending to the floor. Weight loss, daily, consistent migraines and headaches, sudden daytime sleepiness. Frequent urination (average 10x an hour if I don?t use electrolytes everyday. Bloodwork shows only that there is inflammation in the body. I have no autoimmune disorder or dysfunction. I had zero prior health problems and was very active and ate healthy foods.  I had to take a leave of absence from work. My condition has disabled me and since I had never contracted Covid-19, i wear N-95s in indoor spaces, and test regularly. I was heavily testing for Covid 19 from February 2021 through April 2021, as I was returning to work for the year.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Heart rate increased, Impaired work ability, Inflammation, Magnetic resonance imaging head
Clinical narrative: After the first shot, I had what felt like a possible oncoming sinus infection. It felt as though it resolved before the second he room. After the second injection, I began having unexplained neuropathy, a typical facial pain, extreme sinus pressure (no mucus or post nasal drip never presented) and pain without reprieve or medications, myalgia and musculoskeletal pain and disabilities within my joints. Rapid heart rate upon standing or bending to the floor. Weight loss, daily, consistent migraines and headaches, sudden daytime sleepiness. Frequent urination (average 10x an hour if I don?t use electrolytes everyday. Bloodwork shows only that there is inflammation in the body. I have no autoimmune disorder or dysfunction. I had zero prior health problems and was very active and ate healthy foods.  I had to take a leave of absence from work. My condition has disabled me and since I had never contracted Covid-19, i wear N-95s in indoor spaces, and test regularly. I was heavily testing for Covid 19 from February 2021 through April 2021, as I was returning to work for the year.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Musculoskeletal pain, Myalgia, Neuropathy peripheral, New daily persistent headache
Clinical narrative: After the first shot, I had what felt like a possible oncoming sinus infection. It felt as though it resolved before the second he room. After the second injection, I began having unexplained neuropathy, a typical facial pain, extreme sinus pressure (no mucus or post nasal drip never presented) and pain without reprieve or medications, myalgia and musculoskeletal pain and disabilities within my joints. Rapid heart rate upon standing or bending to the floor. Weight loss, daily, consistent migraines and headaches, sudden daytime sleepiness. Frequent urination (average 10x an hour if I don?t use electrolytes everyday. Bloodwork shows only that there is inflammation in the body. I have no autoimmune disorder or dysfunction. I had zero prior health problems and was very active and ate healthy foods.  I had to take a leave of absence from work. My condition has disabled me and since I had never contracted Covid-19, i wear N-95s in indoor spaces, and test regularly. I was heavily testing for Covid 19 from February 2021 through April 2021, as I was returning to work for the year.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Pollakiuria, SARS-CoV-2 test negative, Sinus pain, Somnolence
Clinical narrative: After the first shot, I had what felt like a possible oncoming sinus infection. It felt as though it resolved before the second he room. After the second injection, I began having unexplained neuropathy, a typical facial pain, extreme sinus pressure (no mucus or post nasal drip never presented) and pain without reprieve or medications, myalgia and musculoskeletal pain and disabilities within my joints. Rapid heart rate upon standing or bending to the floor. Weight loss, daily, consistent migraines and headaches, sudden daytime sleepiness. Frequent urination (average 10x an hour if I don?t use electrolytes everyday. Bloodwork shows only that there is inflammation in the body. I have no autoimmune disorder or dysfunction. I had zero prior health problems and was very active and ate healthy foods.  I had to take a leave of absence from work. My condition has disabled me and since I had never contracted Covid-19, i wear N-95s in indoor spaces, and test regularly. I was heavily testing for Covid 19 from February 2021 through April 2021, as I was returning to work for the year.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased, X-ray
Clinical narrative: After the first shot, I had what felt like a possible oncoming sinus infection. It felt as though it resolved before the second he room. After the second injection, I began having unexplained neuropathy, a typical facial pain, extreme sinus pressure (no mucus or post nasal drip never presented) and pain without reprieve or medications, myalgia and musculoskeletal pain and disabilities within my joints. Rapid heart rate upon standing or bending to the floor. Weight loss, daily, consistent migraines and headaches, sudden daytime sleepiness. Frequent urination (average 10x an hour if I don?t use electrolytes everyday. Bloodwork shows only that there is inflammation in the body. I have no autoimmune disorder or dysfunction. I had zero prior health problems and was very active and ate healthy foods.  I had to take a leave of absence from work. My condition has disabled me and since I had never contracted Covid-19, i wear N-95s in indoor spaces, and test regularly. I was heavily testing for Covid 19 from February 2021 through April 2021, as I was returning to work for the year.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Colon cancer
Clinical narrative: In June diagnosed with colon cancer
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Metastases to liver, Renal cell carcinoma
Clinical narrative: Patient already went through colon cancer treatment; now with new renal cell cancer in April needing surgery; then in August '22 has liver metastases
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Bladder dysfunction, Computerised tomogram head abnormal, Diplegia, Functional gastrointestinal disorder, Magnetic resonance imaging abdominal
Clinical narrative: Completely healthy athletic 16 y/o given menactra and 1 days later started with rapid onset LE paralysis with rapid progression to upper extremities, resulting in loss of function of bowel and bladder. Worked up and MRI confirmed transverse myelitis. Transported to highly specialized neurology at hospital. Initial Admission 9/13/22 and then transfer to hospital for 34 days: 9/14-10/19/2022.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Magnetic resonance imaging spinal abnormal, Myelitis transverse
Clinical narrative: Completely healthy athletic 16 y/o given menactra and 1 days later started with rapid onset LE paralysis with rapid progression to upper extremities, resulting in loss of function of bowel and bladder. Worked up and MRI confirmed transverse myelitis. Transported to highly specialized neurology at hospital. Initial Admission 9/13/22 and then transfer to hospital for 34 days: 9/14-10/19/2022.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Gait disturbance, Quality of life decreased, Seizure, Spinal fracture
Clinical narrative: Seizures; Fractured spine; Walking is difficult; Quality of life has declined; Allergic to the shot; This is a spontaneous report received from a contactable consumer, Program ID. The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Seizures"; SPINAL FRACTURE (medically significant), outcome "unknown", described as "Fractured spine"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Walking is difficult"; QUALITY OF LIFE DECREASED (non-serious), outcome "unknown", described as "Quality of life has declined"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergic to the shot". Per clinical course, the patient claimed that the vaccine has ruined his/her life. The patient had seizures and a fractured spine. Walking is difficult and the quality of life has declined. The patient wished he/she could turn back time for 2 years and decline the vaccine. The doctor has marked the patient's charts as allergic to the shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Tinnitus
Clinical narrative: AWAKENED FROM SLEEP BY AN EXTREMELY LOUD SIREN IN HEAD / TINNITUS; This spontaneous report received from a patient via a company representative concerned a 71 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was very good health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-AUG-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced awakened from sleep by an extremely loud siren in head/tinnitus. Laboratory data (dates unspecified) included: Laboratory test Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from awakened from sleep by an extremely loud siren in head / tinnitus. This report was non-serious.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19, DTAPIPV, FLU4, HEPA, MMRV
Symptoms: Product preparation issue
Clinical narrative: Incorrect dose of Pfizer Covid-19 vaccine administered due to incorrect mixing of diluent in vaccine vial.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19, DTAPIPV, FLU4, HEPA, MMRV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Incorrect dose of Pfizer Covid-19 vaccine administered due to incorrect mixing of diluent in vaccine vial.
Age: 9.0
Sex: F
Vaccine: COVID19, FLU4, IPV, MMRV, COVID19, FLU4, IPV, MMRV
Symptoms: Product preparation issue
Clinical narrative: Incorrect dose of Pfizer Covid-19 vaccine administered due to incorrect mixing of dilute in vaccine vial.
Age: 9.0
Sex: F
Vaccine: COVID19, FLU4, IPV, MMRV, COVID19, FLU4, IPV, MMRV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Incorrect dose of Pfizer Covid-19 vaccine administered due to incorrect mixing of dilute in vaccine vial.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19, FLU4
Symptoms: Product preparation issue
Clinical narrative: Incorrect dose of Pfizer Covid-19 vaccine administered due to incorrect mixing of diluent in vaccine vial.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19, FLU4
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Incorrect dose of Pfizer Covid-19 vaccine administered due to incorrect mixing of diluent in vaccine vial.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Incorrect dose of Pfizer Covid-19 vaccine administered due t incorrect mixing of dilute in vaccine vial. Spoke with POP after the visit-no adverse reactions were found.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Incorrect dose of Pfizer Covid-19 vaccine administered due t incorrect mixing of dilute in vaccine vial. Spoke with POP after the visit-no adverse reactions were found.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: On 08/20/2022 I started having vagina bleeding since I stopped period since January 2002. I talked to someone from Dr.'s office over the phone on 08/22/2022. On 08/23/2022 tested positive for COVID-19. On 9/12/2022 imagining pelvic ultrasound. On 09/28/2022 I had a 9:00AM appt. for Uterus Biopsy, did not get a complete test. Concerned about unknown nogal. 09/29/2022 had blood work done and came back normal. On 10/12/2022 to follow up with Dr. and she will be having D&C and Hysteroscopy tomorrow 12/16/2022. I am still having cramping.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, COVID-19, Muscle spasms, SARS-CoV-2 test positive, Ultrasound pelvis abnormal
Clinical narrative: On 08/20/2022 I started having vagina bleeding since I stopped period since January 2002. I talked to someone from Dr.'s office over the phone on 08/22/2022. On 08/23/2022 tested positive for COVID-19. On 9/12/2022 imagining pelvic ultrasound. On 09/28/2022 I had a 9:00AM appt. for Uterus Biopsy, did not get a complete test. Concerned about unknown nogal. 09/29/2022 had blood work done and came back normal. On 10/12/2022 to follow up with Dr. and she will be having D&C and Hysteroscopy tomorrow 12/16/2022. I am still having cramping.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Uterine disorder, Vaginal haemorrhage
Clinical narrative: On 08/20/2022 I started having vagina bleeding since I stopped period since January 2002. I talked to someone from Dr.'s office over the phone on 08/22/2022. On 08/23/2022 tested positive for COVID-19. On 9/12/2022 imagining pelvic ultrasound. On 09/28/2022 I had a 9:00AM appt. for Uterus Biopsy, did not get a complete test. Concerned about unknown nogal. 09/29/2022 had blood work done and came back normal. On 10/12/2022 to follow up with Dr. and she will be having D&C and Hysteroscopy tomorrow 12/16/2022. I am still having cramping.
Age: 85.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Anaemia, Asthenia, Atrioventricular block second degree, Blood thyroid stimulating hormone normal, COVID-19
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 11/23/2022 Discharge Date: 12/09/2022 COVID positive Date: 12/7/2022 Per hospital summary: "Pt is an 85-year-old male with PMH of recent COVID-19 infection, aortic stenosis status post replacement, pAFib, dementia, CAD status post CABG x3, ILD, HFpEF who presented on 11/23 with shortness of breath.  Chest x-ray was suspicious for pulmonary edema versus pneumonia.  He was started on empiric Rocephin and doxycycline for CAP coverage.  He was transferred to the intensive care unit after developing symptomatic bradycardia that required transvenous pacing.  His clinical status improved after permanent pacemaker procedure on 11/25. Developed worsening shortness of breath secondary to fluid overload.  Symptoms improved with Lasix.  Developed AKI while on the Lasix.  Nephrology was consulted. Urology consulted for hematuria.  Foley was placed and hematuria resolved.     Plan was to transition to a rehab given patient was medically optimized.  However developed significant orthostatic hypotension which started on 12/01/2022 and worsening renal function likely from overdiuresis.  Midodrine was added the patient continued to have significant orthostatic hypotension limiting therapy.  Hospice was consulted for informational meeting.   Consults: EP Critical care Nephrology Palliative Urology "   Interim hospital course:  Patient coming in with shortness of breath, initially treated for community-acquired pneumonia transfer to the intensive care unit initially for symptomatic bradycardia other required pacing, ultimately patient underwent pacemaker placement 11-25 developed fluid overload and improved with Lasix administration subsequently developing Aki  which also improved prior to discharge.  Urology was consulted for hematuria, Foley catheter was placed with resolution patient initial plan was transition to rehab however on further goals of care after worsening hypotension on 12/01 and midodrine initiation goals of care were further discussed and patient was open to hospice informational meeting.  Discussion had with Hospice and decision was made to transition to home hospice with discharge on 12/09/2022 in medically stable condition.  Patient to follow-up in enroll in Hospice on return home.  Previous VAERS submitted  906617
Age: 85.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Chest X-ray abnormal, Condition aggravated, Coronary artery bypass, Coronary artery disease, Diastolic dysfunction
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 11/23/2022 Discharge Date: 12/09/2022 COVID positive Date: 12/7/2022 Per hospital summary: "Pt is an 85-year-old male with PMH of recent COVID-19 infection, aortic stenosis status post replacement, pAFib, dementia, CAD status post CABG x3, ILD, HFpEF who presented on 11/23 with shortness of breath.  Chest x-ray was suspicious for pulmonary edema versus pneumonia.  He was started on empiric Rocephin and doxycycline for CAP coverage.  He was transferred to the intensive care unit after developing symptomatic bradycardia that required transvenous pacing.  His clinical status improved after permanent pacemaker procedure on 11/25. Developed worsening shortness of breath secondary to fluid overload.  Symptoms improved with Lasix.  Developed AKI while on the Lasix.  Nephrology was consulted. Urology consulted for hematuria.  Foley was placed and hematuria resolved.     Plan was to transition to a rehab given patient was medically optimized.  However developed significant orthostatic hypotension which started on 12/01/2022 and worsening renal function likely from overdiuresis.  Midodrine was added the patient continued to have significant orthostatic hypotension limiting therapy.  Hospice was consulted for informational meeting.   Consults: EP Critical care Nephrology Palliative Urology "   Interim hospital course:  Patient coming in with shortness of breath, initially treated for community-acquired pneumonia transfer to the intensive care unit initially for symptomatic bradycardia other required pacing, ultimately patient underwent pacemaker placement 11-25 developed fluid overload and improved with Lasix administration subsequently developing Aki  which also improved prior to discharge.  Urology was consulted for hematuria, Foley catheter was placed with resolution patient initial plan was transition to rehab however on further goals of care after worsening hypotension on 12/01 and midodrine initiation goals of care were further discussed and patient was open to hospice informational meeting.  Discussion had with Hospice and decision was made to transition to home hospice with discharge on 12/09/2022 in medically stable condition.  Patient to follow-up in enroll in Hospice on return home.  Previous VAERS submitted  906617
Age: 85.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Hypoxia, Laboratory test abnormal
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 11/23/2022 Discharge Date: 12/09/2022 COVID positive Date: 12/7/2022 Per hospital summary: "Pt is an 85-year-old male with PMH of recent COVID-19 infection, aortic stenosis status post replacement, pAFib, dementia, CAD status post CABG x3, ILD, HFpEF who presented on 11/23 with shortness of breath.  Chest x-ray was suspicious for pulmonary edema versus pneumonia.  He was started on empiric Rocephin and doxycycline for CAP coverage.  He was transferred to the intensive care unit after developing symptomatic bradycardia that required transvenous pacing.  His clinical status improved after permanent pacemaker procedure on 11/25. Developed worsening shortness of breath secondary to fluid overload.  Symptoms improved with Lasix.  Developed AKI while on the Lasix.  Nephrology was consulted. Urology consulted for hematuria.  Foley was placed and hematuria resolved.     Plan was to transition to a rehab given patient was medically optimized.  However developed significant orthostatic hypotension which started on 12/01/2022 and worsening renal function likely from overdiuresis.  Midodrine was added the patient continued to have significant orthostatic hypotension limiting therapy.  Hospice was consulted for informational meeting.   Consults: EP Critical care Nephrology Palliative Urology "   Interim hospital course:  Patient coming in with shortness of breath, initially treated for community-acquired pneumonia transfer to the intensive care unit initially for symptomatic bradycardia other required pacing, ultimately patient underwent pacemaker placement 11-25 developed fluid overload and improved with Lasix administration subsequently developing Aki  which also improved prior to discharge.  Urology was consulted for hematuria, Foley catheter was placed with resolution patient initial plan was transition to rehab however on further goals of care after worsening hypotension on 12/01 and midodrine initiation goals of care were further discussed and patient was open to hospice informational meeting.  Discussion had with Hospice and decision was made to transition to home hospice with discharge on 12/09/2022 in medically stable condition.  Patient to follow-up in enroll in Hospice on return home.  Previous VAERS submitted  906617
Age: 85.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Leukocytosis, Lung disorder, Pulmonary fibrosis, SARS-CoV-2 test positive, Thrombocytopenia
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 11/23/2022 Discharge Date: 12/09/2022 COVID positive Date: 12/7/2022 Per hospital summary: "Pt is an 85-year-old male with PMH of recent COVID-19 infection, aortic stenosis status post replacement, pAFib, dementia, CAD status post CABG x3, ILD, HFpEF who presented on 11/23 with shortness of breath.  Chest x-ray was suspicious for pulmonary edema versus pneumonia.  He was started on empiric Rocephin and doxycycline for CAP coverage.  He was transferred to the intensive care unit after developing symptomatic bradycardia that required transvenous pacing.  His clinical status improved after permanent pacemaker procedure on 11/25. Developed worsening shortness of breath secondary to fluid overload.  Symptoms improved with Lasix.  Developed AKI while on the Lasix.  Nephrology was consulted. Urology consulted for hematuria.  Foley was placed and hematuria resolved.     Plan was to transition to a rehab given patient was medically optimized.  However developed significant orthostatic hypotension which started on 12/01/2022 and worsening renal function likely from overdiuresis.  Midodrine was added the patient continued to have significant orthostatic hypotension limiting therapy.  Hospice was consulted for informational meeting.   Consults: EP Critical care Nephrology Palliative Urology "   Interim hospital course:  Patient coming in with shortness of breath, initially treated for community-acquired pneumonia transfer to the intensive care unit initially for symptomatic bradycardia other required pacing, ultimately patient underwent pacemaker placement 11-25 developed fluid overload and improved with Lasix administration subsequently developing Aki  which also improved prior to discharge.  Urology was consulted for hematuria, Foley catheter was placed with resolution patient initial plan was transition to rehab however on further goals of care after worsening hypotension on 12/01 and midodrine initiation goals of care were further discussed and patient was open to hospice informational meeting.  Discussion had with Hospice and decision was made to transition to home hospice with discharge on 12/09/2022 in medically stable condition.  Patient to follow-up in enroll in Hospice on return home.  Previous VAERS submitted  906617
Age: 85.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Acute kidney injury, Bladder catheterisation, Bradycardia, Cardiac pacemaker insertion, Chest X-ray abnormal
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 11/23/2022 Discharge Date: 12/09/2022 COVID positive Date: 12/7/2022 Per hospital summary: "Pt is an 85-year-old male with PMH of recent COVID-19 infection, aortic stenosis status post replacement, pAFib, dementia, CAD status post CABG x3, ILD, HFpEF who presented on 11/23 with shortness of breath.  Chest x-ray was suspicious for pulmonary edema versus pneumonia.  He was started on empiric Rocephin and doxycycline for CAP coverage.  He was transferred to the intensive care unit after developing symptomatic bradycardia that required transvenous pacing.  His clinical status improved after permanent pacemaker procedure on 11/25. Developed worsening shortness of breath secondary to fluid overload.  Symptoms improved with Lasix.  Developed AKI while on the Lasix.  Nephrology was consulted. Urology consulted for hematuria.  Foley was placed and hematuria resolved.     Plan was to transition to a rehab given patient was medically optimized.  However developed significant orthostatic hypotension which started on 12/01/2022 and worsening renal function likely from overdiuresis.  Midodrine was added the patient continued to have significant orthostatic hypotension limiting therapy.  Hospice was consulted for informational meeting.   Consults: EP Critical care Nephrology Palliative Urology "   Interim hospital course:  Patient coming in with shortness of breath, initially treated for community-acquired pneumonia transfer to the intensive care unit initially for symptomatic bradycardia other required pacing, ultimately patient underwent pacemaker placement 11-25 developed fluid overload and improved with Lasix administration subsequently developing Aki  which also improved prior to discharge.  Urology was consulted for hematuria, Foley catheter was placed with resolution patient initial plan was transition to rehab however on further goals of care after worsening hypotension on 12/01 and midodrine initiation goals of care were further discussed and patient was open to hospice informational meeting.  Discussion had with Hospice and decision was made to transition to home hospice with discharge on 12/09/2022 in medically stable condition.  Patient to follow-up in enroll in Hospice on return home.  Previous VAERS submitted  906617
Age: 85.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Dyspnoea, Haematuria, Hypervolaemia, Hypotension, Intensive care
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 11/23/2022 Discharge Date: 12/09/2022 COVID positive Date: 12/7/2022 Per hospital summary: "Pt is an 85-year-old male with PMH of recent COVID-19 infection, aortic stenosis status post replacement, pAFib, dementia, CAD status post CABG x3, ILD, HFpEF who presented on 11/23 with shortness of breath.  Chest x-ray was suspicious for pulmonary edema versus pneumonia.  He was started on empiric Rocephin and doxycycline for CAP coverage.  He was transferred to the intensive care unit after developing symptomatic bradycardia that required transvenous pacing.  His clinical status improved after permanent pacemaker procedure on 11/25. Developed worsening shortness of breath secondary to fluid overload.  Symptoms improved with Lasix.  Developed AKI while on the Lasix.  Nephrology was consulted. Urology consulted for hematuria.  Foley was placed and hematuria resolved.     Plan was to transition to a rehab given patient was medically optimized.  However developed significant orthostatic hypotension which started on 12/01/2022 and worsening renal function likely from overdiuresis.  Midodrine was added the patient continued to have significant orthostatic hypotension limiting therapy.  Hospice was consulted for informational meeting.   Consults: EP Critical care Nephrology Palliative Urology "   Interim hospital course:  Patient coming in with shortness of breath, initially treated for community-acquired pneumonia transfer to the intensive care unit initially for symptomatic bradycardia other required pacing, ultimately patient underwent pacemaker placement 11-25 developed fluid overload and improved with Lasix administration subsequently developing Aki  which also improved prior to discharge.  Urology was consulted for hematuria, Foley catheter was placed with resolution patient initial plan was transition to rehab however on further goals of care after worsening hypotension on 12/01 and midodrine initiation goals of care were further discussed and patient was open to hospice informational meeting.  Discussion had with Hospice and decision was made to transition to home hospice with discharge on 12/09/2022 in medically stable condition.  Patient to follow-up in enroll in Hospice on return home.  Previous VAERS submitted  906617
Age: 85.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Orthostatic hypotension, Pneumonia, Pulmonary oedema, Renal impairment
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 11/23/2022 Discharge Date: 12/09/2022 COVID positive Date: 12/7/2022 Per hospital summary: "Pt is an 85-year-old male with PMH of recent COVID-19 infection, aortic stenosis status post replacement, pAFib, dementia, CAD status post CABG x3, ILD, HFpEF who presented on 11/23 with shortness of breath.  Chest x-ray was suspicious for pulmonary edema versus pneumonia.  He was started on empiric Rocephin and doxycycline for CAP coverage.  He was transferred to the intensive care unit after developing symptomatic bradycardia that required transvenous pacing.  His clinical status improved after permanent pacemaker procedure on 11/25. Developed worsening shortness of breath secondary to fluid overload.  Symptoms improved with Lasix.  Developed AKI while on the Lasix.  Nephrology was consulted. Urology consulted for hematuria.  Foley was placed and hematuria resolved.     Plan was to transition to a rehab given patient was medically optimized.  However developed significant orthostatic hypotension which started on 12/01/2022 and worsening renal function likely from overdiuresis.  Midodrine was added the patient continued to have significant orthostatic hypotension limiting therapy.  Hospice was consulted for informational meeting.   Consults: EP Critical care Nephrology Palliative Urology "   Interim hospital course:  Patient coming in with shortness of breath, initially treated for community-acquired pneumonia transfer to the intensive care unit initially for symptomatic bradycardia other required pacing, ultimately patient underwent pacemaker placement 11-25 developed fluid overload and improved with Lasix administration subsequently developing Aki  which also improved prior to discharge.  Urology was consulted for hematuria, Foley catheter was placed with resolution patient initial plan was transition to rehab however on further goals of care after worsening hypotension on 12/01 and midodrine initiation goals of care were further discussed and patient was open to hospice informational meeting.  Discussion had with Hospice and decision was made to transition to home hospice with discharge on 12/09/2022 in medically stable condition.  Patient to follow-up in enroll in Hospice on return home.  Previous VAERS submitted  906617
Age: 90.0
Sex: F
Vaccine: FLUA4, UNK
Symptoms: Injection site mass, Injection site vesicles
Clinical narrative: In the injection site... it started to discharge a liquid; Lump in the arm in the injection site; This spontaneous case was received on 09-Dec-2022, from a pharmacist via Communications (reference number: SEQW22-06378) and concerned a 90-years-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 29-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration: intramuscular, anatomical location: not reported) for prevention of influenza disease. The batch number reported was 346378 and expiration date was 14-Jun-2023.  On the same day, an unreported amount of time after receiving Fluad Quadrivalent, the patient experienced lump in the arm in the injection site.  On 30-Oct-2022, reported as 'in the following day', it started to discharge a liquid. The patient mentioned that she covered it with a band aid.  The outcome of the events was not reported, although stop date was reported as 'possibly 30-Oct-2022'.  The case was assessed as non-serious.  Company comment: A 90-year-old female patient experienced vaccination site mass on the same day after vaccination with the suspect Fluad Quadrivalent vaccine. Next day, the patient experienced vaccination site discharge. Information regarding the underlying medical history and concomitant medications has not been provided. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related for both events based on plausible temporal relationship.; Sender's Comments: A 90-year-old female patient experienced vaccination site mass on the same day after vaccination with the suspect Fluad Quadrivalent vaccine. Next day, the patient experienced vaccination site discharge. Information regarding the underlying medical history and concomitant medications has not been provided. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related for both events based on plausible temporal relationship.
Age: 90.0
Sex: F
Vaccine: FLUA4, UNK
Symptoms: Injection site discharge, Injection site mass
Clinical narrative: In the injection site... it started to discharge a liquid; Lump in the arm in the injection site; This spontaneous case was received on 09-Dec-2022, from a pharmacist via Communications (reference number: SEQW22-06378) and concerned a 90-years-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 29-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration: intramuscular, anatomical location: not reported) for prevention of influenza disease. The batch number reported was 346378 and expiration date was 14-Jun-2023.  On the same day, an unreported amount of time after receiving Fluad Quadrivalent, the patient experienced lump in the arm in the injection site.  On 30-Oct-2022, reported as 'in the following day', it started to discharge a liquid. The patient mentioned that she covered it with a band aid.  The outcome of the events was not reported, although stop date was reported as 'possibly 30-Oct-2022'.  The case was assessed as non-serious.  Company comment: A 90-year-old female patient experienced vaccination site mass on the same day after vaccination with the suspect Fluad Quadrivalent vaccine. Next day, the patient experienced vaccination site discharge. Information regarding the underlying medical history and concomitant medications has not been provided. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related for both events based on plausible temporal relationship.; Sender's Comments: A 90-year-old female patient experienced vaccination site mass on the same day after vaccination with the suspect Fluad Quadrivalent vaccine. Next day, the patient experienced vaccination site discharge. Information regarding the underlying medical history and concomitant medications has not been provided. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related for both events based on plausible temporal relationship.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion and reported VARIVAX that had undergone temperature excursion was administered to a patient; No additional AE reported; This spontaneous report was received from medical assistant and refers to an approximately 18-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-NOV-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) valid lot #U029496, expiration date: 21-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided). That vaccine experienced a temperature excursion (Product storage error). It was reported that there was a previous temperature excursion, which was -10 degrees Celsius (C) up to 8 C (-7.2C) for 7 hours 54 minutes and 0 seconds, and the current excursion was -10 C up to 8 C (0.1C) for 444 hours 0 minutes and 0 seconds (also reported as 442). No further information was provided. No additional adverse event was reported (No adverse event).
Age: 0.75
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE's; ROATAEQ was administered to a nine month old patient; This spontaneous report was received from a registered nurse and refers to a 9-month-old infant of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 28-NOV-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, quantity 1, lot # W002561, expiration date: 07-OCT-2023, administered for prophylaxis (strength, exact dose and route of administration were not provided) (Product administered to patient of inappropriate age).  No additional adverse event reported.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; Customer reported that a patient got an extra dose (4th dose) of GARDASIL 9. Patient received 1st dose of GARDASIL 9 on 8/10/2016, patient received the 2nd dose on 8/2/2021, 3rd dose on 8/3/2022 and an additional 4th dose on 11/21/2022. No additional; Patient received 1st dose of GARDASIL 9 on 8/10/2016, patient received the 2nd dose on 8/2/2021, 3rd dose on 8/3/2022 and an additional 4th dose on 11/21/2022.; This spontaneous report was received from a nurse (also reported as customer) and refers to a 20-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-AUG-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). The patient received the second dose on 02-AUG-2021 (Inappropriate schedule of vaccine administered) and the third dose on 03-AUG-2022. On 21-NOV-2022, the patient received an additional fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U031056, expiration date: 16-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (Extra dose administered). No additional adverse event reported.
Age: 1.08
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE's; The caller states that a medical assistant in her clinic gave a 13-month old child GARDASIL 9 instead of their scheduled PREVNAR 13 dose; The caller states that a medical assistant in her clinic gave a 13-month old child GARDASIL 9 instead of their scheduled PREVNAR 13 dose; This spontaneous report was received from a nurse and refers to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-NOV-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1775811, expiration date: 07-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided) (Drug use in unapproved age group) instead of their scheduled pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), lot # SM7207 and expiration date: 30-JUN-2024 (Wrong vaccine administered). No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; HCP reported ROTATEQ was administered after a temperature excursion to a patient on Nov 7, 2022.; This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 07-NOV-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally, lot number: U038854, expiration date: 20-APR-2023 (dose and dose number were not reported) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  The administered dose of the suspect vaccine experienced a temperature excursion of 33.9 degrees Fahrenheit for 2 hours. There was no previous reported temperature excursion. It was unknown, whether a digital data logger was involved.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2212USA000635:2212USA000635