chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19-2
Symptoms: White blood cell count increased
Clinical narrative: Bivalent COVID vaccine given on 9/27/22. 10/28/22 - 56-year-old female history of hypertension presents with flulike symptoms. Patient has had symptoms for 2 weeks (starting 10/14/22). Was seen at an urgent care and tested negative for COVID. Was treated supportively. Several days later was seen by primary care and treated with Mucinex and prednisone. Has continued to have cough myalgias fatigue and body aches. Has used over-the-counter medications with some relief. Denies any central chest pain but does note a left upper quadrant/left lower chest. With cough and shortness of breath. Cough is intermittently productive. She arrives EMS and was febrile in route. Is feeling faint and weak. She has not a smoker and has no cardiac history Patient presenting with fever palpitations and dyspnea. Concerning for myocarditis. No alternative source for infectious pathology given her elevated white blood cell count, fever, elevated CRP. Also with an elevated troponin and BNP with global ischemic changes on EKG that are also suggestive of cardiac pathology. Initially hypotensive and tachycardic which has improved with IV fluids. Her fever has resolved. Broadly cultured and provided IV antibiotic's to treat for empiric sepsis. No evidence of fulminant heart failure requiring vasopressors or respiratory support at this time. Cardiology consulted and will evaluate this morning for potential initiation of steroids for myocarditis. We will continue to treat supportively and monitor blood pressure and ensure no arrhythmias develop. Cardiology Note 10/29/22 PLAN/RECOMMENDATIONS: 1. Likely infective endocarditis of the aortic valve; 1 bottle thus far is positive for Streptococcus as transthoracic echo shows evidence of moderate size vegetation on the aortic valve 2. Acute kidney injury, resolved 3. Transient hypotension, resolved 4. Morbid obesity 5. Troponin elevation that have down trended with mild but flat elevation this a.m. Reviewed results with patient and overall plan of care and she understands that she is better served with transfer over to Medical Center for further evaluation to include further assessment with infectious disease service. Also potentially if patient requires CT surgery that is available. We will not perform transesophageal in our hospital as it will likely be performed at Medical Center. No further recommendations at this time
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Hiberix was not given with the diluent it comes with. Vaccines are not paired together with easy-to-read instructions.
Sex: M
Vaccine: FLUX
Symptoms: Acute left ventricular failure, Acute myocardial infarction, Anticoagulant therapy, Atrial fibrillation, Blood sodium decreased
Clinical narrative: Influenza vaccine given 10/8/2022. 70 y.o.male with past medical history of HTN, HLD who comes to the hospital urgently from the airport as he was in a trip. He was having sever SOB and cough and was gasping for air. He feels in distress and has some chest tightness. He does have orthopnea and pnds and feel that his lower extremity is becoming more swollen over the last few days. In the ED urgent echo with EF of 15%. He is in a fib with RVR. Amiodarone started. Patient BP is soft 90/60. Cardiology consulted
Sex: M
Vaccine: FLUX
Symptoms: Cardiac failure congestive, Cardiac stress test normal, Cardiogenic shock, Cardiomyopathy, Chest discomfort
Clinical narrative: Influenza vaccine given 10/8/2022. 70 y.o.male with past medical history of HTN, HLD who comes to the hospital urgently from the airport as he was in a trip. He was having sever SOB and cough and was gasping for air. He feels in distress and has some chest tightness. He does have orthopnea and pnds and feel that his lower extremity is becoming more swollen over the last few days. In the ED urgent echo with EF of 15%. He is in a fib with RVR. Amiodarone started. Patient BP is soft 90/60. Cardiology consulted
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Essential hypertension
Clinical narrative: Influenza vaccine given 10/8/2022. 70 y.o.male with past medical history of HTN, HLD who comes to the hospital urgently from the airport as he was in a trip. He was having sever SOB and cough and was gasping for air. He feels in distress and has some chest tightness. He does have orthopnea and pnds and feel that his lower extremity is becoming more swollen over the last few days. In the ED urgent echo with EF of 15%. He is in a fib with RVR. Amiodarone started. Patient BP is soft 90/60. Cardiology consulted
Sex: M
Vaccine: FLUX
Symptoms: Hyponatraemia, Hypotension, Peripheral swelling
Clinical narrative: Influenza vaccine given 10/8/2022. 70 y.o.male with past medical history of HTN, HLD who comes to the hospital urgently from the airport as he was in a trip. He was having sever SOB and cough and was gasping for air. He feels in distress and has some chest tightness. He does have orthopnea and pnds and feel that his lower extremity is becoming more swollen over the last few days. In the ED urgent echo with EF of 15%. He is in a fib with RVR. Amiodarone started. Patient BP is soft 90/60. Cardiology consulted
Sex: M
Vaccine: FLUA4
Symptoms: Abdominal pain upper, Back pain, Computerised tomogram abdomen abnormal, Dyspepsia, Fatigue
Clinical narrative: Influenza vaccination given on 10/21/2022. 70 year-old M with CAD s/p CABG x2, gallstones and Barrett's Esophagus presenting to ED after ~24 hours of burning epigastric pain with associated mid-back pain. Symptoms started on the morning of 10/26 while at work driving a school bus. He was able to complete work. He had a normal breakfast before symptom onset and reports his diet is fairly consistent. He didn't feel well when he returned home. He could eat and drink small amounts, but felt queasy. Anything he put in his stomach made the burning worse. He has not vomited. Pain continued on the day of admission and he felt generally exhausted. He went home and went to bed. Around 16:00, wife took his temperature and it was 100.4F. The pt preferred to wait it out but she convinced him to seek evaluation. In the ED, lipase was 250 and CT of the abdomen was c/w acute pancreatitis. He denies a history of the same. He doesn't drink alcohol and hasn't in 35 years. He doesn't smoke. He denies new medications.
Sex: M
Vaccine: FLUA4
Symptoms: Lipase increased, Malaise, Nausea, Pain, Pancreatitis acute
Clinical narrative: Influenza vaccination given on 10/21/2022. 70 year-old M with CAD s/p CABG x2, gallstones and Barrett's Esophagus presenting to ED after ~24 hours of burning epigastric pain with associated mid-back pain. Symptoms started on the morning of 10/26 while at work driving a school bus. He was able to complete work. He had a normal breakfast before symptom onset and reports his diet is fairly consistent. He didn't feel well when he returned home. He could eat and drink small amounts, but felt queasy. Anything he put in his stomach made the burning worse. He has not vomited. Pain continued on the day of admission and he felt generally exhausted. He went home and went to bed. Around 16:00, wife took his temperature and it was 100.4F. The pt preferred to wait it out but she convinced him to seek evaluation. In the ED, lipase was 250 and CT of the abdomen was c/w acute pancreatitis. He denies a history of the same. He doesn't drink alcohol and hasn't in 35 years. He doesn't smoke. He denies new medications.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Electrocardiogram abnormal, Extrasystoles, Heart rate decreased, Heart rate increased
Clinical narrative: Sun evening received pfizer covid vaccine booster for variants. Monday morning woke up with skipped heart beats pvcs and unsafe slow heart rate and chest pain. Pain worsened through out day. Condition did not improve. Sought ER treatment by evening and developed an unsafe high bpm rate and continued pvcs confirmed by Dr. Through ekg in er. Given a beta blocker toncorrect the issue. Pain worsened and spread through entire body and had to seek additional medical treatment. Treated with steroid to reduce inflammation. Severe chest pain and pain throughout my body. Worst pain ever felt.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inflammation, Pain, Ventricular extrasystoles
Clinical narrative: Sun evening received pfizer covid vaccine booster for variants. Monday morning woke up with skipped heart beats pvcs and unsafe slow heart rate and chest pain. Pain worsened through out day. Condition did not improve. Sought ER treatment by evening and developed an unsafe high bpm rate and continued pvcs confirmed by Dr. Through ekg in er. Given a beta blocker toncorrect the issue. Pain worsened and spread through entire body and had to seek additional medical treatment. Treated with steroid to reduce inflammation. Severe chest pain and pain throughout my body. Worst pain ever felt.
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Abdominal pain upper, Abstains from alcohol, Angiogram pulmonary abnormal, Arteriosclerosis coronary artery
Clinical narrative: Covid booster given 09/29/2022. On 10/01/2022, presents with acute pancreatitis. A pleasant 63-year-old female patient with past medical history of hypertension, obstructive sleep apnea on CPAP at night, GERD, history of asthma who presents patient was referred from Medical Center for acute pancreatitis. Patient reported epigastric abdominal pain that started around 1 PM today. She described her pain as dull aching and pressure-like with intensity of 10 out of 10 and radiating to the back. She reported associated nausea and vomiting of ingested matter. She denies fever or chills. She denies diarrhea. She denies chest pain or chest tightness. She denies urinary symptoms. She denies alcohol use. Vitals are stable. Her lab work from MC revealed WBC of 13.8, hemoglobin 14.1, platelet 247, creatinine 0.89, potassium 4.2, AST 164, ALT 151, alk phos 79, total bilirubin 0.7, lipase greater than 30,000, triglyceride 141. Initial troponin 0.7. CTA chest showed no PE. 8 mm nodule in the right middle lobe. CT abdomen/pelvis showed moderate peripancreatic inflammatory changes suggestive of acute pancreatitis. No pseudocyst or abscess collection. Hepatic steatosis. Minimal coronary calcification. RUQ US showed distended gallbladder with multiple stones. No peripancreatic fluid or gallbladder wall thickening. CBD measures 4 mm. GI consulted prior to transfer [no indication for ERCP/MRCP for now, surgical consultation in the morning recommended]. She has received normal saline bolus, Dilaudid, aspirin 324 mg prior to transfer.
Sex: F
Vaccine: COVID19-2
Symptoms: Aspartate aminotransferase increased, Back pain, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood creatinine normal
Clinical narrative: Covid booster given 09/29/2022. On 10/01/2022, presents with acute pancreatitis. A pleasant 63-year-old female patient with past medical history of hypertension, obstructive sleep apnea on CPAP at night, GERD, history of asthma who presents patient was referred from Medical Center for acute pancreatitis. Patient reported epigastric abdominal pain that started around 1 PM today. She described her pain as dull aching and pressure-like with intensity of 10 out of 10 and radiating to the back. She reported associated nausea and vomiting of ingested matter. She denies fever or chills. She denies diarrhea. She denies chest pain or chest tightness. She denies urinary symptoms. She denies alcohol use. Vitals are stable. Her lab work from MC revealed WBC of 13.8, hemoglobin 14.1, platelet 247, creatinine 0.89, potassium 4.2, AST 164, ALT 151, alk phos 79, total bilirubin 0.7, lipase greater than 30,000, triglyceride 141. Initial troponin 0.7. CTA chest showed no PE. 8 mm nodule in the right middle lobe. CT abdomen/pelvis showed moderate peripancreatic inflammatory changes suggestive of acute pancreatitis. No pseudocyst or abscess collection. Hepatic steatosis. Minimal coronary calcification. RUQ US showed distended gallbladder with multiple stones. No peripancreatic fluid or gallbladder wall thickening. CBD measures 4 mm. GI consulted prior to transfer [no indication for ERCP/MRCP for now, surgical consultation in the morning recommended]. She has received normal saline bolus, Dilaudid, aspirin 324 mg prior to transfer.
Sex: F
Vaccine: COVID19-2
Symptoms: Blood potassium normal, Blood triglycerides increased, Cholelithiasis, Computerised tomogram abdomen abnormal, Discomfort
Clinical narrative: Covid booster given 09/29/2022. On 10/01/2022, presents with acute pancreatitis. A pleasant 63-year-old female patient with past medical history of hypertension, obstructive sleep apnea on CPAP at night, GERD, history of asthma who presents patient was referred from Medical Center for acute pancreatitis. Patient reported epigastric abdominal pain that started around 1 PM today. She described her pain as dull aching and pressure-like with intensity of 10 out of 10 and radiating to the back. She reported associated nausea and vomiting of ingested matter. She denies fever or chills. She denies diarrhea. She denies chest pain or chest tightness. She denies urinary symptoms. She denies alcohol use. Vitals are stable. Her lab work from MC revealed WBC of 13.8, hemoglobin 14.1, platelet 247, creatinine 0.89, potassium 4.2, AST 164, ALT 151, alk phos 79, total bilirubin 0.7, lipase greater than 30,000, triglyceride 141. Initial troponin 0.7. CTA chest showed no PE. 8 mm nodule in the right middle lobe. CT abdomen/pelvis showed moderate peripancreatic inflammatory changes suggestive of acute pancreatitis. No pseudocyst or abscess collection. Hepatic steatosis. Minimal coronary calcification. RUQ US showed distended gallbladder with multiple stones. No peripancreatic fluid or gallbladder wall thickening. CBD measures 4 mm. GI consulted prior to transfer [no indication for ERCP/MRCP for now, surgical consultation in the morning recommended]. She has received normal saline bolus, Dilaudid, aspirin 324 mg prior to transfer.
Sex: F
Vaccine: COVID19-2
Symptoms: Gallbladder oedema, Haemoglobin normal, Hepatic steatosis, Laboratory test, Lipase increased
Clinical narrative: Covid booster given 09/29/2022. On 10/01/2022, presents with acute pancreatitis. A pleasant 63-year-old female patient with past medical history of hypertension, obstructive sleep apnea on CPAP at night, GERD, history of asthma who presents patient was referred from Medical Center for acute pancreatitis. Patient reported epigastric abdominal pain that started around 1 PM today. She described her pain as dull aching and pressure-like with intensity of 10 out of 10 and radiating to the back. She reported associated nausea and vomiting of ingested matter. She denies fever or chills. She denies diarrhea. She denies chest pain or chest tightness. She denies urinary symptoms. She denies alcohol use. Vitals are stable. Her lab work from MC revealed WBC of 13.8, hemoglobin 14.1, platelet 247, creatinine 0.89, potassium 4.2, AST 164, ALT 151, alk phos 79, total bilirubin 0.7, lipase greater than 30,000, triglyceride 141. Initial troponin 0.7. CTA chest showed no PE. 8 mm nodule in the right middle lobe. CT abdomen/pelvis showed moderate peripancreatic inflammatory changes suggestive of acute pancreatitis. No pseudocyst or abscess collection. Hepatic steatosis. Minimal coronary calcification. RUQ US showed distended gallbladder with multiple stones. No peripancreatic fluid or gallbladder wall thickening. CBD measures 4 mm. GI consulted prior to transfer [no indication for ERCP/MRCP for now, surgical consultation in the morning recommended]. She has received normal saline bolus, Dilaudid, aspirin 324 mg prior to transfer.
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Pain, Pancreatitis, Pancreatitis acute, Platelet count normal
Clinical narrative: Covid booster given 09/29/2022. On 10/01/2022, presents with acute pancreatitis. A pleasant 63-year-old female patient with past medical history of hypertension, obstructive sleep apnea on CPAP at night, GERD, history of asthma who presents patient was referred from Medical Center for acute pancreatitis. Patient reported epigastric abdominal pain that started around 1 PM today. She described her pain as dull aching and pressure-like with intensity of 10 out of 10 and radiating to the back. She reported associated nausea and vomiting of ingested matter. She denies fever or chills. She denies diarrhea. She denies chest pain or chest tightness. She denies urinary symptoms. She denies alcohol use. Vitals are stable. Her lab work from MC revealed WBC of 13.8, hemoglobin 14.1, platelet 247, creatinine 0.89, potassium 4.2, AST 164, ALT 151, alk phos 79, total bilirubin 0.7, lipase greater than 30,000, triglyceride 141. Initial troponin 0.7. CTA chest showed no PE. 8 mm nodule in the right middle lobe. CT abdomen/pelvis showed moderate peripancreatic inflammatory changes suggestive of acute pancreatitis. No pseudocyst or abscess collection. Hepatic steatosis. Minimal coronary calcification. RUQ US showed distended gallbladder with multiple stones. No peripancreatic fluid or gallbladder wall thickening. CBD measures 4 mm. GI consulted prior to transfer [no indication for ERCP/MRCP for now, surgical consultation in the morning recommended]. She has received normal saline bolus, Dilaudid, aspirin 324 mg prior to transfer.
Sex: F
Vaccine: COVID19-2
Symptoms: Pulmonary mass, Troponin, Ultrasound abdomen abnormal, Vomiting, White blood cell count increased
Clinical narrative: Covid booster given 09/29/2022. On 10/01/2022, presents with acute pancreatitis. A pleasant 63-year-old female patient with past medical history of hypertension, obstructive sleep apnea on CPAP at night, GERD, history of asthma who presents patient was referred from Medical Center for acute pancreatitis. Patient reported epigastric abdominal pain that started around 1 PM today. She described her pain as dull aching and pressure-like with intensity of 10 out of 10 and radiating to the back. She reported associated nausea and vomiting of ingested matter. She denies fever or chills. She denies diarrhea. She denies chest pain or chest tightness. She denies urinary symptoms. She denies alcohol use. Vitals are stable. Her lab work from MC revealed WBC of 13.8, hemoglobin 14.1, platelet 247, creatinine 0.89, potassium 4.2, AST 164, ALT 151, alk phos 79, total bilirubin 0.7, lipase greater than 30,000, triglyceride 141. Initial troponin 0.7. CTA chest showed no PE. 8 mm nodule in the right middle lobe. CT abdomen/pelvis showed moderate peripancreatic inflammatory changes suggestive of acute pancreatitis. No pseudocyst or abscess collection. Hepatic steatosis. Minimal coronary calcification. RUQ US showed distended gallbladder with multiple stones. No peripancreatic fluid or gallbladder wall thickening. CBD measures 4 mm. GI consulted prior to transfer [no indication for ERCP/MRCP for now, surgical consultation in the morning recommended]. She has received normal saline bolus, Dilaudid, aspirin 324 mg prior to transfer.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Pruritus, Swelling face
Clinical narrative: Starting coughing as mother and patient were leaving office. Mother called clinic reporting that patient had started itching, cough worsened and mom reported facial swelling.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: EUA Moderna Bivalent Covid 19, EUA
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: 10/27/2022 developed soft cough and low grade fever (99) late afternoon/evening 10/28/2022 tested positive at home for Covid 19 mild upper respiratory signs poor appetite, muscle aches, increasing fever peaked at 101.4.  began tylenol late afternoon. 10/29/2022 fever, headache responsive to tylenol q 8h. Received bebtelovimab IV infusion at home @ 3PM.  Flonase nasal spray used BID. 10/30/2022 continued OTC medications increased sneezing, little cough, less tired, some GI cramping and diarrhea 10/31/2022 no significant fever, took tylenol prn for muscle aches, minimal URI signs but ongoing diarrhea and poor appetite 11//2022 progressive diarrhea, poor appetite
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gastrointestinal pain, Headache, Myalgia, Pyrexia, Respiratory symptom
Clinical narrative: 10/27/2022 developed soft cough and low grade fever (99) late afternoon/evening 10/28/2022 tested positive at home for Covid 19 mild upper respiratory signs poor appetite, muscle aches, increasing fever peaked at 101.4.  began tylenol late afternoon. 10/29/2022 fever, headache responsive to tylenol q 8h. Received bebtelovimab IV infusion at home @ 3PM.  Flonase nasal spray used BID. 10/30/2022 continued OTC medications increased sneezing, little cough, less tired, some GI cramping and diarrhea 10/31/2022 no significant fever, took tylenol prn for muscle aches, minimal URI signs but ongoing diarrhea and poor appetite 11//2022 progressive diarrhea, poor appetite
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sneezing
Clinical narrative: 10/27/2022 developed soft cough and low grade fever (99) late afternoon/evening 10/28/2022 tested positive at home for Covid 19 mild upper respiratory signs poor appetite, muscle aches, increasing fever peaked at 101.4.  began tylenol late afternoon. 10/29/2022 fever, headache responsive to tylenol q 8h. Received bebtelovimab IV infusion at home @ 3PM.  Flonase nasal spray used BID. 10/30/2022 continued OTC medications increased sneezing, little cough, less tired, some GI cramping and diarrhea 10/31/2022 no significant fever, took tylenol prn for muscle aches, minimal URI signs but ongoing diarrhea and poor appetite 11//2022 progressive diarrhea, poor appetite
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Feeling hot, Fluid retention, Soft tissue swelling
Clinical narrative: Swelling, redness, heat Cellulitis - worsening / spreading over 4 days despite abx. (Keflex) Seen in ED changed to Clindamycin
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Swelling, Ultrasound scan abnormal
Clinical narrative: Swelling, redness, heat Cellulitis - worsening / spreading over 4 days despite abx. (Keflex) Seen in ED changed to Clindamycin
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: At the time of administration of vaccine the exp. date of 10/31/2022 was given to me on the LOT# FL2757. At a later date, 3wks. I was made aware that  the true exp date was shortened by the manufacturer and should actually have  been 9/30/22.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: At the time of administering vaccine the exp. date given to me was 10/31/22. On this LOT number. At a later date I was made aware that this LOT # had a shortened expiration by the manufacturer and was supposed to be 9/30/22.
Age: 77.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "MI" (unspecified if ongoing). Concomitant medication(s) included: APIXABAN, start date: 07May2022; CLOPIDOGREL, start date: 07May2022; ROSUVASTATIN, start date: 01Jan2020. Vaccination history included: Covid-19 vaccine (primary series completed with unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (dose 3, booster, unknown manufacturer), for COVID-19 immunisation. The following information was reported: COVID-19 (non-serious), outcome "not recovered", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Additional information: No known allergies. COVID 19 Treatment was Paxlovid which received from 15Oct2022 to 20Oct2022.
Age: 77.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "MI" (unspecified if ongoing). Concomitant medication(s) included: APIXABAN, start date: 07May2022; CLOPIDOGREL, start date: 07May2022; ROSUVASTATIN, start date: 01Jan2020. Vaccination history included: Covid-19 vaccine (primary series completed with unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (dose 3, booster, unknown manufacturer), for COVID-19 immunisation. The following information was reported: COVID-19 (non-serious), outcome "not recovered", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Additional information: No known allergies. COVID 19 Treatment was Paxlovid which received from 15Oct2022 to 20Oct2022.
Age: 77.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "MI" (unspecified if ongoing). Concomitant medication(s) included: APIXABAN, start date: 07May2022; CLOPIDOGREL, start date: 07May2022; ROSUVASTATIN, start date: 01Jan2020. Vaccination history included: Covid-19 vaccine (primary series completed with unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (dose 3, booster, unknown manufacturer), for COVID-19 immunisation. The following information was reported: COVID-19 (non-serious), outcome "not recovered", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Additional information: No known allergies. COVID 19 Treatment was Paxlovid which received from 15Oct2022 to 20Oct2022.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Alopecia universalis, Lymphadenopathy
Clinical narrative: Enlarged lymph nodes; Massive shedding of her scalp hair/he lost all of her body hair. One year later she has no regrowth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Aug2021 at 17:00 as dose 2, single (Lot number: Fc3181) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos's" (unspecified if ongoing); "Alopecia Areata", start date: 2018 (unspecified if ongoing), notes: She has a history of Alopecia Areata, with one episode in 2018; "ADD" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; METHYLPHENIDATE. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0198, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 07Jul2021, when the patient was 16-year-old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (disability) with onset 11Sep2021 at 08:00, outcome "not recovered", described as "Enlarged lymph nodes"; ALOPECIA AREATA (disability) with onset 11Sep2021 at 08:00, outcome "not recovered", described as "Massive shedding of her scalp hair/he lost all of her body hair. One year later she has no regrowth". The events "enlarged lymph nodes" and "massive shedding of her scalp hair/he lost all of her body hair. one year later she has no regrowth" required physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, alopecia areata.  Clinical course: On 23Aug 16 days after the second shot my daughter complained on enlarged lymph nodes that lasted unitl 09Sep. On 11Sep2021 she began with massive shedding of her scalp hair. Within 3 weeks she had lost all her hair on her scalp and was wearing a wig. Over the next month she lost all of her body hair. One year later she has no regrowth She has a history of Alopecia Areata, with one episode in 2018 with two small balding spots treated with cortizone ointment and resolved. Patient had treatment of high dose steroids, cortizone injections. No COVID prior vaccination. No COVID tested post vaccination.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia areata, Lymphadenopathy
Clinical narrative: Enlarged lymph nodes; Massive shedding of her scalp hair/he lost all of her body hair. One year later she has no regrowth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Aug2021 at 17:00 as dose 2, single (Lot number: Fc3181) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos's" (unspecified if ongoing); "Alopecia Areata", start date: 2018 (unspecified if ongoing), notes: She has a history of Alopecia Areata, with one episode in 2018; "ADD" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; METHYLPHENIDATE. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0198, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 07Jul2021, when the patient was 16-year-old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (disability) with onset 11Sep2021 at 08:00, outcome "not recovered", described as "Enlarged lymph nodes"; ALOPECIA AREATA (disability) with onset 11Sep2021 at 08:00, outcome "not recovered", described as "Massive shedding of her scalp hair/he lost all of her body hair. One year later she has no regrowth". The events "enlarged lymph nodes" and "massive shedding of her scalp hair/he lost all of her body hair. one year later she has no regrowth" required physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, alopecia areata.  Clinical course: On 23Aug 16 days after the second shot my daughter complained on enlarged lymph nodes that lasted unitl 09Sep. On 11Sep2021 she began with massive shedding of her scalp hair. Within 3 weeks she had lost all her hair on her scalp and was wearing a wig. Over the next month she lost all of her body hair. One year later she has no regrowth She has a history of Alopecia Areata, with one episode in 2018 with two small balding spots treated with cortizone ointment and resolved. Patient had treatment of high dose steroids, cortizone injections. No COVID prior vaccination. No COVID tested post vaccination.
Age: 60.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Anxiety, Expired product administered
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Oct2022 at 11:30 as dose number unknown (booster), single (Lot number: GH9693, Expiration Date: 30Jun2022) at the age of 60 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: coviD-19 vaccine (Dose 1:, Date: 16Dec2020, LOT: EJ1685), administration date: 16Dec2020, when the patient was 58-year-old, for COVID-19 immunization; coviD-19 vaccine (Dose 2:, Date: 05Jan2021, LOT: EL0142), administration date: 05Jan2021, when the patient was 58-year-old, for COVID-19 immunization; coviD-19 vaccine (Dose 3:, Date: 20Feb2022, LOT: FE3590), administration date: 20Feb2022, when the patient was 59-year-old, for COVID-19 immunization; Got her flu shot about a month ago (Got her flu shot about a month ago.). The following information was reported: HEADACHE (medically significant) with onset Oct2022, outcome "not recovered"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 29Oct2022, outcome "unknown", described as "Vaccine expired on 30Jun2022. Upset that she received an expired product". Therapeutic measures were not taken as a result of headache.  Clinical information: It was reported that the patient was upset that she received an expired product. Doesn't expect the vaccine to work as intended since it was expired. She knew some of the vaccines expiration dates were extended for 3 months, but not 4 months. There's a lot of vaccine hesitancy in communities, so the health department bought the vaccine out into the population and then the population was receiving an expired vaccine through the public health department. Concerned about the people who administered the vaccine because in previous doses, she was asked to sit and wait for 15 minutes after administration. Never had previous side effects, but that was protocol with previous administrations. She also witnessed the nursing student who was giving the vaccine put the cap back on the needle before disposing of it in the sharps container which was not best practice. Questioning the storage and the dilution because she knew it wasn't administered properly, so it makes her question these other things. Now, she had headache, but she doesn't knew if it had anything to do with the vaccine. She was more alert to these irregularities. did not required visit to emergency room or physician's office.
Age: 60.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Expired product administered, Headache
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Oct2022 at 11:30 as dose number unknown (booster), single (Lot number: GH9693, Expiration Date: 30Jun2022) at the age of 60 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: coviD-19 vaccine (Dose 1:, Date: 16Dec2020, LOT: EJ1685), administration date: 16Dec2020, when the patient was 58-year-old, for COVID-19 immunization; coviD-19 vaccine (Dose 2:, Date: 05Jan2021, LOT: EL0142), administration date: 05Jan2021, when the patient was 58-year-old, for COVID-19 immunization; coviD-19 vaccine (Dose 3:, Date: 20Feb2022, LOT: FE3590), administration date: 20Feb2022, when the patient was 59-year-old, for COVID-19 immunization; Got her flu shot about a month ago (Got her flu shot about a month ago.). The following information was reported: HEADACHE (medically significant) with onset Oct2022, outcome "not recovered"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 29Oct2022, outcome "unknown", described as "Vaccine expired on 30Jun2022. Upset that she received an expired product". Therapeutic measures were not taken as a result of headache.  Clinical information: It was reported that the patient was upset that she received an expired product. Doesn't expect the vaccine to work as intended since it was expired. She knew some of the vaccines expiration dates were extended for 3 months, but not 4 months. There's a lot of vaccine hesitancy in communities, so the health department bought the vaccine out into the population and then the population was receiving an expired vaccine through the public health department. Concerned about the people who administered the vaccine because in previous doses, she was asked to sit and wait for 15 minutes after administration. Never had previous side effects, but that was protocol with previous administrations. She also witnessed the nursing student who was giving the vaccine put the cap back on the needle before disposing of it in the sharps container which was not best practice. Questioning the storage and the dilution because she knew it wasn't administered properly, so it makes her question these other things. Now, she had headache, but she doesn't knew if it had anything to do with the vaccine. She was more alert to these irregularities. did not required visit to emergency room or physician's office.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Heplisav-B 1st Dose 2nd Dose Received was Engerix; Initial Report Received on 25-Aug-2022.  A pharmacist reported that a 42 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and the second dose received was Engerix  .  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 19-Jul-2022, the patient received the first dose of HEPLISAV-B (Lot # 937780, expiration date 14-Sep-2022 and NDC # 43528-003-05) in the left deltoid (route not provided).   On 19-Aug-2022, 31 days after having been vaccinated with HEPLISAV-B, the patient received Engerix. The patient reportedly experienced no adverse effects.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Second Dose with Engerix; Initial Report Received on 26-Aug-2022.  A pharmacist  reported that a 20 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient received the second dose with Engerix.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route and site not reported) at another pharmacy location. The information regarding the initial HEPLISAV-B dose was reported as unknown.  On 24-Aug-2022, an unspecified number of days after having been vaccinated with HEPLISAV-B, the patient received a dose with Engerix (Lot # 337TC, expiration date 29-Mar-2024, NDC# not provided).   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Wound drainage
Clinical narrative: Palpable 2.5 cm Nodule at Injection Site; Redness at Injection Site; Pain at Injection Site; Initial Report Received on 26-Aug-2022  A physician's assistant reported that a 27 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed redness, pain and a palpable 2.5 cm nodule at the injection site.  Medical history was reported as Crohn's disease, immunocompromised, and open sores on legs and body. Additionally, medical history reported the patient currently had a draining wound on leg. Allergies were reported as an unknown reaction to amoxicillin and penicillin.  Medications at the time of vaccination were reported as a "biologic for Crohn's".   On 19-Aug-2022, the patient received the first dose of HEPLISAV-B (Lot # 937780, expiration date 14-Sep-2023 and NDC # 43588-003 [partial]) in the right deltoid.  On an unspecified date, after having been vaccinated with HEPLISAV-B, and "two weeks" before the date of the report, the patient developed redness, pain, and a palpable 2.5 cm nodule at the injection site. The redness was reported as "gone" on the day of the report. The pain and the nodule were reported as ongoing.   A registered nurse also reported that the pain and redness were resolved, however the nodule was ongoing.   No additional information was reported.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Administered Dose of Heplisav-B to a 9 Month Old; Administered as Third Dose in the Series; Initial Report Received on 29-Aug-2022  An assistant nurse manager reported that a 9 month-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported. No known allergies were reported.  No relevant concomitant medications were reported.    On 29-Aug-2022, the 9 month-old patient received a dose of HEPLISAV-B (Lot # 935843, expiration date 08-Oct-2022 and NDC # 43528-003-05) in the right vastis lateralis (route not reported) from a registered nurse. It was reported that HEPLISAV-B "was administered a third dose in the series". No adverse events were reported.   No additional information was reported.   Company comment. The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation
Clinical narrative: SUSPECTED COVID-19 INFECTION (HEADACHE, COLD LIKE SYMPTOMS); REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via Pfizer concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 01 total, administered on left arm on 06-MAR-2021 09:00 for covid-19 prophylaxis. Age at time of vaccination 41 years old. Concomitant medications included Advil (ibuprofen) for drug used for unknown indication It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received additional dose of non-company suspect vaccine Moderna COVID-19 vaccine (elasomeran) (Dose number in series 2) (form of administration and route of administration were not reported, batch number: 012F21A CVS#1517 expiry: UNKNOWN) dose was not reported, administered on left arm on 22-OCT-2021 for covid-19 prophylaxis. On 22-OCT-2021, the patient revaccinated with different covid-19 vaccine (Dose number in series 2). The patient received additional dose of non-company suspect vaccine Pfizer (tozinameran) (Dose number in series 3) (form of admin and route of admin were not reported, batch number: GJ2524 GIANT 348 expiry: UNKNOWN) dose was not reported, administered on left arm on 15-SEP-2022 12:00 for covid-19 prophylaxis.  On OCT-2022, the patient experienced suspected covid-19 infection and she received covid-19 treatment of unspecified drug (form of administration and route of administration were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered from 07-OCT-2022 till 11-OCT-2022 for covid-19 treatment. 7 days after covid-19 treatment on 18-OCT-2022, symptoms again started with headache and cold like symptoms (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection (headache, cold like symptoms), and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: A 24-year-old female patient received BNT162b2 (BNT162B2), on 14Oct2022 at 14:55 as dose 1, 30 ug single (Lot number: FM7553, Expiration Date: Oct2022) at the age of 24 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing). There were no concomitant medications. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 14Oct2022 at 14:55, outcome "unknown" and all described as "The product stored when excursion occurred: Fridge (2 to 8 degree centigrade) Outside of fridge. Duration of Excursion: Days: 1, Hours: 1".    Follow-up attempts are completed. No further information is expected.  Follow-up (20Oct2022): This is a spontaneous follow-up report from the same contactable Pharmacist. This Pharmacist reported for a patient that: Updated information included: Reporter details added, Expiration date of suspect drug added, Vaccination facility name added, and events added.  Follow-up attempts are completed. No further information is expected.  Follow-Up (27Oct2022): Follow-up attempts are completed. No further information is expected.  Follow-up (01Nov2022): This is a spontaneous follow-up report received from a contactable Pharmacist in response to HCP letter sent. Updated information included: Reporter slider #02 added. Other medical history ongoing ticked. Vaccination time added. Anatomical location added. Vaccination facility details added. Onset time of previous events added.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: PNC20
Symptoms: Device malfunction
Clinical narrative: This complaint for caller only has the injection itself. Whoever gave the last one threw out the box. The only thing that she has is the broken vial for PREVNAR 20; The initial case was missing the following minimum criteria: Other-info not qualifying for AE reporting-Product complaint. Upon receipt of follow-up information on (27Oct2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2604) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious), outcome "unknown", described as "This complaint for caller only has the injection itself. Whoever gave the last one threw out the box. The only thing that she has is the broken vial for PREVNAR 20".  Additional information: Reportability Determination: This is Medical Device Related. Reportability Determination: This complaint for caller only has the injection itself. Whoever gave the last one threw out the box. The only thing that she has is the broken vial for PREVNAR 20V PFS SUSPENSION 0.5MLX10 is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury. Product used for treatment.