chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: high temperature; chills; fever; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient experienced high temperature, chills and fever on an unspecified date. The patient underwent lab tests and procedures which included body temperature: high on an unspecified date. The outcome of the events was reported as unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; batch/lot# not reported), via an unspecified route of administration, on Mar 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unknown date (3 hours after the first dose), patient experienced itchiness; with outcome of unknown. No follow-up attempts possible. Information on lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Sinusitis
Clinical narrative: Fever 101.1; Chills; Body aches; Sinus infection; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 56-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via intramuscularly administered in Arm Left on 26Feb2021, 08:30 (Lot Number: EM9809, Expiry date: Unknown) as dose 2, single for COVID-19 immunisation, metoprolol (METOPROLOL), via an unspecified route of administration from an unspecified date (Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication, have been taking for a couple of years. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, Formulation: Solution for injection) via intramuscularly administered in Arm Left on 05Feb2021, 09:30 (Lot Number: EL9264, Expiry date: Unknown) as dose 1, single for COVID-19 immunisation and experienced red inflamed/very little redness when I got the vaccine/very red, itchy circle where vaccine was given, swelling on site, runny nose and stuffed nose. On 26Feb2021, the patient experienced fever 101.1, chills, body aches and sinus infection. The patient underwent lab tests and procedures which included body temperature: 101.1 and body temperature: 100.9. Therapeutic measures were not taken as a result of events fever, chills and body aches. Therapeutic measures were taken for the event sinus infections. The outcome of events fever, chills and body aches recovered on an unspecified date in 2021 and event sinus infection was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Nausea
Clinical narrative: Fatigue; Nausea; Joint pain; This is a spontaneous report from  a contactable consumer (patient). A 26-year-old non pregnant  female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route administration in the left arm on 28Feb2021 at 11:00 at the age of 26-years-old as a single dose for COVID-19 immunisation. Medical history included Crohn's disease and allergic to dairy and shellfish. The patient received unspecified medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. On an unspecified date in 2021, the patient experienced fatigue, nausea and joint pain. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcomes of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy on right side of face.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arteriogram coronary abnormal, Blood test abnormal, C-reactive protein increased, Chest X-ray abnormal, Chest pain
Clinical narrative: A 44-year-old man presented with chest pain and ST-segment elevation 4 days after receiving the second dose of mRNA-1273 SARS-CoV-2 Vaccine. Emergent coronary angiogram showed minimal coronary artery disease. Cardiac magnetic resonance imaging confirmed acute myocarditis. Diagnosis of vaccine-associated myocarditis was made given the temporal relationship and supportive treatment initiated. The patient was started on supportive therapy for his symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. He was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4?5?days after presentation. He was discharged home after 5?days of monitoring without evidence of electrical or haemodynamic instability and with NYHA Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. He remained asymptomatic and off diuretics.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coronary artery disease, Echocardiogram, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram ST segment elevation
Clinical narrative: A 44-year-old man presented with chest pain and ST-segment elevation 4 days after receiving the second dose of mRNA-1273 SARS-CoV-2 Vaccine. Emergent coronary angiogram showed minimal coronary artery disease. Cardiac magnetic resonance imaging confirmed acute myocarditis. Diagnosis of vaccine-associated myocarditis was made given the temporal relationship and supportive treatment initiated. The patient was started on supportive therapy for his symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. He was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4?5?days after presentation. He was discharged home after 5?days of monitoring without evidence of electrical or haemodynamic instability and with NYHA Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. He remained asymptomatic and off diuretics.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eosinophil count decreased, Left ventricular enlargement, Magnetic resonance imaging heart, Myocardial infarction, Myocardial oedema
Clinical narrative: A 44-year-old man presented with chest pain and ST-segment elevation 4 days after receiving the second dose of mRNA-1273 SARS-CoV-2 Vaccine. Emergent coronary angiogram showed minimal coronary artery disease. Cardiac magnetic resonance imaging confirmed acute myocarditis. Diagnosis of vaccine-associated myocarditis was made given the temporal relationship and supportive treatment initiated. The patient was started on supportive therapy for his symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. He was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4?5?days after presentation. He was discharged home after 5?days of monitoring without evidence of electrical or haemodynamic instability and with NYHA Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. He remained asymptomatic and off diuretics.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, N-terminal prohormone brain natriuretic peptide, N-terminal prohormone brain natriuretic peptide increased, Pulmonary oedema, Red blood cell sedimentation rate normal
Clinical narrative: A 44-year-old man presented with chest pain and ST-segment elevation 4 days after receiving the second dose of mRNA-1273 SARS-CoV-2 Vaccine. Emergent coronary angiogram showed minimal coronary artery disease. Cardiac magnetic resonance imaging confirmed acute myocarditis. Diagnosis of vaccine-associated myocarditis was made given the temporal relationship and supportive treatment initiated. The patient was started on supportive therapy for his symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. He was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4?5?days after presentation. He was discharged home after 5?days of monitoring without evidence of electrical or haemodynamic instability and with NYHA Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. He remained asymptomatic and off diuretics.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test negative, Systolic dysfunction, Troponin T increased, Ventricular hypokinesia
Clinical narrative: A 44-year-old man presented with chest pain and ST-segment elevation 4 days after receiving the second dose of mRNA-1273 SARS-CoV-2 Vaccine. Emergent coronary angiogram showed minimal coronary artery disease. Cardiac magnetic resonance imaging confirmed acute myocarditis. Diagnosis of vaccine-associated myocarditis was made given the temporal relationship and supportive treatment initiated. The patient was started on supportive therapy for his symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. He was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4?5?days after presentation. He was discharged home after 5?days of monitoring without evidence of electrical or haemodynamic instability and with NYHA Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. He remained asymptomatic and off diuretics.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count normal
Clinical narrative: A 44-year-old man presented with chest pain and ST-segment elevation 4 days after receiving the second dose of mRNA-1273 SARS-CoV-2 Vaccine. Emergent coronary angiogram showed minimal coronary artery disease. Cardiac magnetic resonance imaging confirmed acute myocarditis. Diagnosis of vaccine-associated myocarditis was made given the temporal relationship and supportive treatment initiated. The patient was started on supportive therapy for his symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. He was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4?5?days after presentation. He was discharged home after 5?days of monitoring without evidence of electrical or haemodynamic instability and with NYHA Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. He remained asymptomatic and off diuretics.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiocardiogram, Blood electrolytes, Blood magnesium, Brain natriuretic peptide, C-reactive protein
Clinical narrative: A 44-year-old man presented with chest pain and ST-segment elevation 4 days after receiving the second dose of mRNA-1273 SARS-CoV-2 Vaccine. Emergent coronary angiogram showed minimal coronary artery disease. Cardiac magnetic resonance imaging confirmed acute myocarditis. Diagnosis of vaccine-associated myocarditis was made given the temporal relationship and supportive treatment initiated. The patient was started on supportive therapy for his symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. He was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4?5?days after presentation. He was discharged home after 5?days of monitoring without evidence of electrical or haemodynamic instability and with NYHA Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. He remained asymptomatic and off diuretics.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac ventriculogram left, Catheterisation cardiac, Chest X-ray, Chest pain, Dyspnoea
Clinical narrative: A 44-year-old man presented with chest pain and ST-segment elevation 4 days after receiving the second dose of mRNA-1273 SARS-CoV-2 Vaccine. Emergent coronary angiogram showed minimal coronary artery disease. Cardiac magnetic resonance imaging confirmed acute myocarditis. Diagnosis of vaccine-associated myocarditis was made given the temporal relationship and supportive treatment initiated. The patient was started on supportive therapy for his symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. He was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4?5?days after presentation. He was discharged home after 5?days of monitoring without evidence of electrical or haemodynamic instability and with NYHA Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. He remained asymptomatic and off diuretics.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Full blood count, Intensive care
Clinical narrative: A 44-year-old man presented with chest pain and ST-segment elevation 4 days after receiving the second dose of mRNA-1273 SARS-CoV-2 Vaccine. Emergent coronary angiogram showed minimal coronary artery disease. Cardiac magnetic resonance imaging confirmed acute myocarditis. Diagnosis of vaccine-associated myocarditis was made given the temporal relationship and supportive treatment initiated. The patient was started on supportive therapy for his symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. He was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4?5?days after presentation. He was discharged home after 5?days of monitoring without evidence of electrical or haemodynamic instability and with NYHA Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. He remained asymptomatic and off diuretics.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Lipids, Liver function test, Magnetic resonance imaging heart, Metabolic function test
Clinical narrative: A 44-year-old man presented with chest pain and ST-segment elevation 4 days after receiving the second dose of mRNA-1273 SARS-CoV-2 Vaccine. Emergent coronary angiogram showed minimal coronary artery disease. Cardiac magnetic resonance imaging confirmed acute myocarditis. Diagnosis of vaccine-associated myocarditis was made given the temporal relationship and supportive treatment initiated. The patient was started on supportive therapy for his symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. He was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4?5?days after presentation. He was discharged home after 5?days of monitoring without evidence of electrical or haemodynamic instability and with NYHA Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. He remained asymptomatic and off diuretics.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Red blood cell sedimentation rate, Troponin T, Ultrasound scan
Clinical narrative: A 44-year-old man presented with chest pain and ST-segment elevation 4 days after receiving the second dose of mRNA-1273 SARS-CoV-2 Vaccine. Emergent coronary angiogram showed minimal coronary artery disease. Cardiac magnetic resonance imaging confirmed acute myocarditis. Diagnosis of vaccine-associated myocarditis was made given the temporal relationship and supportive treatment initiated. The patient was started on supportive therapy for his symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. He was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4?5?days after presentation. He was discharged home after 5?days of monitoring without evidence of electrical or haemodynamic instability and with NYHA Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. He remained asymptomatic and off diuretics.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage, Human chorionic gonadotropin, Ultrasound foetal abnormal
Clinical narrative: EDD: 01/27/2022 Miscarriage, 08/2021
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine dilation and curettage
Clinical narrative: EDD: 01/27/2022 Miscarriage, 08/2021
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: I had my 3rd Moderna  vaccination on Monday, October 27, 2021.  Tonight (9/30/21) around 8 pm I noticed a smooth red patch on my vaccinated arm.  It was not hot to the touch, it did not itch and it was not raised.  Now at 11:30 pm if appears to be "spreading/growing" in size.  It is be down from the vaccination site and is starting to circle the upper arm and has some "burning"......still not particularly warm to the touch, or raised.  It has not reached the inside of the arm.  At what may be the injection site (I can't see that part of my arm) is a raised "bump".  I did 1.5 hours of exercise with weights (working with a trainer).....so I have used the arm all day, without difficulty or pain.  On Tue/Wed after the shot, I did experience significant "chills" which I treated with  hot showers and Tylenol/Advil (alternating).
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoacusis, Nervousness, Sensation of blood flow, Unresponsive to stimuli
Clinical narrative: 18:10- patient vaccinated and at 18:14 patient states that he got a rush feeling to the head, hearing is going out, and shaky. At this time we laid out the yoga mat and transferred patient from chair to mat and immediately elevated his legs. Vital signs at 18:15 SP02 98%, HR 55, BP 100/62, diaphoretic. He couldn't respond for the first 20 seconds, but then said he felt much better and can see and hear fine again. Water bottle provided. At 18:20, vital signs: SP02 99%, HR 65, BP 114/60 RR 16. At this time he states he feels like he can sit on a chair, but we had him sit against the wall on the yoga mat. He stated he could use a snack and small bag of gold fish provided. He requested to sit on a chair, so we slowly stood him up and sat him on a chair. He said he felt "normal again" and we requested to stay an additional 15 minutes after to ensure he did not experience another adverse reaction. 18:30 Vital signs at 18:30, SP02 99%, HR 88, RR 18, BP 118/75. 18:35, patient requested to go home since he feels fine.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat, fatigue. This began 2 days after the injection; I woke up with the sore throat.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore arm, sore throat for 5 days, headaches ongoing
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Emotional disorder, Human chorionic gonadotropin negative, Injury, Ultrasound antenatal screen abnormal
Clinical narrative: Miscarriage, 08/2021
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine dilation and curettage
Clinical narrative: Miscarriage, 08/2021
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Blood test, Condition aggravated, Exposure to SARS-CoV-2, Heart rate increased
Clinical narrative: I can't say it is from the vaccine, but since getting the shot my resting heart rate has been high.  It was 120 resting when I first started checking on 10/8 when I was checking my pulse ox levels when I got sick with a cold since I didn't know if it was COVID.  The illness resolved within 3 days and got antibodies testing for COVID after the fact since after the fact I found out I had exposure to COVID prior to getting sick.  The COVID antibodies test showed no antibodies.     Anyway, about 10/10 my resting heart rate was 120 and walking around my house or up the stairs would raise my heart rate to 150.   I am now a month out and my resting heart rate is now down to 90-100.  My resting heart rate remained elevated until about 9/25 then it started to return to normal slowly.  It still goes up faster than normal.  As I said, I am not sure if it was the vaccine or the illness since I had not taken my pulse from 10/1 to 10/8 when I first starting getting sick with what felt like a mild cold.  But I do normally take my pulse, especially pre exercising and exercising and all the heart rates I have got during that time have never been in that range except for one time in 12/2020 that prompted an ER trip with a rapid pulse and constant vomiting (ultimately diagnosed as a virus- non covid).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Nasopharyngitis, SARS-CoV-2 antibody test negative, White blood cell count increased
Clinical narrative: I can't say it is from the vaccine, but since getting the shot my resting heart rate has been high.  It was 120 resting when I first started checking on 10/8 when I was checking my pulse ox levels when I got sick with a cold since I didn't know if it was COVID.  The illness resolved within 3 days and got antibodies testing for COVID after the fact since after the fact I found out I had exposure to COVID prior to getting sick.  The COVID antibodies test showed no antibodies.     Anyway, about 10/10 my resting heart rate was 120 and walking around my house or up the stairs would raise my heart rate to 150.   I am now a month out and my resting heart rate is now down to 90-100.  My resting heart rate remained elevated until about 9/25 then it started to return to normal slowly.  It still goes up faster than normal.  As I said, I am not sure if it was the vaccine or the illness since I had not taken my pulse from 10/1 to 10/8 when I first starting getting sick with what felt like a mild cold.  But I do normally take my pulse, especially pre exercising and exercising and all the heart rates I have got during that time have never been in that range except for one time in 12/2020 that prompted an ER trip with a rapid pulse and constant vomiting (ultimately diagnosed as a virus- non covid).
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen abnormal, Lipase increased, Pancreatitis acute
Clinical narrative: Patient admitted with pancreatitis 2 weeks after first covid vaccine. Discharged home after 2 day hospitalization for IV fluids and pain control.  ***VAERs report should have ALREADY been filed by family in August 2021. Filing additional report given that I am unable to verify if reported
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness on arm, slight itching
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Emotional distress, First trimester pregnancy, General physical condition abnormal, Pregnancy test negative
Clinical narrative: Miscarriage on 05/2021.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan abnormal
Clinical narrative: Miscarriage on 05/2021.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Medical Assistant accidentally gave patient a dose from a Janssen vial that was no longer viable. Vial was initially punctured on 9/29/21, and thus should not have been used today (date of service was 9/30/21). Medical director did call and speak with patient. Patient is aware that she was given a Janssen dose that was no longer viable. Patient denied adverse effects at time of this call between patient and medical director.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Two and a half weeks after the second shot  (around September 21st) I started getting red spots on my back and back of  thighs. The spots have spread and turned dark. They do not itch nor hurt as of yet. They are predominately on my upper back legs and all over my back. A few spots are now appearing under left breast stomach region.  I called a dermatologist and my primary care physician this week. My primary care physician told me over the phone I should go to the emergency room. Since I am not in pain,  I told them an emergency clinic would be a better option.   This evening around 5:00p.m  I visited a clinic and the physician explained to me that he?s seen such skin eruptions before as a result of the Covid vaccine  but never on dark skin as of yet.  He explained that the research is limited as of now as to why some have this reaction.   The timer is running out and I am not able to finish this report, but can explain more details if needed later.
Age: 55.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Developed moderate fever and whole body muscle sore as well as fatigue after about 10 hours of getting both the third (booster) dose of the Moderna Covid vaccine (left arm) and flu vaccine (right arm).  Also significant red swelling and pain at the injection site of Covid vaccine,  but the flu vaccine injection site has minimal redness/pain.  Took 2 aspirin around 12:30 mid night and fever continued (not getting worse ) about an hour after taking aspirin pills.
Age: 55.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pyrexia
Clinical narrative: Developed moderate fever and whole body muscle sore as well as fatigue after about 10 hours of getting both the third (booster) dose of the Moderna Covid vaccine (left arm) and flu vaccine (right arm).  Also significant red swelling and pain at the injection site of Covid vaccine,  but the flu vaccine injection site has minimal redness/pain.  Took 2 aspirin around 12:30 mid night and fever continued (not getting worse ) about an hour after taking aspirin pills.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Emotional distress, Human chorionic gonadotropin, Maternal exposure before pregnancy, Ultrasound foetal abnormal
Clinical narrative: Miscarriage / heavy bleeding, 07/2021  LMP, 08/12/2021
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Miscarriage / heavy bleeding, 07/2021  LMP, 08/12/2021
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Crying, Dyspnoea, Ear pain
Clinical narrative: While in the shower on Sunday - 2 days after-  I started coughing and could not catch my breath for the duration of about an hour. It was scary. Chest tight. Wheezing and coughing. Felt scared I couldn?t breathe.  It lessened in about an hour. I didn?t eat anything that night for fear of getting it stuck in my throat and scared of not breathing. I also started crying.   The next few days were of severe pain in my jaw and ears and head. The jaw and ear pain was extremely significant.  This lasted for 3 days. Kept me awake and ibuprofen did nothing. I also used ice packs. The pain was intense and throbbing for 3 straight days.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Headache, Insomnia, Pain, Pain in jaw
Clinical narrative: While in the shower on Sunday - 2 days after-  I started coughing and could not catch my breath for the duration of about an hour. It was scary. Chest tight. Wheezing and coughing. Felt scared I couldn?t breathe.  It lessened in about an hour. I didn?t eat anything that night for fear of getting it stuck in my throat and scared of not breathing. I also started crying.   The next few days were of severe pain in my jaw and ears and head. The jaw and ear pain was extremely significant.  This lasted for 3 days. Kept me awake and ibuprofen did nothing. I also used ice packs. The pain was intense and throbbing for 3 straight days.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: While in the shower on Sunday - 2 days after-  I started coughing and could not catch my breath for the duration of about an hour. It was scary. Chest tight. Wheezing and coughing. Felt scared I couldn?t breathe.  It lessened in about an hour. I didn?t eat anything that night for fear of getting it stuck in my throat and scared of not breathing. I also started crying.   The next few days were of severe pain in my jaw and ears and head. The jaw and ear pain was extremely significant.  This lasted for 3 days. Kept me awake and ibuprofen did nothing. I also used ice packs. The pain was intense and throbbing for 3 straight days.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia, Pain
Clinical narrative: Body aches and numbness, nerve pain and jolts.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis flair, pretty bad.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Hyperhidrosis, Pyrexia
Clinical narrative: After receiving the shot at noon, I began to feel shortness of breath and chest pain by evening, and by night time, I was experiencing fever. I was shivering and sweating at the same time in my bed that night. The following day (today) the shortness of breath and chest pain are still present, although less intense.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Headache, Joint stiffness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient (self) felt burning immediately as vaccine dose was being injected into muscle.  Arm became sore and stiff minutes later.  Stiffness and soreness seemed to spread to elbow moments later.  Stiffness in joints, shoulders and neck were experienced a few hours later.   Nausea and headache were experienced about 9-10hrs after injection.  Also, inside of right arm near wrist and left arm near elbow is itching.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus
Clinical narrative: Patient (self) felt burning immediately as vaccine dose was being injected into muscle.  Arm became sore and stiff minutes later.  Stiffness and soreness seemed to spread to elbow moments later.  Stiffness in joints, shoulders and neck were experienced a few hours later.   Nausea and headache were experienced about 9-10hrs after injection.  Also, inside of right arm near wrist and left arm near elbow is itching.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Hyperaesthesia, Injection site pain, Insomnia
Clinical narrative: Chills, fever of 101.2, body aches, skin sensitivity, inability to sleep,arm, where bad was given was very sore,  restlessness started the night received the third booster shot
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Restlessness
Clinical narrative: Chills, fever of 101.2, body aches, skin sensitivity, inability to sleep,arm, where bad was given was very sore,  restlessness started the night received the third booster shot
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nasal congestion, Nausea, Pain
Clinical narrative: Nausea, headache, weakness, stuffy nose, body aches
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Skin discolouration
Clinical narrative: EXTREME SWELLING OF BOTH ANKLES AND BOTH LEGS, PURPULISH PATCH NER TOES OR RIGHT LEG
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Heavy menstrual bleeding, Peripheral swelling, White blood cell count decreased
Clinical narrative: Started bleeding heavily bloody thick clots since day 1. I have been changing my tampon AND pad 2-3 times daily. I feel more fatigued and cannot exercise as well as I did before. More foggy sometimes blurry vision and edema and swelling in legs
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Rash on bilateral shins.  Started as 5 red spots, Progressed over 48 hours to form  one large area of redness to right distal knee/shin and one small area of redness on left ankle.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Eye irritation, Fatigue, Headache, Musculoskeletal pain
Clinical narrative: Became extremely tired a few hours after administration of the Jansen. At approximately 12am, 10/1, I was woken up w body aches, headache, stuffy nose, sore left arm & sore shoulder blade, burning eyes,  inability to sleep due to overall discomfort.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Became extremely tired a few hours after administration of the Jansen. At approximately 12am, 10/1, I was woken up w body aches, headache, stuffy nose, sore left arm & sore shoulder blade, burning eyes,  inability to sleep due to overall discomfort.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dyspnoea, Eye pain, Fatigue
Clinical narrative: Sudden onset right arm pain, runny nose, knot at injection site, body aches, fever, shortness of breath, wheezing , sore eyes / eye pain;  weakness, extreme fatigue , chest pain
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site nodule, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sudden onset right arm pain, runny nose, knot at injection site, body aches, fever, shortness of breath, wheezing , sore eyes / eye pain;  weakness, extreme fatigue , chest pain
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Wheezing
Clinical narrative: Sudden onset right arm pain, runny nose, knot at injection site, body aches, fever, shortness of breath, wheezing , sore eyes / eye pain;  weakness, extreme fatigue , chest pain
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus
Clinical narrative: Hands are itching SO BAD
Sex: U
Vaccine: VARZOS
Symptoms: Fear, Influenza like illness, Malaise, Oral mucosal blistering, Pain
Clinical narrative: blisters in my mouth; aches; flu like symptoms; This case was reported by a consumer via social media interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza-like symptoms, blistering of mouth and pain. On an unknown date, the outcome of the influenza-like symptoms, blistering of mouth and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, blistering of mouth and pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and was sick with flu like symptoms for 4 days, blisters in mouth and on the day 1 had aches. The above events were recovered. The patient was scared to get 2nd one. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Pain in extremity
Clinical narrative: sore arm; localized reaction, flared up three times; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received 1st dose on an unknown date, refer case US2021202241).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and local reaction. The patient was treated with ibuprofen, paracetamol (Acetaminophen) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the pain in arm and local reaction were recovered/resolved.   It was unknown if the reporter considered the pain in arm and local reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported the patient experienced sore arm and localized reaction after dose two of Shingrix vaccine. The health care professional reported that sore arm and localized reaction lasted for approximately one day but flared up three times within that day.  The patient treated the sore arm and localized reaction with ibuprofen, acetaminophen, and ice. The sore arm and localized reaction completely resolved.  The health care professional could not provide lot numbers or expiration dates of the dose given. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021202241:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: very sick from both vaccines; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (received 1st dose on an unknown date, refer case US2021AMR202716).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and felt very sick and it did not last long 24 hours and so far, the patient had no shingles. The patient stated that it had been a year since he/she got it. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202716:same reporter same patient
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (First case of shingles occurred on 29th April 2019).   On 13th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd September 2021, 953 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced second case of shingles. The second case of shingles was not yet resolved as it recently happened, but it was being treated. The patient did not get the second dose yet due to shortage of Shingrix in 2019 and pharmacy forgot to call her back. The reporter did not have lot number, expiry date, dosage of the first dose of Shingrix, and did not know if administered in left or right arm. The reporter gave a consent to follow-up with HCP. However, she does not have full mailing address, fax number, and email address to health care professional. The reporter consented to follow up. This case has been linked with case US2021AMR202745, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021202219:same reporter US-GLAXOSMITHKLINE-US2021AMR202745:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Only side effect was a sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date and experienced pain in arm, refer case US2021AMR202747) and original shingles vaccine (received it, few years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced pain in arm. The patient was treated with ibuprofen and non-drug therapy (Heating Pad (Nos)). Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received original shot a few years ago. The patient received dose of Shingrix vaccine and experienced sore arm. The patient stated that, the ibuprofen and a heating pad worked for the pain.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202747:Same patient, Dose no 1
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: shingle shots were awful; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a dose of Shingles vaccine and it was awful. Follow-up would not be possible as no contact details available. For tolerance of 2nd dose refer case US2021AMR202800.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202800:same patient same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Death, Product dispensing error, Recalled product administered
Clinical narrative: patient was diseased; a dose from the recalled batch was meant to be administrated; pharmacy dispensed a dose from the recall batch; This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 9lh3y, expiry date 7th February 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On 7th May 2021, unknown after receiving Shingrix, the patient experienced drug dispensing error. On an unknown date, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and recalled drug administered. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the recalled drug administered and drug dispensing error were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, their pharmacy dispensed on 7th May 2021 a dose of Shingrix from the recall batch. The vaccine was meant to be administrated to a female patient but the facility was unaware of the date of the administration.  The health care professional clarified that, the patient was diseased but did not clarify if there was a relationship between the death of the patient and the administration of the vaccine.  No further events were reported.  The Shingrix doses were administrated in another facility and the reporter did not know when (exact date) or if the vaccines were in fact administrated, they only have the date in which the vaccines were dispensed from the pharmacy which were after the date of the Shingrix recall.  The reporter did not know if the patients had adverse events after the administration of the vaccine. The health care professional agreed to be contacted for follow up. This is 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021202998:same reporter US-GLAXOSMITHKLINE-US2021203000:same reporter; Reported Cause(s) of Death: Unknown cause of death