chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Angiogram pulmonary abnormal, Asthenia, COVID-19, COVID-19 pneumonia
Clinical narrative: Patient is a 69 y.o. male with a history of Non-Hodgkin Lymphoma, DVT (off anticoagulation), HTN, Anemia who presented to Hospital 2/22/2023 with several hours of weakness, fatigue, cough, fever, and mechanical fall from which he was unable to stand after due to weakness. In ED: SARS-CoV-2 positive. Admitted due to hypoxia with evidence of Covid-19 pneumonia. Symptoms improved with decadron/remdesivir and supportive care. Did require low flow O2 for discharge.    1. COVID-19 pneumonia : Patient with fever cough fatigue and generalized weakness since 2/22/23 (0 days prior to admission). SARS-CoV-2 positive on 2/22/23. Patient is vaccinated.  CTPA 2/23/23: mild ground glass opacities bases, no PE. Dexamethasone 6mg PO x10 days (last dose 3/3/23). Started remdesivir IV x5 days (last dose 2/25/23 given planned discharge). Symptoms improved overall.  2. Acute hypoxic respiratory failure: Patient not on oxygen at home but requiring 2 L oxygen through nasal cannula.  Likely secondary to COVID.  Received steroid and remdesivir as above and supportive treatment. Required O2 for home-going (1L). Further weaning in outptient setting.  3. Mechanical Fall: No loss of consciousness, no head strike. PT/OT followed, patient and spouse declined HHC.    4. Mantle Cell Lymphoma: Followed by Dr. (Oncology), daignosed 3/2021, stage IV with marrow and splenic involvement on bendamustine and Rituximab. Last chemo ~10/2022, next dose rituxan due 2/24/23, will need to reschedule and follow up outpatient.  5. Chronic DVT: Diagnosed 3/2021. Venous duplex 5/2021 chronic left femoral to gastrocnemius venous thrombosis. Patient taken off Xarelto ~10/2022. 6. Chronic Iron Def Anemia: baseline Hgb ~10-12. Hgb of 12 (MCV 98) in ED.  7. Chronic Thrombocytopenia: baseline plt count ~100-200k. Plt of 106k in ED. Suspect due to lymphoma. Monitored. 8. Hypertension: by history, not on medications prior to admission. Monitored.  9. Osteoarthritis: Followed by Orthopedics s/p left knee steroid injection 1/17/23. Monitored. 10. Chronic Encephalopathy: Followed by Dr. (Neurology). Admitted to Facility 11/2022 for hallucinations and metabolic encephalopathy, negative workup, eventually resolved. Continued home Seroquel taper.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysstasia, Encephalopathy, Fall, Fatigue
Clinical narrative: Patient is a 69 y.o. male with a history of Non-Hodgkin Lymphoma, DVT (off anticoagulation), HTN, Anemia who presented to Hospital 2/22/2023 with several hours of weakness, fatigue, cough, fever, and mechanical fall from which he was unable to stand after due to weakness. In ED: SARS-CoV-2 positive. Admitted due to hypoxia with evidence of Covid-19 pneumonia. Symptoms improved with decadron/remdesivir and supportive care. Did require low flow O2 for discharge.    1. COVID-19 pneumonia : Patient with fever cough fatigue and generalized weakness since 2/22/23 (0 days prior to admission). SARS-CoV-2 positive on 2/22/23. Patient is vaccinated.  CTPA 2/23/23: mild ground glass opacities bases, no PE. Dexamethasone 6mg PO x10 days (last dose 3/3/23). Started remdesivir IV x5 days (last dose 2/25/23 given planned discharge). Symptoms improved overall.  2. Acute hypoxic respiratory failure: Patient not on oxygen at home but requiring 2 L oxygen through nasal cannula.  Likely secondary to COVID.  Received steroid and remdesivir as above and supportive treatment. Required O2 for home-going (1L). Further weaning in outptient setting.  3. Mechanical Fall: No loss of consciousness, no head strike. PT/OT followed, patient and spouse declined HHC.    4. Mantle Cell Lymphoma: Followed by Dr. (Oncology), daignosed 3/2021, stage IV with marrow and splenic involvement on bendamustine and Rituximab. Last chemo ~10/2022, next dose rituxan due 2/24/23, will need to reschedule and follow up outpatient.  5. Chronic DVT: Diagnosed 3/2021. Venous duplex 5/2021 chronic left femoral to gastrocnemius venous thrombosis. Patient taken off Xarelto ~10/2022. 6. Chronic Iron Def Anemia: baseline Hgb ~10-12. Hgb of 12 (MCV 98) in ED.  7. Chronic Thrombocytopenia: baseline plt count ~100-200k. Plt of 106k in ED. Suspect due to lymphoma. Monitored. 8. Hypertension: by history, not on medications prior to admission. Monitored.  9. Osteoarthritis: Followed by Orthopedics s/p left knee steroid injection 1/17/23. Monitored. 10. Chronic Encephalopathy: Followed by Dr. (Neurology). Admitted to Facility 11/2022 for hallucinations and metabolic encephalopathy, negative workup, eventually resolved. Continued home Seroquel taper.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin normal, Hallucination, Hypoxia, Iron deficiency anaemia, Lung opacity
Clinical narrative: Patient is a 69 y.o. male with a history of Non-Hodgkin Lymphoma, DVT (off anticoagulation), HTN, Anemia who presented to Hospital 2/22/2023 with several hours of weakness, fatigue, cough, fever, and mechanical fall from which he was unable to stand after due to weakness. In ED: SARS-CoV-2 positive. Admitted due to hypoxia with evidence of Covid-19 pneumonia. Symptoms improved with decadron/remdesivir and supportive care. Did require low flow O2 for discharge.    1. COVID-19 pneumonia : Patient with fever cough fatigue and generalized weakness since 2/22/23 (0 days prior to admission). SARS-CoV-2 positive on 2/22/23. Patient is vaccinated.  CTPA 2/23/23: mild ground glass opacities bases, no PE. Dexamethasone 6mg PO x10 days (last dose 3/3/23). Started remdesivir IV x5 days (last dose 2/25/23 given planned discharge). Symptoms improved overall.  2. Acute hypoxic respiratory failure: Patient not on oxygen at home but requiring 2 L oxygen through nasal cannula.  Likely secondary to COVID.  Received steroid and remdesivir as above and supportive treatment. Required O2 for home-going (1L). Further weaning in outptient setting.  3. Mechanical Fall: No loss of consciousness, no head strike. PT/OT followed, patient and spouse declined HHC.    4. Mantle Cell Lymphoma: Followed by Dr. (Oncology), daignosed 3/2021, stage IV with marrow and splenic involvement on bendamustine and Rituximab. Last chemo ~10/2022, next dose rituxan due 2/24/23, will need to reschedule and follow up outpatient.  5. Chronic DVT: Diagnosed 3/2021. Venous duplex 5/2021 chronic left femoral to gastrocnemius venous thrombosis. Patient taken off Xarelto ~10/2022. 6. Chronic Iron Def Anemia: baseline Hgb ~10-12. Hgb of 12 (MCV 98) in ED.  7. Chronic Thrombocytopenia: baseline plt count ~100-200k. Plt of 106k in ED. Suspect due to lymphoma. Monitored. 8. Hypertension: by history, not on medications prior to admission. Monitored.  9. Osteoarthritis: Followed by Orthopedics s/p left knee steroid injection 1/17/23. Monitored. 10. Chronic Encephalopathy: Followed by Dr. (Neurology). Admitted to Facility 11/2022 for hallucinations and metabolic encephalopathy, negative workup, eventually resolved. Continued home Seroquel taper.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Mantle cell lymphoma, Metabolic encephalopathy, Metastases to bone marrow, Metastases to spleen, Osteoarthritis
Clinical narrative: Patient is a 69 y.o. male with a history of Non-Hodgkin Lymphoma, DVT (off anticoagulation), HTN, Anemia who presented to Hospital 2/22/2023 with several hours of weakness, fatigue, cough, fever, and mechanical fall from which he was unable to stand after due to weakness. In ED: SARS-CoV-2 positive. Admitted due to hypoxia with evidence of Covid-19 pneumonia. Symptoms improved with decadron/remdesivir and supportive care. Did require low flow O2 for discharge.    1. COVID-19 pneumonia : Patient with fever cough fatigue and generalized weakness since 2/22/23 (0 days prior to admission). SARS-CoV-2 positive on 2/22/23. Patient is vaccinated.  CTPA 2/23/23: mild ground glass opacities bases, no PE. Dexamethasone 6mg PO x10 days (last dose 3/3/23). Started remdesivir IV x5 days (last dose 2/25/23 given planned discharge). Symptoms improved overall.  2. Acute hypoxic respiratory failure: Patient not on oxygen at home but requiring 2 L oxygen through nasal cannula.  Likely secondary to COVID.  Received steroid and remdesivir as above and supportive treatment. Required O2 for home-going (1L). Further weaning in outptient setting.  3. Mechanical Fall: No loss of consciousness, no head strike. PT/OT followed, patient and spouse declined HHC.    4. Mantle Cell Lymphoma: Followed by Dr. (Oncology), daignosed 3/2021, stage IV with marrow and splenic involvement on bendamustine and Rituximab. Last chemo ~10/2022, next dose rituxan due 2/24/23, will need to reschedule and follow up outpatient.  5. Chronic DVT: Diagnosed 3/2021. Venous duplex 5/2021 chronic left femoral to gastrocnemius venous thrombosis. Patient taken off Xarelto ~10/2022. 6. Chronic Iron Def Anemia: baseline Hgb ~10-12. Hgb of 12 (MCV 98) in ED.  7. Chronic Thrombocytopenia: baseline plt count ~100-200k. Plt of 106k in ED. Suspect due to lymphoma. Monitored. 8. Hypertension: by history, not on medications prior to admission. Monitored.  9. Osteoarthritis: Followed by Orthopedics s/p left knee steroid injection 1/17/23. Monitored. 10. Chronic Encephalopathy: Followed by Dr. (Neurology). Admitted to Facility 11/2022 for hallucinations and metabolic encephalopathy, negative workup, eventually resolved. Continued home Seroquel taper.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased, Pyrexia, SARS-CoV-2 test positive, Thrombocytopenia
Clinical narrative: Patient is a 69 y.o. male with a history of Non-Hodgkin Lymphoma, DVT (off anticoagulation), HTN, Anemia who presented to Hospital 2/22/2023 with several hours of weakness, fatigue, cough, fever, and mechanical fall from which he was unable to stand after due to weakness. In ED: SARS-CoV-2 positive. Admitted due to hypoxia with evidence of Covid-19 pneumonia. Symptoms improved with decadron/remdesivir and supportive care. Did require low flow O2 for discharge.    1. COVID-19 pneumonia : Patient with fever cough fatigue and generalized weakness since 2/22/23 (0 days prior to admission). SARS-CoV-2 positive on 2/22/23. Patient is vaccinated.  CTPA 2/23/23: mild ground glass opacities bases, no PE. Dexamethasone 6mg PO x10 days (last dose 3/3/23). Started remdesivir IV x5 days (last dose 2/25/23 given planned discharge). Symptoms improved overall.  2. Acute hypoxic respiratory failure: Patient not on oxygen at home but requiring 2 L oxygen through nasal cannula.  Likely secondary to COVID.  Received steroid and remdesivir as above and supportive treatment. Required O2 for home-going (1L). Further weaning in outptient setting.  3. Mechanical Fall: No loss of consciousness, no head strike. PT/OT followed, patient and spouse declined HHC.    4. Mantle Cell Lymphoma: Followed by Dr. (Oncology), daignosed 3/2021, stage IV with marrow and splenic involvement on bendamustine and Rituximab. Last chemo ~10/2022, next dose rituxan due 2/24/23, will need to reschedule and follow up outpatient.  5. Chronic DVT: Diagnosed 3/2021. Venous duplex 5/2021 chronic left femoral to gastrocnemius venous thrombosis. Patient taken off Xarelto ~10/2022. 6. Chronic Iron Def Anemia: baseline Hgb ~10-12. Hgb of 12 (MCV 98) in ED.  7. Chronic Thrombocytopenia: baseline plt count ~100-200k. Plt of 106k in ED. Suspect due to lymphoma. Monitored. 8. Hypertension: by history, not on medications prior to admission. Monitored.  9. Osteoarthritis: Followed by Orthopedics s/p left knee steroid injection 1/17/23. Monitored. 10. Chronic Encephalopathy: Followed by Dr. (Neurology). Admitted to Facility 11/2022 for hallucinations and metabolic encephalopathy, negative workup, eventually resolved. Continued home Seroquel taper.
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: On 03/06/2023, I started coughing with congestion and a low-grade fever. I took an at-home COVID-19 test on 03/07/2023 which came back positive. I called my doctor immediately after where my husband and I were both prescribed Paxlovid for treatment since we both tested positive. We were told to start taking our first dose immediately once picking up our prescription. We completed our prescription, and I'm currently doing well but still testing positive unfortunately. My symptoms are practically gone at this point.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product administration error
Clinical narrative: Administration Error: Patient received first dose of Sputnik out of country, second dose of AstraZenica. According to CDC guidelines, since Sputnik is not EUA approved by CDC or WHO, patient should have received monovalent mRNA dose. Instead, a bivalent dose was administered
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I got covid 01/09/2023.  I was prescribed Paxlovid.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Electrocardiogram abnormal, Headache, Insomnia, Palpitations
Clinical narrative: 11/21/2022 I tested positive for COVID-19 I had a massive headache, sinus pain and fever. I called my Physician and was prescribed Paxlovid. I was feeling alot better after 2 days. 03/02/2023 I started getting heart palpitations and it was hard to sleep or rest. I  went to clinic and had an EKG  it was noted that I was in  PAC . Physician suggested that I may have autonomic neuropathy which he has seen post vaccine. I have a follow up with a Cardiologist for a Holter Monitor in August.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test positive, Sinus pain, Supraventricular extrasystoles
Clinical narrative: 11/21/2022 I tested positive for COVID-19 I had a massive headache, sinus pain and fever. I called my Physician and was prescribed Paxlovid. I was feeling alot better after 2 days. 03/02/2023 I started getting heart palpitations and it was hard to sleep or rest. I  went to clinic and had an EKG  it was noted that I was in  PAC . Physician suggested that I may have autonomic neuropathy which he has seen post vaccine. I have a follow up with a Cardiologist for a Holter Monitor in August.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Blood test abnormal, Chronic kidney disease, Diarrhoea, Dizziness, Headache
Clinical narrative: After I got the fifth dose of the Pfizer COVID-19 vaccine, I experienced fever, muscle aches, diarrhea, and headaches. These symptoms lasted for four days. I took naproxen to treat the symptoms, and it helped. Later on, I went in for my yearly physical. During the physical, I took a blood test, which indicated that my thyroid activity was out of the normal range; I was told that I had hypothyroidism and was prescribed levothyroxine (0.05 mg). The NP then did a follow-up to make sure I didn't develop hyperthyroidism, so she ordered a follow-up blood test two weeks after I was prescribed the levothyroxine. The results indicated that everything was fine and that the medication was working. At the time she prescribed the medication, she took my BP, which was very high. Because of this, the NP sent me home with a chart with instructions on how to do at-home BP testing. My BP continued to be high, so after about three weeks, I called my doctor's office and asked to be put on BP medication. I was then prescribed lisinopril. I am currently taking 30 mg of lisinopril; I started with 5 mg. About three weeks after starting the lisinopril, I went back to the doctor, because I was experiencing dizziness and nausea when hiking. The doctor ran another blood test. After getting the results, my doctor diagnosed me with stage 3 chronic kidney disease. I am due to undergo a renal ultrasound in the very near future. With the levothyroxine, I have noticed a positive change. I am now less lethargic and more active. However, I am concerned about the lisinopril and whether it may be negatively affecting the health of my kidneys, as there are contraindications.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Hypertension, Hypothyroidism, Lethargy, Myalgia, Nausea
Clinical narrative: After I got the fifth dose of the Pfizer COVID-19 vaccine, I experienced fever, muscle aches, diarrhea, and headaches. These symptoms lasted for four days. I took naproxen to treat the symptoms, and it helped. Later on, I went in for my yearly physical. During the physical, I took a blood test, which indicated that my thyroid activity was out of the normal range; I was told that I had hypothyroidism and was prescribed levothyroxine (0.05 mg). The NP then did a follow-up to make sure I didn't develop hyperthyroidism, so she ordered a follow-up blood test two weeks after I was prescribed the levothyroxine. The results indicated that everything was fine and that the medication was working. At the time she prescribed the medication, she took my BP, which was very high. Because of this, the NP sent me home with a chart with instructions on how to do at-home BP testing. My BP continued to be high, so after about three weeks, I called my doctor's office and asked to be put on BP medication. I was then prescribed lisinopril. I am currently taking 30 mg of lisinopril; I started with 5 mg. About three weeks after starting the lisinopril, I went back to the doctor, because I was experiencing dizziness and nausea when hiking. The doctor ran another blood test. After getting the results, my doctor diagnosed me with stage 3 chronic kidney disease. I am due to undergo a renal ultrasound in the very near future. With the levothyroxine, I have noticed a positive change. I am now less lethargic and more active. However, I am concerned about the lisinopril and whether it may be negatively affecting the health of my kidneys, as there are contraindications.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Pyrexia
Clinical narrative: After I got the fifth dose of the Pfizer COVID-19 vaccine, I experienced fever, muscle aches, diarrhea, and headaches. These symptoms lasted for four days. I took naproxen to treat the symptoms, and it helped. Later on, I went in for my yearly physical. During the physical, I took a blood test, which indicated that my thyroid activity was out of the normal range; I was told that I had hypothyroidism and was prescribed levothyroxine (0.05 mg). The NP then did a follow-up to make sure I didn't develop hyperthyroidism, so she ordered a follow-up blood test two weeks after I was prescribed the levothyroxine. The results indicated that everything was fine and that the medication was working. At the time she prescribed the medication, she took my BP, which was very high. Because of this, the NP sent me home with a chart with instructions on how to do at-home BP testing. My BP continued to be high, so after about three weeks, I called my doctor's office and asked to be put on BP medication. I was then prescribed lisinopril. I am currently taking 30 mg of lisinopril; I started with 5 mg. About three weeks after starting the lisinopril, I went back to the doctor, because I was experiencing dizziness and nausea when hiking. The doctor ran another blood test. After getting the results, my doctor diagnosed me with stage 3 chronic kidney disease. I am due to undergo a renal ultrasound in the very near future. With the levothyroxine, I have noticed a positive change. I am now less lethargic and more active. However, I am concerned about the lisinopril and whether it may be negatively affecting the health of my kidneys, as there are contraindications.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: swelling and tenderness in left underarm. patient came into clinic for assessment with provider. Patient left clinic in good condition with instruction to return if symptoms worsen as ultrasound may be needed. provider states it may be lymphadenopathy, axillary
Age: 38.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Chest X-ray normal, Cough, Discomfort, Ear pain, Nasal congestion
Clinical narrative: I had my vaccination on 09/21/2022. I started to experience coughing stuffy nose congestions and pressure on 03/06/2023.  On 03/13/2023 I had a Chest Xray. I did start to have horrible ear pain. I did go to the urgent care on 03/18/2023 and was prescribed a Z pack and cough medication. I have not had any drainage from my ear and I will be contacting my primary doctor for a referral to ENT.
Age: 38.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Respiratory tract congestion
Clinical narrative: I had my vaccination on 09/21/2022. I started to experience coughing stuffy nose congestions and pressure on 03/06/2023.  On 03/13/2023 I had a Chest Xray. I did start to have horrible ear pain. I did go to the urgent care on 03/18/2023 and was prescribed a Z pack and cough medication. I have not had any drainage from my ear and I will be contacting my primary doctor for a referral to ENT.
Age: 1.33
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Flushing, Heart rate increased, Hypersensitivity, Urticaria
Clinical narrative: Patient was seen for 16 Month WCC, He received varicella and PCV 13 30 minutes after patient was noted to severe allergic where his skin flushed, heart rate increased with hives on his face, chest and abdomen. No airway compromise or edema noted0 Patient was given Epi Pen and Benadryl. Provider followed up via telephone with mom on 03/22/2023.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Productive cough, SARS-CoV-2 test positive, Sputum discoloured
Clinical narrative: I had a cough, drainage in throat, and headache. By Thursday the cough got deeper, and I had dark colored mucus. I tested positive for COVID-19 on February 16, 2023. I spoke to my doctor, and she prescribed me Molnupiravir 200mg for 5 days. By the second day I started to feel better.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Upper-airway cough syndrome
Clinical narrative: I had a cough, drainage in throat, and headache. By Thursday the cough got deeper, and I had dark colored mucus. I tested positive for COVID-19 on February 16, 2023. I spoke to my doctor, and she prescribed me Molnupiravir 200mg for 5 days. By the second day I started to feel better.
Sex: U
Vaccine: COVID19
Symptoms: Anaemia, Atrophy, B-cell lymphoma, Death, Heart rate increased
Clinical narrative: B cell lymphoma, atrophy, anemia, blockage in small intestine, fast heart rate, death
Sex: U
Vaccine: COVID19
Symptoms: Small intestinal obstruction
Clinical narrative: B cell lymphoma, atrophy, anemia, blockage in small intestine, fast heart rate, death
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Mother described patient had hives on hands shortly after getting home. mother applied Benadryl cream on hives and resolved within a short time.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphonia, Cough, Oropharyngeal pain, Paranasal sinus discomfort, SARS-CoV-2 test negative
Clinical narrative: On March 20, 2023, I began having a scratchy throat and then I lost my voice.  I had some sinus pressure and a sore throat with a dry cough.  I contacted the doctor and was prescribed antibiotics and an inhaler.  I am feeling a bit better, but I have a lingering cough.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat irritation, Urine analysis normal
Clinical narrative: On March 20, 2023, I began having a scratchy throat and then I lost my voice.  I had some sinus pressure and a sore throat with a dry cough.  I contacted the doctor and was prescribed antibiotics and an inhaler.  I am feeling a bit better, but I have a lingering cough.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza virus test negative, Nasal congestion, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: It started with a cough, congestion in my nose, my throat was getting tight. I decided to get a COVID-19 test on 02/08/2023 and it was positive. I seen my prescriber at Urgent care and I was prescribed Paxlovid.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: It started with a cough, congestion in my nose, my throat was getting tight. I decided to get a COVID-19 test on 02/08/2023 and it was positive. I seen my prescriber at Urgent care and I was prescribed Paxlovid.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Went to facility to vaccinate residents in rooms. The nurse assured us that she had checked everyone's vaccination status and that they were eligible for a bivalent booster.  Nurse had a consent form signed by the patient's daughter to receive the vaccine.  Patient is unable to make decisions on her own and her primary language is different. Patient had no adverse effects from the vaccine. When we returned to our office to enter patient info I got an alert that this patient has already had her bivalent booster in January, thus was not eligible to receive the vaccine today.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had severe fatigue, mild cough, and low grade fever. I tested positive for COVID-19 and called my doctor. She prescribed me Paxlovid and it made me feel worse. I still have fatigue.
Age: 53.0
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to patient outside of accepted age range (9-45)
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Feeling abnormal, Malaise, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: tested positive after feeling punk. Rx plaxovid. felt better after 2 days. Was running fever of 100.5F on first day. had one half day rebound of fever and malaise on Saturday, 18 Feb. Fine the next day. Tested positive until Feb 21
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Electroencephalogram, Hypoaesthesia, Laboratory test, Magnetic resonance imaging
Clinical narrative: Muscle weakness, numbness and tingling, possible Gullaine Barre or myasthenia gravies
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Paraesthesia, Urine analysis
Clinical narrative: Muscle weakness, numbness and tingling, possible Gullaine Barre or myasthenia gravies
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Started with sore arm at site if injection.  Continues  with pain going down arm to wrist. Also loss of mobility. Cannot lift arm above shoulder without pain. Hurts and aches while at rest, at night in bed.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This solicited report received from a patient via company representative via: Janssen for XARELTO concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: deep vein thrombosis, and other pre-existing medical conditions included: The patient had no known allergies. The patient was treated with rivaroxaban (film-coated tablet, route of admin, and batch number were not reported, expiry: unknown) (strength 20 mg), dose, frequency, and therapy dates were not reported for deep vein thrombosis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of rivaroxaban was not changed. The outcome of blood clot was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clot was not related; and between rivaroxaban, and blood clot was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230361841-blood clot.. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.  XARELTO-blood clot. The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Feeling hot
Clinical narrative: Pt states less than 5 minutes after receiving the Moderna (2nd dose) vaccine she felt itching in her ear (Right) and she felt warm on the same side the injection was given. Nurse was notified by vaccine team of pt reaction. Safety maintained. Vaccine team notified RN Lead immediately at approximately 2:53 pm. Vitals were taken at 2:55pm B/P 170/100 HR 84. Pt states she had not taken her B/P medication (lisinopril) this morning. Pt was informed by RN monitored for 30 minutes, pt agreed. before pt left BP 170/102, feels fine; pt exited bldg.
Age: 14.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 14.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 16.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 16.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Pain, Pyrexia
Clinical narrative: Body aches, fever, chills, head ache and chest pain
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Infertility
Clinical narrative: After receiving the first and second vaccine, I did not have a menses for 3 months. Still today, I have not been able to conceive a child after many attempts.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Hyperhidrosis, Hypersomnia, Loss of personal independence in daily activities
Clinical narrative: My last period was October 2021  just one month after my second dose of the Covid vaccine. I?ve also developed huge lymph nodes in my neck and am constantly exhausted. I have trouble breathing. I wake up pouring sweat. I could sleep for days. My sons have not missed a day of school until this year. So far they have missed 11 days and it?s 100% because I literally cannot get out of bed. Thanks to you and the government forcing me to get vaccinated, I?m now being tested for cancer.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Mobility decreased
Clinical narrative: My last period was October 2021  just one month after my second dose of the Covid vaccine. I?ve also developed huge lymph nodes in my neck and am constantly exhausted. I have trouble breathing. I wake up pouring sweat. I could sleep for days. My sons have not missed a day of school until this year. So far they have missed 11 days and it?s 100% because I literally cannot get out of bed. Thanks to you and the government forcing me to get vaccinated, I?m now being tested for cancer.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Brain fog, Chest pain, Cough, Headache
Clinical narrative: chest pain / Heart pain, Lethargy , Brain fog ,coughing , insomnia , headache , nausea
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Lethargy, Nausea
Clinical narrative: chest pain / Heart pain, Lethargy , Brain fog ,coughing , insomnia , headache , nausea
Sex: U
Vaccine: PNC15, PNC15, PNC15, PNC15
Symptoms: Syringe issue
Clinical narrative: Inbound call from nurse reporting product quality issue with 3 broken VAXNEUVANCE syringes. All affected products were from the same lot and in the same tray. Caller is willing to send pictures and was provided e-mail for pictures. Products are; No adverse event; This spontaneous report was received from a nurse and refers to an unknown patient (age and gender was not provided). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  The nurse reported that three total syringes of  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 milliliter injection, unk, lots #W027250, with expiration date: 09-JUL-2024, administered for prophylaxis (route of administration was not provided), wereaffected. One was broken at the luer lock attachment. the luer lock attachment has completely broken away from the barrel and the vaccine has leaked out. the other two syringes have crushed barrels  For this complaint the nurse reported a total of 3 broken syringes, 2 broken finger flanges and 1 broken hub/tip. Site received 4 syringes, 3 have broken finger flanges and 1 has a broken finger flange and a broken hub/tip.  It was also confirmed that there were 4 total pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringes that were broken and all 4 of those were sent back. The nurse also reported that all 4 vaccines were damaged like that when they received them. None of the damage occurred during shipment back. No additional information provided.  This case was considered non-valid due to lack of patient identifiers.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Therapy interrupted
Clinical narrative: initiated GARDASIL 9 around age 24 and received his first dose in November of 2021 / received second dose in November 2022; No other adverse events reported.; This spontaneous report has been received from a registered pharmacist (R.Ph.) referring to a 26-year-old male patient. Information of concomitant medications, pertinent medical history, concurrent conditions and drug reactions/allergies was not reported.   The reporter was inquiring about interrupted series for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient initiated hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at around age 24 and in November 2021, the patient received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot#, expiration date, route of administration and anatomical location were unknown) for prophylaxis. In November 2022, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, lot#, expiration date, route of administration and anatomical location were unknown) (inappropriate schedule of product administration). The patient had yet to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No other adverse events reported (no adverse event). No product quality. No further information provided.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Nurse reported that a 14 year old patient received PROQUAD.; No additional AEs were reported; This spontaneous report has been received from a registered nurse (R.N.) referring to a 14-year-old patient of unknown gender. Information of concomitant medications, pertinent medical history, concurrent conditions and drug reactions/allergies was not reported.  On an unknown date, the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (1 dosage form (reported as 1 dose), strength, lot#, expiration date, route of administration and anatomical location were unknown) for prophylaxis (product administered to patient of inappropriate age). No additional AEs were reported (no adverse event). No further information provided. No PQC.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; patient was accidently administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On 27-FEB-2023, the patient was accidently administered an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, a dosage form, once, lot #U021995, expiration date: 13-JAN-2023, administered for prophylaxis (strength and route of administration were not provided) (expired product administered). The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) had no prior temperature excursions. No additional adverse event reported.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other adverse events reported.; ROTATEQ series being initiated for an infant at 20 weeks of age; This spontaneous report has been received from a licensed vocational nurse (L.V.N.) referring to a 20-week-old patient of unknown gender. Information of concomitant medications, pertinent medical history, concurrent conditions and drug reactions/allergies was not reported.  Due to other issues, the patient did not receive his/her first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (1 dosage form (reported as 1 dose), strength, lot#, expiration date were unknown) orally for prophylaxis until 08-MAR-2023 (product administered to patient of inappropriate age). No other adverse events were reported (no adverse event). No product quality complaint. No further information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient received improperly stored vaccine; This spontaneous report was received from a healthcare professional and referred to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-MAR-2023, the patient was vaccinated with improperly stored vaccine, varicella virus vaccine live (oka/merck) (VARIVAX) (1 dosage form, lot #w008711, expiration date: 14-MAR-2024; anatomical location, strength, and route were not reported) for prophylaxis (Product storage error). There was no adverse event. The temperature was -3.2 degree Celsius. The time frame was 3 hours. There was no previous temperature excursion.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; an expired dose of VAQTA to a patient on 10MAR2023; This spontaneous report was received from a Medical Assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 10-MAR-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dosage form, lot #U021561, expiration date: 14-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). The reporter confirmed the product was not involved in a temperature excursion and was stored according to the recommended storage range until administration. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improperly stored VARIVAX was inadvertently administered; This spontaneous report was received from a nurse and referred to a patient with unknown age and gender. The patient's concurrent conditions, concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.  On 07-MAR-2023, varicella virus vaccine live (oka/merck) (VARIVAX) was improperly stored (product storage error). Temperature was 5.8 Fahrenheit degree (F). Time frame was 2 minutes. Previous temperature excursion did not occur. On an unknown date in March 2023, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # W016746 has been verified to be a valid lot number, expiration date was reported as 23-MAY-2024, dose, route and anatomical location were not provided) for prophylaxis. No additional adverse event (AE) details (No adverse event).  This was one of the two report due to the same reporter.; Sender's Comments:  US-009507513-2303USA005125:
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 4 year old patient experienced severe swelling to left lower extremity; HCP reported that swelling was twice size of right extremity with hard, red, and hot skin; HCP reported that swelling was twice size of right extremity with hard, red, and hot skin; HCP reported that swelling was twice size of right extremity with hard, red, and hot skin; This spontaneous report was received from a physician via a company employee referring to a 4-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were unknown.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 ml/once, administered subcutaneously on left thigh for prophylaxis (strength was not provided, lot # and expiration date were unknown).  In approximately June 2022 (also reported as approximately 8 months ago), the patient experienced severe swelling to left lower extremity after receiving measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (peripheral swelling). The reporter reported that swelling was twice size of right extremity with hard, red, and hot skin (skin induration; erythema; skin warm), and that reaction lasted 2 weeks before resolving with treatment of diphenhydramine (BENADRYL), ibuprofen (MOTRIN), steroids and compression. The outcome of all events was reported as recovered and the recovery date was reported as unknown. The action taken with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) regarding all events was not applicable.   The causal relationship between all events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE details or PQC.; an improperly stored VARIVAX was inadvertently administered.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W016746, expiration date: 23-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided) inadvertently that experienced a temperature excursion (product storage error). No additional adverse event details.  The vaccine experienced a temperature excursion of 5.8 degrees Fahrenheit (F) for 2 minutes. There was no previous temperature excursion.  This was one of the two report due to the same reporter.; Sender's Comments:  US-009507513-2303USA005072:02352904
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; HCP calling to report that a patient was administered an expired vaccine of VAQTA.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 15-MAR-2023, the patient was vaccinated an expired vaccine of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 ml/ 1x (once), lot #U036184, expiration date: 02-MAR-2023, administered for prophylaxis (strength and route of administration were not provided) (expired product administered). No previous temperature excursion. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details; a patient was inadvertently administered an expired VAQTA; This spontaneous report was received from an office manager and referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-MAR-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection 25U/0.5 mL, 0.5 mL, lot #W006214, expiration date: 04-MAR-2023, administered for prophylaxis (route of administration and anatomical location were not provided) (expired product administered). No additional adverse event details were reported (no adverse event).
Sex: U
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: Postural Orthosthatic Tachycardia Syndrome; This spontaneous report was received from a consumer regarding a case in litigation, referring to a patient of unknown age and gender. Information about the patient medical history, concomitant medications, drug allergies or reactions was not provided.  On an unknown date,  the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), for prophylaxis (2 doses, scheme , dose, administration route, lot number and expiry date were not provided).  On an unknown date, after the two shots the patient experienced postural orthostatic tachycardia syndrome (POTS).    The outcome of postural orthostatic tachycardia syndrome was unknown.   The reporter considered postural orthostatic tachycardia syndrome to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL).  This is one o 2 cases from the same reporter.; Sender's Comments:  US-009507513-2303USA007746: US-009507513-2303USA007759:
Age: 25.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Viral titre decreased
Clinical narrative: HCP reported that a 25 year old patient received PROQUAD dose 4 weeks ago (exact date was unknown) because her titers were low. No additional AE reported. No PQC reported. No further information was provided.; HCP reported that a 25 year old patient received PROQUAD dose 4 weeks ago (exact date was unknown) because her titers were low. No additional AE reported. No PQC reported. No further information was provided.; This spontaneous report was received from Other Health Professional and refers to a 25-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date (also reported as 4 weeks ago), HCP reported that a 25 year old patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose, because her titers were low (Inappropriate age at vaccine administration). No additional AE reported. No PQC reported. No further information was provided. The action taken with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) regarding Antibody test negative was reported as Not Applicable.  The causal relationship between Antibody test negative and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.