chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Melaena, Metabolic encephalopathy, Oesophagogastroduodenoscopy normal, Pneumonia, Respiratory failure
Clinical narrative: Clinical Summary Patient is a 76 y.o. male with a history of HFrEF, Atrial fibrillation, chronic left heel osteomyelitis  who presented to ER 11/27/22 with shortness of breath, transferred to alternate hospital 11/27/22 for ICU care. Course complicated by septic shock, (+)COVID, HAP with MDR-organism, and intubation. Medical Care assumed care 12/2/22 on transfer. Hospital course further complicated by progressive debility. Medical Care consulted 12/2/22 to assume care upon transfer.   1. Acute hypoxemic and hypercapnic respiratory failure: In the setting of COVID-19, HAP and left lung atelectasis. Chest x-ray 11/28/2022 with left hemothorax opacification. S/P bronchoscopy 11/28/2022. S/p inhaled thromboxane. Extubated 12/1/2022, weaned to 2-3L NC by 12/5/22.  2. COVID-19 Infection: Fully vaccinated, symptom onset 11/26/22, (+)test 11/27/22. Completed 10 days of Decadron end date 12/7/22 and out of isolation since 12/8/22. 3. HAP: BAL cultures 11/28/22 with MDR actinobacter. Completed Unasyn 12/6/22.  4. Septic shock: Likely related to above. Transiently required pressors in ER, resolved by 12/1/22. 5. Acute metabolic encephalopathy: Suspect metabolic from above. CT head 11/27/22 non-acute. Resolved. 6. Chronic left heel osteomyelitis: With diabetic neuropathy and PVD. Follows with Dr. (podiatry). Hospitalized at local facility on 10/2022 and placed on IV daptomycin and Invanz. Antibiotic course completed 11/28/22.  7. AKI on CKD3: Follows with Dr. (Nephrology) Baseline Cr 1.9, Cr 2.2  on admit due to septic shock. CR improved by 12/2/22 8. Persistent Hyperkalemia: due to AKI on CKD, added Lokelma 12/5/22.  9. CAD: S/p DES mid-LAD 5/2022. Continued asa, plavix and lipitor. 10. Chronic HFrEF: Ischemic CM, EF Nadir 35% (5/2022). Euvolemic on admit, last TTE 8/4/22 (at local facility) EF 50%. Initially held home Toprol XL due to hypotension, restarted 12/6/22. 11. Paroxysmal atrial fibrillation: AC stopped due to hx of recurrent GI bleeding in 11/2022 admit. Follows with Dr. who is considering LAA closure device in the future. Home BB and Propafenone restarted 12/6/22 12. Melena/recurrent GI bleed admitted 11/18 to 11/20/2022.  S/p blood transfusion.  EGD 11/19/2022 negative for bleeding. 13. Diet Controlled T2DM: Hgb A1c 5.9% on 5/13/22. Not on home medications. Stopped insulin 12/2/22. 14. Abnormal chest imaging: 3 cm right lower lobe calcified nodule on CT/5/16/2022.  Outpatient follow-up with repeat CT in 3 to 6 months. 15. Code status: DNR-CCA/DNI-Spouse. Palliative medicine following and has had multiple goals of care meetings.  16. DVT Prophylaxis: lovenox
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Septic shock, Transfusion
Clinical narrative: Clinical Summary Patient is a 76 y.o. male with a history of HFrEF, Atrial fibrillation, chronic left heel osteomyelitis  who presented to ER 11/27/22 with shortness of breath, transferred to alternate hospital 11/27/22 for ICU care. Course complicated by septic shock, (+)COVID, HAP with MDR-organism, and intubation. Medical Care assumed care 12/2/22 on transfer. Hospital course further complicated by progressive debility. Medical Care consulted 12/2/22 to assume care upon transfer.   1. Acute hypoxemic and hypercapnic respiratory failure: In the setting of COVID-19, HAP and left lung atelectasis. Chest x-ray 11/28/2022 with left hemothorax opacification. S/P bronchoscopy 11/28/2022. S/p inhaled thromboxane. Extubated 12/1/2022, weaned to 2-3L NC by 12/5/22.  2. COVID-19 Infection: Fully vaccinated, symptom onset 11/26/22, (+)test 11/27/22. Completed 10 days of Decadron end date 12/7/22 and out of isolation since 12/8/22. 3. HAP: BAL cultures 11/28/22 with MDR actinobacter. Completed Unasyn 12/6/22.  4. Septic shock: Likely related to above. Transiently required pressors in ER, resolved by 12/1/22. 5. Acute metabolic encephalopathy: Suspect metabolic from above. CT head 11/27/22 non-acute. Resolved. 6. Chronic left heel osteomyelitis: With diabetic neuropathy and PVD. Follows with Dr. (podiatry). Hospitalized at local facility on 10/2022 and placed on IV daptomycin and Invanz. Antibiotic course completed 11/28/22.  7. AKI on CKD3: Follows with Dr. (Nephrology) Baseline Cr 1.9, Cr 2.2  on admit due to septic shock. CR improved by 12/2/22 8. Persistent Hyperkalemia: due to AKI on CKD, added Lokelma 12/5/22.  9. CAD: S/p DES mid-LAD 5/2022. Continued asa, plavix and lipitor. 10. Chronic HFrEF: Ischemic CM, EF Nadir 35% (5/2022). Euvolemic on admit, last TTE 8/4/22 (at local facility) EF 50%. Initially held home Toprol XL due to hypotension, restarted 12/6/22. 11. Paroxysmal atrial fibrillation: AC stopped due to hx of recurrent GI bleeding in 11/2022 admit. Follows with Dr. who is considering LAA closure device in the future. Home BB and Propafenone restarted 12/6/22 12. Melena/recurrent GI bleed admitted 11/18 to 11/20/2022.  S/p blood transfusion.  EGD 11/19/2022 negative for bleeding. 13. Diet Controlled T2DM: Hgb A1c 5.9% on 5/13/22. Not on home medications. Stopped insulin 12/2/22. 14. Abnormal chest imaging: 3 cm right lower lobe calcified nodule on CT/5/16/2022.  Outpatient follow-up with repeat CT in 3 to 6 months. 15. Code status: DNR-CCA/DNI-Spouse. Palliative medicine following and has had multiple goals of care meetings.  16. DVT Prophylaxis: lovenox
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertent administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Angiogram pulmonary normal, COVID-19, Computerised tomogram thorax abnormal, Dyspnoea
Clinical narrative: Clinical Summary Patient is a 96 y.o. female with a history of HFpEF,  aortic valve disease, atrial fibrillation who was positive for COVID 12/8/22 presented to hospital 12/9/2022 with SOB. Found to be COVID positive, CTPA without PE noted.    1. COVID - 19 Infection: SOB started two days prior to admission with concern for hypoxia at SNF. Tested positive 12/8/22 for COVID infection at SNF and confirmed on admission. S/p Decadron and Remdesivir. Oxygen weaned off 2. Acute Hypoxic Respiratory Failure: requiring 2-4L NC on admission in the setting of above. CTPA on admission with no acute PE is identified. O2 weaned off 3. Chronic Atrial Fibrillation: per history. Follow with EP as outpatient. Per chart review significant AF burden of 24% noted 11/22/22 thus patient started on amiodarone and Eliquis at that time. BB adjusted 4. HFpEF: per history. TTE 6/22 with EF 55% with diastolic dysfunction noted. Continued home Lasix  5. Aortic Aneurysm: CTPA on admission with ascending thoracic aorta aneurysm measuring 4.1 cm and also the descending thoracic aorta measuring 3 cm remains stable. Recommended outpatient management and monitoring. 6. Pulmonary arterial hypertension: findings per CT on admit.  7. Urinary incontinence: chronic. Outpatient Urology evaluation 8. AS: per history s/p successful valve in valve TAVR 5/10/16 for critical aortic stenosis.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary arterial hypertension, SARS-CoV-2 test positive
Clinical narrative: Clinical Summary Patient is a 96 y.o. female with a history of HFpEF,  aortic valve disease, atrial fibrillation who was positive for COVID 12/8/22 presented to hospital 12/9/2022 with SOB. Found to be COVID positive, CTPA without PE noted.    1. COVID - 19 Infection: SOB started two days prior to admission with concern for hypoxia at SNF. Tested positive 12/8/22 for COVID infection at SNF and confirmed on admission. S/p Decadron and Remdesivir. Oxygen weaned off 2. Acute Hypoxic Respiratory Failure: requiring 2-4L NC on admission in the setting of above. CTPA on admission with no acute PE is identified. O2 weaned off 3. Chronic Atrial Fibrillation: per history. Follow with EP as outpatient. Per chart review significant AF burden of 24% noted 11/22/22 thus patient started on amiodarone and Eliquis at that time. BB adjusted 4. HFpEF: per history. TTE 6/22 with EF 55% with diastolic dysfunction noted. Continued home Lasix  5. Aortic Aneurysm: CTPA on admission with ascending thoracic aorta aneurysm measuring 4.1 cm and also the descending thoracic aorta measuring 3 cm remains stable. Recommended outpatient management and monitoring. 6. Pulmonary arterial hypertension: findings per CT on admit.  7. Urinary incontinence: chronic. Outpatient Urology evaluation 8. AS: per history s/p successful valve in valve TAVR 5/10/16 for critical aortic stenosis.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: No adverse event, Product administration error
Clinical narrative: THIS IS NO ADVERSE EVENT, NO SYMPTOMS TO REPORT, THIS IS JUST TO REPORT AN ADMINISTRATION ERROR
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Wrong product administered
Clinical narrative: Pt received MMR unintentionally.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 60 yo patient given High Dose Flu Vaccine which is indicated for 65 yo and up age group
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertent administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arterial injury, Asthenia, Chills, Deep vein thrombosis, Feeling of body temperature change
Clinical narrative: Approximately two hours after receiving vaccination, I began to have chills. I felt hot and cold and weakness, muscle spasms, and muscle pain. I had arm pain but not at the injection site. I did have bruising and hardness at the injection site. I had a rash and below my knees. A cream was applied and it went away. It took me about three days to recover. I went into day procedure venogram due to DVT which turned into an emergency surgery and an artery was nicked and I was bleeding so much I required a blood transfusion. I was discharged on December 24th, 2022.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Haemorrhage, Injection site bruising, Injection site induration, Muscle spasms, Myalgia
Clinical narrative: Approximately two hours after receiving vaccination, I began to have chills. I felt hot and cold and weakness, muscle spasms, and muscle pain. I had arm pain but not at the injection site. I did have bruising and hardness at the injection site. I had a rash and below my knees. A cream was applied and it went away. It took me about three days to recover. I went into day procedure venogram due to DVT which turned into an emergency surgery and an artery was nicked and I was bleeding so much I required a blood transfusion. I was discharged on December 24th, 2022.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity, Rash, Surgery, Transfusion, Venogram abnormal
Clinical narrative: Approximately two hours after receiving vaccination, I began to have chills. I felt hot and cold and weakness, muscle spasms, and muscle pain. I had arm pain but not at the injection site. I did have bruising and hardness at the injection site. I had a rash and below my knees. A cream was applied and it went away. It took me about three days to recover. I went into day procedure venogram due to DVT which turned into an emergency surgery and an artery was nicked and I was bleeding so much I required a blood transfusion. I was discharged on December 24th, 2022.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertent administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, SARS-CoV-2 test positive
Clinical narrative: Started having severe headaches with coughing. Tested positive for COVID-19 with a home test; Went to an urgent care and was prescribed PAXLOVID.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertent administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic dilatation, Cardiomyopathy, Computerised tomogram coronary artery abnormal, SARS-CoV-2 test negative
Clinical narrative: Several months after my 4th vaccine I experienced Cardiomyopathy. Increased calcium score. I went from basically with no problems at all with problems. The dramatic Aorta increased to 16 per tile. It was very low score now is off the chart. The diameter of my aorta increased. I went to the Cardiologist who did CT scan which revealed this information. I took several statin to help me with this issue.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Poor quality sleep
Clinical narrative: Left shoulder pain with decreased ROM starting evening s/p injection. Rated pain 6-10/10. Patient unable to sleep that evening.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertent administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertent administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Condition aggravated, Dyskinesia, Heart rate increased, Multiple sclerosis relapse
Clinical narrative: 8PM - body aches and chills  10:15pm to 11:30pm - uncontrollable body spasms/jerks. Heart rate increase and unable to talk normally. One word per spasm. Ended up having MS flare up from this reaction and still recovering from that.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle spasms, Pain, Speech disorder
Clinical narrative: 8PM - body aches and chills  10:15pm to 11:30pm - uncontrollable body spasms/jerks. Heart rate increase and unable to talk normally. One word per spasm. Ended up having MS flare up from this reaction and still recovering from that.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Influenza like illness, Nasal congestion
Clinical narrative: I had a sore throat, flu feeling, congestion in head and nose, and coughing because of tickling in my throat. I tested positive for COVID-19 at home. I talked to my doctor and was prescribed PAXLOVID. 7 days after taking PAXLOVID I started having the same symptoms but milder. I tested myself again for COVID-19 but I never tested positive again. I still am having mild sore throat, fatigue, and sneezing.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I had a sore throat, flu feeling, congestion in head and nose, and coughing because of tickling in my throat. I tested positive for COVID-19 at home. I talked to my doctor and was prescribed PAXLOVID. 7 days after taking PAXLOVID I started having the same symptoms but milder. I tested myself again for COVID-19 but I never tested positive again. I still am having mild sore throat, fatigue, and sneezing.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat irritation
Clinical narrative: I had a sore throat, flu feeling, congestion in head and nose, and coughing because of tickling in my throat. I tested positive for COVID-19 at home. I talked to my doctor and was prescribed PAXLOVID. 7 days after taking PAXLOVID I started having the same symptoms but milder. I tested myself again for COVID-19 but I never tested positive again. I still am having mild sore throat, fatigue, and sneezing.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertent administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Chills, Pain
Clinical narrative: 9pm stomaxh cramping, chills, body ache
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Feeling abnormal, Oropharyngeal pain, Pyrexia
Clinical narrative: 11/21/2022 Nasal Sore throat and fever peaking at 101.9 and chills.  Tested with an At HOME COVID-19 test, Positive.  11/22 televisit with doctor.  Doctor advised of isolation and treating symptomatically.  Symptoms were consistent for about 6 days and then stopped suddenly.  Experienced Brain Fog for about 2 weeks after that.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinalgia, SARS-CoV-2 test positive
Clinical narrative: 11/21/2022 Nasal Sore throat and fever peaking at 101.9 and chills.  Tested with an At HOME COVID-19 test, Positive.  11/22 televisit with doctor.  Doctor advised of isolation and treating symptomatically.  Symptoms were consistent for about 6 days and then stopped suddenly.  Experienced Brain Fog for about 2 weeks after that.
Age: 58.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pruritus
Clinical narrative: Itching on hands spread to ears and scalp. I told her to go to urgent care as it was increasing in severity during our call
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Pruritus, Urticaria
Clinical narrative: She got hives all over her back and legs. She was very itchy and uncomfortable. We gave her an allergy pill and put hydrocortisone cream on the affected areas. The hives had cleared by morning.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertent administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
Age: 81.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: After the two vaccinations, patient got home and she fainted and hit her head and that there was blood bleeding  from her head. She said there seems to be a lump on her head.  Patient had no previous history of dizziness or fainting.  Patient was recommended to go to the ER.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Ear neoplasm, Hyperacusis
Clinical narrative: I noticed a hearing distortion within the hour after taking the Booster Shot.  The distortion has worsened over the past year.  The distortion is a loudness of the outside sounds that becomes distorted.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaemia, Biopsy endometrium, Blood iron, Blood test, Fatigue
Clinical narrative: Had heavier than normal periods, sometimes bleeding through a pad within an hour for several hours a day for the 2 heavy days of my period.  Anemia soon developed.  Was first diagnosed with anemia in August 2021 - received infusions.  Had the booster shot in Fed 2022; was anemic again by May 2022 - Ferritin level was down to a 4 each time, very fatigued and symptomatic.  Received infusions.  Anemic again by Nov 2022 - needed to receive infusions again.  Seems to be getting a little better, down to 1 to 1-1/2 heavy bleeding days.  Still going though a #4 Always Brand thin overnight pad in a hour for a couple hours in a row on a heavy flow day.  I will not be getting any more Covid vaccines just to see if enables improvement.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Heavy menstrual bleeding, Infusion, Iron binding capacity total, Serum ferritin decreased
Clinical narrative: Had heavier than normal periods, sometimes bleeding through a pad within an hour for several hours a day for the 2 heavy days of my period.  Anemia soon developed.  Was first diagnosed with anemia in August 2021 - received infusions.  Had the booster shot in Fed 2022; was anemic again by May 2022 - Ferritin level was down to a 4 each time, very fatigued and symptomatic.  Received infusions.  Anemic again by Nov 2022 - needed to receive infusions again.  Seems to be getting a little better, down to 1 to 1-1/2 heavy bleeding days.  Still going though a #4 Always Brand thin overnight pad in a hour for a couple hours in a row on a heavy flow day.  I will not be getting any more Covid vaccines just to see if enables improvement.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound uterus
Clinical narrative: Had heavier than normal periods, sometimes bleeding through a pad within an hour for several hours a day for the 2 heavy days of my period.  Anemia soon developed.  Was first diagnosed with anemia in August 2021 - received infusions.  Had the booster shot in Fed 2022; was anemic again by May 2022 - Ferritin level was down to a 4 each time, very fatigued and symptomatic.  Received infusions.  Anemic again by Nov 2022 - needed to receive infusions again.  Seems to be getting a little better, down to 1 to 1-1/2 heavy bleeding days.  Still going though a #4 Always Brand thin overnight pad in a hour for a couple hours in a row on a heavy flow day.  I will not be getting any more Covid vaccines just to see if enables improvement.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Nasal congestion, Oropharyngeal pain, Pain, Pruritus
Clinical narrative: 11/24/2022 in the middle of the night I started to have a scratchy throat, itching, and sneezing. I decided to take a home COVID-19 test that did come out positive. I developed a severe sore throat, body aches, sneezing and a low grade fever. Nasal congestion, low grade fever and dripping nose for a few days. Sore throat was lasting for about 4 days that was extremely painful. I tried to take lozenges and TYLENOL however it did not improve. It started to improve by the 5th day. I began taking the PAXLOVID from Nov 24th night until completion. I am now doing fine and feeling completely normal. I did have a rebound of symptoms after 2 days post my last PAXLOVID dose.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing, Throat irritation
Clinical narrative: 11/24/2022 in the middle of the night I started to have a scratchy throat, itching, and sneezing. I decided to take a home COVID-19 test that did come out positive. I developed a severe sore throat, body aches, sneezing and a low grade fever. Nasal congestion, low grade fever and dripping nose for a few days. Sore throat was lasting for about 4 days that was extremely painful. I tried to take lozenges and TYLENOL however it did not improve. It started to improve by the 5th day. I began taking the PAXLOVID from Nov 24th night until completion. I am now doing fine and feeling completely normal. I did have a rebound of symptoms after 2 days post my last PAXLOVID dose.
Sex: F
Vaccine: RV5
Symptoms: Extra dose administered, Vomiting
Clinical narrative: patient vomited up a first dose of ROTATEQ then was administered another.; patient vomited up a first dose of ROTATEQ then was administered another.; patient vomited up a first dose of ROTATEQ then was administered another.; This spontaneous report was received from Other Health Professional and refers to a 4-month-old female. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 22-NOV-2022, the was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid at a dose of 2ml orally (vaccination scheme frequency was not provided; valid lot number U026661 with expiration date of 22-JAN-2022). The patient vomited up the first dose of the vaccine (vomiting of medication, accidental underdose); therefore, she was administered another dose rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid at a dose of 2ml orally (valid lot number U026661 with expiration date of 22-JAN-2022) (extra dose administered). Both doses were administered as prophylaxis.  The outcome of the event of vomiting of medication and the causal relationship between the event and the suspect therapy were not reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: is now 8 years old and has not receive the second dose of MMR II and VARIVAX as recommended; No additional AE reported.; This spontaneous report was received from a nurse and refers to an 8-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 ml; and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, both administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) as per prescribing information. However, the patient was currently 8 years old, and had not received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) as recommended. No additional adverse events were reported.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Strabismus
Clinical narrative: developed Esotropia 7 days after receiving the vaccine; This spontaneous report was received from a physician and refers to a 5-year-old male patient. The patient's medical history, concomitant therapies, and concurrent conditions were not provided.   On an unknown date in March 2022, the patient was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered subcutaneously (dose, dose number, strength, site of administration, lot #, and expiration date were not provided) for prevention of measles, mumps, rubella and varicella.   On an unknown date in 2022 [reported as "7 days after receiving the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)"], the patient developed esotropia. The patient still had esotropia 6 months after measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The patient was being seen by an eye specialist, and there was no surgery at that time. The patient was wearing glasses to try and correct it.  The relatedness between the suspect therapy and the event was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller reporting VARIVAX was administered after a temperature excursion that occurred on 10/13/2022. This excursion was supported.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 13-OCT-2022, the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) underwent temperature excursions of -12.04 degree Celsius (C) for time frame 45 minutes, no previous temperature excursion was reported. On 30-NOV-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U015847, expiration date: 19-MAY-2023, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA004483:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE. No side effects were noted.; HCP reported ROTATEQ was possibly administered after a temperature excursion. Dates of administration and patient demographics were unknown as caller was unsure if an administration occurred. Caller did not have any further clarifying details. No add; This non-valid spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On an unspecified date, the patients were vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided;  valid lot number W020326 with expiration date 17-OCT-2023). The administered dose of the vaccine experienced a temperature excursion 48 degrees Fahrenheit for 15 minutes. If a data logger was implied, it was not mentioned. There was no previous temperature excursion or adverse effect reported.  This case was considered non-valid due to the lack of patients identifiers.  Follow up information has been received from the medical assistant on 19-DEC-2022. This spontaneous report was regarding a 3-months-old male patient (2 months old according to patient's date of birth and administration of the dose, conflicting information). On 23-NOV-2022, the patient was administered improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTAVIRUS) oral liquid orally as prophylaxis (previously mentioned) (strength, dose and scheme were not reported). The vaccine was administered by a trained Health care professional and was reported to be used according to the instruction leaflet. Additionally it was stated the temperature excursion did not occurred as a result of the reading from a Data Logger.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX was administered after a temperature excursion that occurred on 10/13/2022.; This spontaneous report was received from a nurse referring 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 13-OCT-2022, the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) underwent temperature excursions of minus 12.04 degree Celsius (C) for time frame 45 minutes. On 03-NOV-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U015847, expiration date: 19-MAY-2023, for prophylaxis (strength, and route of administration were not provided) (product storage error). There were no previous temperature excursions.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA004096:
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is a 2 year old male who was given a single adult dose of VAQTA.; This spontaneous report has been received from a laboratory medical technician, referring a 2-year-old male patient. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 16-DEC-2022, the patient was vaccinated with a single adult dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection 0.5 milliliter (lot number W008110 has been verified to be a valid lot number, expiry date 27-OCT-2023) indicated as prophylaxis (strength was not reported) (product administered to patient of inappropriate age).
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion; No additional AEs; This spontaneous report was received from a registered nurse and refers to a 14-year-old female. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 05-DEC-2022, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #U036586, expiration date: 21-OCT-2023, administered intramuscularly for prophylaxis (strength, exact dose and dose number was not provided) and influenza vaccine live reassort 3v (FLUMIST), lot #PH3533B, expiration date: 21-OCT-2023, administered nasally for prophylaxis (strength, exact dose, dose number, and formulation were not provided) (Product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. No adverse events were reported (No adverse event).  The reporter considered temperature excursion to be not related to suspect vaccines.
Sex: F
Vaccine: BCG
Symptoms: Disseminated Bacillus Calmette-Guerin infection
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated above, and refers to a 6-months-old female patient. The patient was homozygous for a newly identified large deletion that removed the last six exons of TYK2. She also had generalized HSV infection and allergic dermatitis (also reported as atopy).   On an unknown date, the patient was vaccinated with bcg live (BCG LIVE) (strength, dose, lot #, expiration date and route of administration were not provided) for tuberculosis bladder.  On an unknown date, also reported as at the age of 6-mo-old, the patient developed BCG-itis following bcg live (BCG LIVE) vaccination. On an unknown date, reported as at the age of 1 year old, the patient presented disseminated BCG-osis( submandibular, cervical,and axillary). She was treated with anti-tuberculosis (TB) drugs. The outcome of the events was unknown.   The reporter considered both events to be related to bcg live (BCG LIVE). Upon internal review, the events of BCG-itis and disseminated BCG disease were determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports derived from the same literature article. ; Sender's Comments:  US-009507513-2212USA006304:
Sex: U
Vaccine: COVID19
Symptoms: Death, Fall, Guillain-Barre syndrome, Laboratory test
Clinical narrative: GUILLAIN-BARRE SYNDROME; GOT OUT OF BED ONE NIGHT AND HIT THE FLOOR; DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. 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, about two weeks later, the patient got out of bed one night and hit the floor, patient's legs were paralyzed, underwent many tests and was diagnosed with Guillain-barre syndrome and was hospitalized (date unspecified). The number of days of hospitalization was not reported. Patient had nightmare and was bedridden. On an unspecified date, the patient died from an unknown cause of death. It was unknown if an autopsy was performed or not. Reporter stated that, "Same thing happened to someone I worked with." It was reported "My very best friend in the world could not wait to get the covid vaccine back in 2020. She had to wait until her age group was available, she was 63. She was finally okayed. About two weeks later she got out of bed one night and hit the floor. Her legs were paralyzed. After finally going to a few doctors she was hospitalized. Many tests later she was diagnosed with Gillian Barre' Syndrome. After living a nine month nightmare she passed away. J.and J.was contacted but nothing was done. A perfectly healthy woman went to a bedridden person who was sick everyday for the remainder of her life. So,so sad." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre syndrome and got out of bed one night and hit the floor was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20221237321.; Sender's Comments: V0: 20221245268- Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable. 20221245268- Guillan-Barre syndrome. The event has a unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration. 20221245268- Got out of bed one night and hit  the floor- The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: CLOSE TO DEATH AND WOULD UNDERGO 4 HEAVY OPERATIONS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced close to death and would undergo 4 heavy operations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of close to death and would undergo 4 heavy operations was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Cardiac disorder
Clinical narrative: HEART PROBLEMS; ALMOST DIED; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (2 patients) of unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. The patient's pre-existing medical conditions included: The patients had no health conditions or problems at all before the vaccine and never had covid. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy dates 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 patients wound up in the hospital and one of them almost died (adverse event not specified) and they both had heart problems and were under the care of a heart specialist (had physician office visit). The number of days of hospitalization was not reported. As per reporter, "One small example was two people in our family never had covid but went and got the covid shots and wound up in the hospital and one of them almost died now they both have heart problems and are under the care of a heart specialist now probably for the rest of their lives neither one of them had any health conditions or problems at all before the vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart problems and almost died was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20221251578-Heart problem. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20221251578- Almost died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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 got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000264421.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Ageusia, Bedridden, Feeding disorder, Head discomfort, Pain
Clinical narrative: CONSTANT BODY PAIN; CEMENT HEAD; NO TASTE; UNABLE TO EAT MORE THAN A COUPLE OF MOUTHFULLS OF FOOD OR DRINK THE USUAL 2-3 QUARTS OF WATER DAILY; LOST 6 POUNDS IN ONE MONTH; DID NOT GET OUT OF BED OR GET DRESSED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. 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 05-OCT-2022 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect vaccine included: influenza vaccine (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 05-OCT-2022 for prophylactic vaccination. No concomitant medications were reported.  On 2022, the patient experienced constant body pain, cement head, no taste, unable to eat more than a couple of mouthfulls of food or drink the usual 2-3 quarts of water daily, lost 6 pounds in one month, and did not get out of bed or get dressed. The action taken with covid-19 vaccine ad26.cov2.s, and influenza vaccine was not applicable. The patient was recovering from constant body pain, no taste, unable to eat more than a couple of mouthfulls of food or drink the usual 2-3 quarts of water daily, lost 6 pounds in one month, did not get out of bed or get dressed, and cement head. This report was non-serious.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Weight decreased
Clinical narrative: CONSTANT BODY PAIN; CEMENT HEAD; NO TASTE; UNABLE TO EAT MORE THAN A COUPLE OF MOUTHFULLS OF FOOD OR DRINK THE USUAL 2-3 QUARTS OF WATER DAILY; LOST 6 POUNDS IN ONE MONTH; DID NOT GET OUT OF BED OR GET DRESSED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. 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 05-OCT-2022 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect vaccine included: influenza vaccine (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 05-OCT-2022 for prophylactic vaccination. No concomitant medications were reported.  On 2022, the patient experienced constant body pain, cement head, no taste, unable to eat more than a couple of mouthfulls of food or drink the usual 2-3 quarts of water daily, lost 6 pounds in one month, and did not get out of bed or get dressed. The action taken with covid-19 vaccine ad26.cov2.s, and influenza vaccine was not applicable. The patient was recovering from constant body pain, no taste, unable to eat more than a couple of mouthfulls of food or drink the usual 2-3 quarts of water daily, lost 6 pounds in one month, did not get out of bed or get dressed, and cement head. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: DIED; BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned multiple (unspecified number) patients of an unspecified age, sex, race and ethnicity The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) 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 patients experienced blood clots and died. It was unspecified if an autopsy was performed. It was reported as "This vaccine was an experimental drug. I didn't take it but people I know did. That's why they ended up with blood clots and died. Do take any of these vaccines". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patients died from unknown cause of death and the outcome of blood clots was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20221252693-Died, Blood clot. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID MULTIPLE TIMES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19prophylaxis. 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 covid multiple times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid multiple times was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000264468. This case, from the same reporter is linked to 20221255553.
Sex: U
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS; This spontaneous report received from a patient via a social media through company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, and expiry: Unknown) dose, start therapy date were not reported, 1 total, dose 1 (first shot) 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 following vaccination with first shot of covid-19 vaccine ad26.cov2.s, the patient experienced rheumatoid arthritis. It was reported as "1st shot put me into rheumatoid arthritis and I've been in a living hell and I reported and it did t do anything you dont give a care about any of us and our side effects". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rheumatoid arthritis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221252714-rheumatoid arthritis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.