chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, HPV9
Symptoms: Anti-thyroid antibody, Antinuclear antibody positive, Autoimmune thyroiditis, Raynaud's phenomenon, Total complement activity test
Clinical narrative: Hashimoto thyroiditis; Raynaud's phenomenon; This report was identified by the Food & Drug Administration (VAERS ID 858273) on 04-FEB-2022.   This spontaneous report was received from a nurse referring to an approximately 13-year-old female patient. The patient's concomitant therapies, and chronic or long-standing health conditions were not provided. She had no allergies to medications, food, or other products. Moreover, she had no other illnesses at the time of vaccination and up to one month prior.  On 19-NOV-2018 at 14:45, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscularly (IM) in the left thigh (strength, frequency, and dose were not reported) for prophylaxis. Reported lot number R003557 was not valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). However, lot number R003557 is valid for HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). At the same time, she was also vaccinated with the first dose of influenza vaccine live reassort 3v (FLUMIST), nasal administration for prophylaxis (strength, frequency, dose and expiration date were not reported; lot number was reported as K12237).  On 01-JAN-2019, the patient experienced Raynaud's phenomenon, which was diagnosed on 21-JAN-2019. On 21-JAN-2019, the patient underwent the following laboratory tests: thyroid peroxidase antibodies (ab) 419 (units not provided) and antinuclear antibody 1:160, which resulted positive. On 31-JAN-2019, the patient was diagnosed with Hashimoto's thyroiditis (autoimmune thyroiditis). On an unspecified date in 2019, the patient underwent a CH50 test which resulted greater than 60 (unit not reported). At the time of reporting, the patient had not recovered from the events.  The causal relationship between the vaccines, Raynaud's phenomenon and autoimmune thyroiditis was unknown.   As of 14-FEB-2022, all telephone attempts trying to obtain additional information has been unsuccessful.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest X-ray, Computerised tomogram, Confusional state, Dizziness
Clinical narrative: Dizziness, tightness in my throat, my voice changed. Brain fog, joint pain, muscle pains. Confusion, shortness of breath, fatigue. Everything was moving at a very slow motion, like I was being sedated,
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dyspnoea, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: Dizziness, tightness in my throat, my voice changed. Brain fog, joint pain, muscle pains. Confusion, shortness of breath, fatigue. Everything was moving at a very slow motion, like I was being sedated,
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Dizziness, tightness in my throat, my voice changed. Brain fog, joint pain, muscle pains. Confusion, shortness of breath, fatigue. Everything was moving at a very slow motion, like I was being sedated,
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test normal, Borrelia test negative, Computerised tomogram normal, Coordination abnormal
Clinical narrative: Several hours after receiving vaccine I noticed swelling on the right side of my neck. By the time I got home from lunch there was a half of a golf ball size lump on the side of my neck.  I was having difficulty swallowing. My right ear began to hurt.  I had another area swollen under my jaw line by 9pm.  I was very light headed.  That night I was cleaning and bent over--I felt like I was hit on my head and my head was tingling and I developed immense pain. I can't remember how long I was laying on the bed.  I finally went to sleep around midnight and when I woke up the lump on my neck was larger, the right side of my face was paralyzed and I had a painful migraine.   I did two virtual visits with Clinic.  They instructed me to go to the emergency room.  At the er they diagnosed me with bells palsy, the doctor noticed my gape was off, my right foot was stuck turned inward 2-3 inches and I have lost coordination in both hands. The doctor said these symptoms would go away after a matter of months.  Almost a year later I still have searing migraines, I still have the bells palsy, I still lack coordination in my hands and my right foot still is stuck inward about 2 inches. I own two restaurants and due to this medical issue I am no longer able to cook, drive or do the things to keep my businesses operating correctly like I did before receiving the vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Ear pain, Facial paralysis, Foot deformity
Clinical narrative: Several hours after receiving vaccine I noticed swelling on the right side of my neck. By the time I got home from lunch there was a half of a golf ball size lump on the side of my neck.  I was having difficulty swallowing. My right ear began to hurt.  I had another area swollen under my jaw line by 9pm.  I was very light headed.  That night I was cleaning and bent over--I felt like I was hit on my head and my head was tingling and I developed immense pain. I can't remember how long I was laying on the bed.  I finally went to sleep around midnight and when I woke up the lump on my neck was larger, the right side of my face was paralyzed and I had a painful migraine.   I did two virtual visits with Clinic.  They instructed me to go to the emergency room.  At the er they diagnosed me with bells palsy, the doctor noticed my gape was off, my right foot was stuck turned inward 2-3 inches and I have lost coordination in both hands. The doctor said these symptoms would go away after a matter of months.  Almost a year later I still have searing migraines, I still have the bells palsy, I still lack coordination in my hands and my right foot still is stuck inward about 2 inches. I own two restaurants and due to this medical issue I am no longer able to cook, drive or do the things to keep my businesses operating correctly like I did before receiving the vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Impaired driving ability, Impaired work ability, Migraine
Clinical narrative: Several hours after receiving vaccine I noticed swelling on the right side of my neck. By the time I got home from lunch there was a half of a golf ball size lump on the side of my neck.  I was having difficulty swallowing. My right ear began to hurt.  I had another area swollen under my jaw line by 9pm.  I was very light headed.  That night I was cleaning and bent over--I felt like I was hit on my head and my head was tingling and I developed immense pain. I can't remember how long I was laying on the bed.  I finally went to sleep around midnight and when I woke up the lump on my neck was larger, the right side of my face was paralyzed and I had a painful migraine.   I did two virtual visits with Clinic.  They instructed me to go to the emergency room.  At the er they diagnosed me with bells palsy, the doctor noticed my gape was off, my right foot was stuck turned inward 2-3 inches and I have lost coordination in both hands. The doctor said these symptoms would go away after a matter of months.  Almost a year later I still have searing migraines, I still have the bells palsy, I still lack coordination in my hands and my right foot still is stuck inward about 2 inches. I own two restaurants and due to this medical issue I am no longer able to cook, drive or do the things to keep my businesses operating correctly like I did before receiving the vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass, Paraesthesia, Swelling, Swelling face
Clinical narrative: Several hours after receiving vaccine I noticed swelling on the right side of my neck. By the time I got home from lunch there was a half of a golf ball size lump on the side of my neck.  I was having difficulty swallowing. My right ear began to hurt.  I had another area swollen under my jaw line by 9pm.  I was very light headed.  That night I was cleaning and bent over--I felt like I was hit on my head and my head was tingling and I developed immense pain. I can't remember how long I was laying on the bed.  I finally went to sleep around midnight and when I woke up the lump on my neck was larger, the right side of my face was paralyzed and I had a painful migraine.   I did two virtual visits with Clinic.  They instructed me to go to the emergency room.  At the er they diagnosed me with bells palsy, the doctor noticed my gape was off, my right foot was stuck turned inward 2-3 inches and I have lost coordination in both hands. The doctor said these symptoms would go away after a matter of months.  Almost a year later I still have searing migraines, I still have the bells palsy, I still lack coordination in my hands and my right foot still is stuck inward about 2 inches. I own two restaurants and due to this medical issue I am no longer able to cook, drive or do the things to keep my businesses operating correctly like I did before receiving the vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: Hoarseness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2021 (Lot number: EL3249) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot Number: EL1284.), administration date: 06Jan2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: DYSPHONIA (non-serious) with onset Jan2021, outcome "not recovered", described as "Hoarseness".  Additional information: Reporter seriousness for Hoarseness was Unspecified. Hoarseness was reported as worsened. The patient reported the possible side effect of hoarseness in the throat. She completed the vaccines in January. States that at time she would be hoarse maybe once a week and that lasted for four weeks. Says that now the hoarseness is every other day. States her symptoms had increased in frequency, symptoms started the week after her second dose of the Covid 19 Vaccine. The patient took Pfizer BioNTech Covid 19 Vaccine (Verbatim) because the patient works in (Privacy) doing clinical research, Covid trials; wanted protection. The patient denies having any medications, medical conditions, labs, testing, or treatments relevant to event. The patient had vaccination before Noon. No additional vaccines administered on Same Date of the Pfizer Suspect. AE(s) did not required a visit to Emergency Room/Physician Office. The patient had no other vaccines within 4 weeks Prior Vaccination. The patient had no AE(s) prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Swollen gland; slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Feb2021 09:30 (Lot number: EL3247) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure", start date: 2000 (ongoing), notes: High blood pr; "Anxiety", start date: 2014 (ongoing), notes: Anxiety+depr; "depression", start date: 2014 (ongoing), notes: Anxiety+depr; "degenerative bone disorder", start date: 2014 (ongoing), notes: Degenerative bone disorder; "Asthma", start date: 1998 (ongoing), notes: Asthma/COPD; "COPD", start date: 1998 (ongoing), notes: Asthma/COPD. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 03Feb2021 16:30, outcome "unknown", described as "Swollen gland"; HEADACHE (non-serious) with onset 03Feb2021 16:30, outcome "unknown", described as "slight headache".  Additional Information: Patient did not receive any Prior vaccinations. Vaccine not administered at facility.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Fatigue, Malaise, Nausea, Pain
Clinical narrative: nausea; aches/body aches; felt unwell; stomach physically hurting/lower stomach pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 25 year-old male patient received bnt162b2 (BNT162B2), administration date 02May2021 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea"; PAIN (non-serious), outcome "unknown", described as "aches/body aches"; MALAISE (non-serious), outcome "unknown", described as "felt unwell"; ABDOMINAL PAIN LOWER (non-serious), outcome "unknown", described as "stomach physically hurting/lower stomach pain"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional Information: The reporter called on behalf of her son who received the first dose of the Pfizer Covid-19 vaccine a week ago, on 02May2021, stated that he was still having side effects such as nausea, aches, and has felt unwell the past week. The reporter stated the symptoms are now less severe, but he is still experiencing achiness and his stomach physically hurting. The reporter stated the pain is in the lower stomach area and also mentioned that her son has been eating fine and they have a doctor's appointment today. The reporter was asking if there is anything that they can do to subside these symptoms and also asked how long does the reported symptoms last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Apr2021, outcome "recovered" (2021), described as "sore arm".  Additional information: Caller questioned that she had and still having side effect after the first dose of the vaccine. Should she get the second dose? And also, that she had a sore arm for 3 days as the rest of her family members, Caller asked how far apart can she postpone her second dose? The caller discussed about her husband and family. Caller does not provide identifying details for her family. Caller added that she got like the first three days just like her husband and kids and everybody got - a sore arm. Caller states that her husband and kids just had the normal - her husband and kids just had the normal - her husbands arm was sore for two days. Her kids are grown, and it did not bother them at all. Her grandkids did not have a reaction other than the arm is a little tender. She has no idea where she would do their report.Caller adds she got like the first three days just like her husband and kids and everybody got - a sore arm. Caller states that her husband and kids just had the normal - her husband's are was sore for two days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021523603 Same patient, different drug and event.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: so dizzy; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11May2021 (Lot number: EW0172) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "so dizzy"; HEADACHE (non-serious), outcome "unknown", described as "Headache". Additional information: This report was not related to a study or programme. The reporter stated that the headache has been killing her since Tuesday.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, COVID-19, Cardiac stress test, Electrocardiogram, Heart rate irregular
Clinical narrative: Irregular heartbeat- pounding, racing, profuse sweating even in the middle of the night. Still going on months later positive covid post vaccine, , Mentrual disregualtion, painful, heavy bleeding-prolonged several days, miscarriage post vaccine (november)
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Hyperhidrosis, Laboratory test, Menstruation irregular, Pain
Clinical narrative: Irregular heartbeat- pounding, racing, profuse sweating even in the middle of the night. Still going on months later positive covid post vaccine, , Mentrual disregualtion, painful, heavy bleeding-prolonged several days, miscarriage post vaccine (november)
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, SARS-CoV-2 test positive, X-ray
Clinical narrative: Irregular heartbeat- pounding, racing, profuse sweating even in the middle of the night. Still going on months later positive covid post vaccine, , Mentrual disregualtion, painful, heavy bleeding-prolonged several days, miscarriage post vaccine (november)
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: "had a little soreness" in their vaccinated arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as ""had a little soreness" in their vaccinated arms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Musculoskeletal disorder, Oedema peripheral, Pain
Clinical narrative: I've already reported this but the pain is getting worse!!!! I got my booster at work from the Regional hospital mobile van that set up vaccines at my job. I got the booster December 1st 2021. December 3rd 2021 my right armpit swelled so bad I felt like I was smuggling a softball under it! Since then I've had constant numbness from my elbow down to my ring and middle finger! It gets so numb sometimes,I'm unable to hold my 11 month old son! I can't use my arm sometimes to do my job! Everything was fine until I got the booster and my armpit swelled up! I've wrote you once and no response! I thought I was doing the right thing getting vaccinated and booster but if I knew this would happen I would never have done it! I want my arm and hand back normal but the government obviously doesn't care of the side effects it causes because it's been almost 3 months and I'm still living in pain from a damn covid booster!
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: pt presented to ED with c/o weakness, fever, cough, N/V/D x approximately 1 wk; admitted to ICU with telemetry after initial fluid resuscitation with continued borderline BP of 80s systolic; sepsis protocol; positive for COVID; treated with Actemra, remdesivir and corticosteroids; pt condition was a steady decline and he passed away in the hospital
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Cardiac telemetry, Cough, Death
Clinical narrative: pt presented to ED with c/o weakness, fever, cough, N/V/D x approximately 1 wk; admitted to ICU with telemetry after initial fluid resuscitation with continued borderline BP of 80s systolic; sepsis protocol; positive for COVID; treated with Actemra, remdesivir and corticosteroids; pt condition was a steady decline and he passed away in the hospital
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Diarrhoea, General physical health deterioration, Intensive care, Nausea, Pyrexia
Clinical narrative: pt presented to ED with c/o weakness, fever, cough, N/V/D x approximately 1 wk; admitted to ICU with telemetry after initial fluid resuscitation with continued borderline BP of 80s systolic; sepsis protocol; positive for COVID; treated with Actemra, remdesivir and corticosteroids; pt condition was a steady decline and he passed away in the hospital
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, Vomiting
Clinical narrative: pt presented to ED with c/o weakness, fever, cough, N/V/D x approximately 1 wk; admitted to ICU with telemetry after initial fluid resuscitation with continued borderline BP of 80s systolic; sepsis protocol; positive for COVID; treated with Actemra, remdesivir and corticosteroids; pt condition was a steady decline and he passed away in the hospital
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient received Pfizer COVID vaccine on 1/12/22. This was a booster dose for her. She received Moderna COVID vaccine for her first two doses. The day following her Pfizer booster, she developed chills and fever, soreness in her armpit, fatigue, and heart palpitations. She had chest pain which she described as pressure in the left middle chest. Cardiology was consulted and determined patients? picture to be consistent with acute myocarditis likely secondary to her COVID vaccine. ECG was without acute injury pattern, echocardiogram showed preserved ejection fraction and normal wall motion throughout. Trace amount of fluid was noted on follow-up limited echo and then repeat showed resolution of pericardial effusion. Troponin remained stable from admission at 0.08. Of note, patient does have history of lupus nephritis so could not be excluded that myocarditis could be lupus induced.  Cardiology recommended patient be treated with ibuprofen 600 mg three times daily for 1-2 weeks and colchicine 0.6mg twice daily for the next 90 days. Was determined to be stable and discharged home. Follow up appointment with cardiology after discharge showed patient to be improving with some occasional chest pains but no constant or persistent pains at this time. She continued to take ibuprofen as needed for intermittent pain and remains on colchicine.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary, Axillary pain, Chest X-ray, Chest discomfort, Chest pain
Clinical narrative: Patient received Pfizer COVID vaccine on 1/12/22. This was a booster dose for her. She received Moderna COVID vaccine for her first two doses. The day following her Pfizer booster, she developed chills and fever, soreness in her armpit, fatigue, and heart palpitations. She had chest pain which she described as pressure in the left middle chest. Cardiology was consulted and determined patients? picture to be consistent with acute myocarditis likely secondary to her COVID vaccine. ECG was without acute injury pattern, echocardiogram showed preserved ejection fraction and normal wall motion throughout. Trace amount of fluid was noted on follow-up limited echo and then repeat showed resolution of pericardial effusion. Troponin remained stable from admission at 0.08. Of note, patient does have history of lupus nephritis so could not be excluded that myocarditis could be lupus induced.  Cardiology recommended patient be treated with ibuprofen 600 mg three times daily for 1-2 weeks and colchicine 0.6mg twice daily for the next 90 days. Was determined to be stable and discharged home. Follow up appointment with cardiology after discharge showed patient to be improving with some occasional chest pains but no constant or persistent pains at this time. She continued to take ibuprofen as needed for intermittent pain and remains on colchicine.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Echocardiogram abnormal, Ejection fraction, Electrocardiogram normal, Fatigue
Clinical narrative: Patient received Pfizer COVID vaccine on 1/12/22. This was a booster dose for her. She received Moderna COVID vaccine for her first two doses. The day following her Pfizer booster, she developed chills and fever, soreness in her armpit, fatigue, and heart palpitations. She had chest pain which she described as pressure in the left middle chest. Cardiology was consulted and determined patients? picture to be consistent with acute myocarditis likely secondary to her COVID vaccine. ECG was without acute injury pattern, echocardiogram showed preserved ejection fraction and normal wall motion throughout. Trace amount of fluid was noted on follow-up limited echo and then repeat showed resolution of pericardial effusion. Troponin remained stable from admission at 0.08. Of note, patient does have history of lupus nephritis so could not be excluded that myocarditis could be lupus induced.  Cardiology recommended patient be treated with ibuprofen 600 mg three times daily for 1-2 weeks and colchicine 0.6mg twice daily for the next 90 days. Was determined to be stable and discharged home. Follow up appointment with cardiology after discharge showed patient to be improving with some occasional chest pains but no constant or persistent pains at this time. She continued to take ibuprofen as needed for intermittent pain and remains on colchicine.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Palpitations, Pericardial effusion, Pyrexia, Specialist consultation
Clinical narrative: Patient received Pfizer COVID vaccine on 1/12/22. This was a booster dose for her. She received Moderna COVID vaccine for her first two doses. The day following her Pfizer booster, she developed chills and fever, soreness in her armpit, fatigue, and heart palpitations. She had chest pain which she described as pressure in the left middle chest. Cardiology was consulted and determined patients? picture to be consistent with acute myocarditis likely secondary to her COVID vaccine. ECG was without acute injury pattern, echocardiogram showed preserved ejection fraction and normal wall motion throughout. Trace amount of fluid was noted on follow-up limited echo and then repeat showed resolution of pericardial effusion. Troponin remained stable from admission at 0.08. Of note, patient does have history of lupus nephritis so could not be excluded that myocarditis could be lupus induced.  Cardiology recommended patient be treated with ibuprofen 600 mg three times daily for 1-2 weeks and colchicine 0.6mg twice daily for the next 90 days. Was determined to be stable and discharged home. Follow up appointment with cardiology after discharge showed patient to be improving with some occasional chest pains but no constant or persistent pains at this time. She continued to take ibuprofen as needed for intermittent pain and remains on colchicine.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin normal
Clinical narrative: Patient received Pfizer COVID vaccine on 1/12/22. This was a booster dose for her. She received Moderna COVID vaccine for her first two doses. The day following her Pfizer booster, she developed chills and fever, soreness in her armpit, fatigue, and heart palpitations. She had chest pain which she described as pressure in the left middle chest. Cardiology was consulted and determined patients? picture to be consistent with acute myocarditis likely secondary to her COVID vaccine. ECG was without acute injury pattern, echocardiogram showed preserved ejection fraction and normal wall motion throughout. Trace amount of fluid was noted on follow-up limited echo and then repeat showed resolution of pericardial effusion. Troponin remained stable from admission at 0.08. Of note, patient does have history of lupus nephritis so could not be excluded that myocarditis could be lupus induced.  Cardiology recommended patient be treated with ibuprofen 600 mg three times daily for 1-2 weeks and colchicine 0.6mg twice daily for the next 90 days. Was determined to be stable and discharged home. Follow up appointment with cardiology after discharge showed patient to be improving with some occasional chest pains but no constant or persistent pains at this time. She continued to take ibuprofen as needed for intermittent pain and remains on colchicine.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID +
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID +
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal dreams, Anxiety, Blood test, Confusional state, Dysphonia
Clinical narrative: sore arms; tenderness in the left arm second dose; hoarse throat; Runny nose; his throat is scratchy and sore; his throat is scratchy and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171), administered in arm left, administration date 10May2021 at the age of 62 years as dose 2, single for covid-19 immunization. Relevant medical history included: "spleen removed", start date: 1995 (unspecified if ongoing), notes: Verbatim: spleen removed. Concomitant medication(s) included: VITAMIN D3 (ongoing). Vaccination history included: Bnt162b2 (First Dose: 20Apr2021), administration date: 20Apr2021, for Covid-19 Immunization; Flu (Name of the flu shot is Afluria PFS,2020-21 INJ 0.5mL.), administration date: Oct2020. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10May2021, outcome "unknown", described as "sore arms"; TENDERNESS (non-serious) with onset 10May2021, outcome "not recovered", described as "tenderness in the left arm second dose"; DYSPHONIA (non-serious) with onset 10May2021, outcome "not recovered", described as "hoarse throat"; RHINORRHOEA (non-serious) with onset 10May2021, outcome "not recovered", described as "Runny nose"; THROAT IRRITATION (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset 10May2021, outcome "unknown" and all described as "his throat is scratchy and sore".  No follow-up attempts are possible. No further information is expected.  Follow Up(11May2021): This is follow up spontaneous report from a contactable consumer.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Pain in extremity, Rhinorrhoea, Tenderness, Urine abnormality
Clinical narrative: sore arms; tenderness in the left arm second dose; hoarse throat; Runny nose; his throat is scratchy and sore; his throat is scratchy and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171), administered in arm left, administration date 10May2021 at the age of 62 years as dose 2, single for covid-19 immunization. Relevant medical history included: "spleen removed", start date: 1995 (unspecified if ongoing), notes: Verbatim: spleen removed. Concomitant medication(s) included: VITAMIN D3 (ongoing). Vaccination history included: Bnt162b2 (First Dose: 20Apr2021), administration date: 20Apr2021, for Covid-19 Immunization; Flu (Name of the flu shot is Afluria PFS,2020-21 INJ 0.5mL.), administration date: Oct2020. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10May2021, outcome "unknown", described as "sore arms"; TENDERNESS (non-serious) with onset 10May2021, outcome "not recovered", described as "tenderness in the left arm second dose"; DYSPHONIA (non-serious) with onset 10May2021, outcome "not recovered", described as "hoarse throat"; RHINORRHOEA (non-serious) with onset 10May2021, outcome "not recovered", described as "Runny nose"; THROAT IRRITATION (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset 10May2021, outcome "unknown" and all described as "his throat is scratchy and sore".  No follow-up attempts are possible. No further information is expected.  Follow Up(11May2021): This is follow up spontaneous report from a contactable consumer.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Oropharyngeal pain, Pain in extremity, Rhinorrhoea, Tenderness
Clinical narrative: sore arms; tenderness in the left arm second dose; hoarse throat; Runny nose; his throat is scratchy and sore; his throat is scratchy and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171), administered in arm left, administration date 10May2021 at the age of 62 years as dose 2, single for covid-19 immunization. Relevant medical history included: "spleen removed", start date: 1995 (unspecified if ongoing), notes: Verbatim: spleen removed. Concomitant medication(s) included: VITAMIN D3 (ongoing). Vaccination history included: Bnt162b2 (First Dose: 20Apr2021), administration date: 20Apr2021, for Covid-19 Immunization; Flu (Name of the flu shot is Afluria PFS,2020-21 INJ 0.5mL.), administration date: Oct2020. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10May2021, outcome "unknown", described as "sore arms"; TENDERNESS (non-serious) with onset 10May2021, outcome "not recovered", described as "tenderness in the left arm second dose"; DYSPHONIA (non-serious) with onset 10May2021, outcome "not recovered", described as "hoarse throat"; RHINORRHOEA (non-serious) with onset 10May2021, outcome "not recovered", described as "Runny nose"; THROAT IRRITATION (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset 10May2021, outcome "unknown" and all described as "his throat is scratchy and sore".  No follow-up attempts are possible. No further information is expected.  Follow Up(11May2021): This is follow up spontaneous report from a contactable consumer.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: sore arms; tenderness in the left arm second dose; hoarse throat; Runny nose; his throat is scratchy and sore; his throat is scratchy and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171), administered in arm left, administration date 10May2021 at the age of 62 years as dose 2, single for covid-19 immunization. Relevant medical history included: "spleen removed", start date: 1995 (unspecified if ongoing), notes: Verbatim: spleen removed. Concomitant medication(s) included: VITAMIN D3 (ongoing). Vaccination history included: Bnt162b2 (First Dose: 20Apr2021), administration date: 20Apr2021, for Covid-19 Immunization; Flu (Name of the flu shot is Afluria PFS,2020-21 INJ 0.5mL.), administration date: Oct2020. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10May2021, outcome "unknown", described as "sore arms"; TENDERNESS (non-serious) with onset 10May2021, outcome "not recovered", described as "tenderness in the left arm second dose"; DYSPHONIA (non-serious) with onset 10May2021, outcome "not recovered", described as "hoarse throat"; RHINORRHOEA (non-serious) with onset 10May2021, outcome "not recovered", described as "Runny nose"; THROAT IRRITATION (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset 10May2021, outcome "unknown" and all described as "his throat is scratchy and sore".  No follow-up attempts are possible. No further information is expected.  Follow Up(11May2021): This is follow up spontaneous report from a contactable consumer.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: Patient initially presented to the emergency room on 2/18/22 (day 6 post-Moderna booster/vaccine #3) with acute-onset headache, nausea, vomiting and was sent home after receiving initial supportive care with ondansetron 4 mg PO Q6H PRN nausea/vomiting, #10 tablets. He re-presented on 2/19/22 with new acute-onset substernal chest pain, epigastric pain, mild dyspnea, and cough found to have elevated high-sensitivity troponin up to 6,812.63. Serial troponins decreased within 24 hours and chest pain resolved with supportive measures (ketorolac/NSAID) and was discharged home uneventfully on 12/21/22.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Aspartate aminotransferase increased, Blood thyroid stimulating hormone normal, Brain natriuretic peptide normal, C-reactive protein increased
Clinical narrative: Patient initially presented to the emergency room on 2/18/22 (day 6 post-Moderna booster/vaccine #3) with acute-onset headache, nausea, vomiting and was sent home after receiving initial supportive care with ondansetron 4 mg PO Q6H PRN nausea/vomiting, #10 tablets. He re-presented on 2/19/22 with new acute-onset substernal chest pain, epigastric pain, mild dyspnea, and cough found to have elevated high-sensitivity troponin up to 6,812.63. Serial troponins decreased within 24 hours and chest pain resolved with supportive measures (ketorolac/NSAID) and was discharged home uneventfully on 12/21/22.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Echocardiogram, Ejection fraction
Clinical narrative: Patient initially presented to the emergency room on 2/18/22 (day 6 post-Moderna booster/vaccine #3) with acute-onset headache, nausea, vomiting and was sent home after receiving initial supportive care with ondansetron 4 mg PO Q6H PRN nausea/vomiting, #10 tablets. He re-presented on 2/19/22 with new acute-onset substernal chest pain, epigastric pain, mild dyspnea, and cough found to have elevated high-sensitivity troponin up to 6,812.63. Serial troponins decreased within 24 hours and chest pain resolved with supportive measures (ketorolac/NSAID) and was discharged home uneventfully on 12/21/22.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Headache, Metabolic function test, Metabolic function test normal, Nausea
Clinical narrative: Patient initially presented to the emergency room on 2/18/22 (day 6 post-Moderna booster/vaccine #3) with acute-onset headache, nausea, vomiting and was sent home after receiving initial supportive care with ondansetron 4 mg PO Q6H PRN nausea/vomiting, #10 tablets. He re-presented on 2/19/22 with new acute-onset substernal chest pain, epigastric pain, mild dyspnea, and cough found to have elevated high-sensitivity troponin up to 6,812.63. Serial troponins decreased within 24 hours and chest pain resolved with supportive measures (ketorolac/NSAID) and was discharged home uneventfully on 12/21/22.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate increased, Sinus arrhythmia, Thyroxine free normal, Troponin increased, Vomiting
Clinical narrative: Patient initially presented to the emergency room on 2/18/22 (day 6 post-Moderna booster/vaccine #3) with acute-onset headache, nausea, vomiting and was sent home after receiving initial supportive care with ondansetron 4 mg PO Q6H PRN nausea/vomiting, #10 tablets. He re-presented on 2/19/22 with new acute-onset substernal chest pain, epigastric pain, mild dyspnea, and cough found to have elevated high-sensitivity troponin up to 6,812.63. Serial troponins decreased within 24 hours and chest pain resolved with supportive measures (ketorolac/NSAID) and was discharged home uneventfully on 12/21/22.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: Patient initially presented to the emergency room on 2/18/22 (day 6 post-Moderna booster/vaccine #3) with acute-onset headache, nausea, vomiting and was sent home after receiving initial supportive care with ondansetron 4 mg PO Q6H PRN nausea/vomiting, #10 tablets. He re-presented on 2/19/22 with new acute-onset substernal chest pain, epigastric pain, mild dyspnea, and cough found to have elevated high-sensitivity troponin up to 6,812.63. Serial troponins decreased within 24 hours and chest pain resolved with supportive measures (ketorolac/NSAID) and was discharged home uneventfully on 12/21/22.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/No PQC; the vaccine was administered after a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 20-JAN-2022, the patient was administered with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (lot # U022321, expiration date: 15-JUL-2023, strength and route were unknown) after a temperature excursion for prophylaxis (product storage error). The vaccine was exposed to minus 14.1 degrees Celsius for 12 minutes. There was no previous excursion. No additional adverse event was reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no addtional AE/PQC reported; an expired dose of ROTATEQ was administered; This spontaneous report was received from a medical assistant referring to a 6 months old patient of unknown gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 21-JAN-2022, at the age of 6 months old, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (strength and dose not reported, lot # U007860, expiration date 14-JAN-2022) (expired product administered). No additional adverse event was reported.
Sex: M
Vaccine: COVID19
Symptoms: Mechanical ventilation
Clinical narrative: ON A VENTILATOR; This spontaneous report received from a consumer via a company representative in social media  concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received 2 doses of non-company suspect vaccine included Covid-19 vaccine (unspecified manufacturer), (dose number in series: 1) (Form, route of administration, batch number, dose were not reported, expiry: unknown) for prophylactic vaccination. No adverse events were reported following vaccination with Covid-19 vaccine (dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin was not reported, batch number: unknown), 1 total was administered, start therapy date was not reported, for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. On an unspecified date, the patient was on a vent (coded to on a ventilator) for over a month and nearly died (dose number in series: 2). As per the report "well chances are you wouldn't have died anyway. My brother in laws dad had both shots and a booster on a vent for over a month nearly died. A friends mom 67 and healthy within 3 days of second shot in the ground blood clots in legs and lungs and brain things that make you go hmmmm". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of on a ventilator was not reported. This report was serious (Life Threatening). This case, from the same reporter is linked to 20220230577.; Sender's Comments: V0: 20220230407- covid-19 vaccine ad26.cov2.s on a ventilator. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue
Clinical narrative: liquid from the vaccine running down arm / liquid leaked from vaccine needle; liquid from the vaccine running down arm / liquid leaked from vaccine needle; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) and DEVICE CONNECTION ISSUE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 14-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) and DEVICE CONNECTION ISSUE (liquid from the vaccine running down arm / liquid leaked from vaccine needle). At the time of the report, ACCIDENTAL UNDERDOSE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) and DEVICE CONNECTION ISSUE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Pharmacist took the needle out of the patient's arm and said the liquid from the vaccine came running down out of the arm down the chair. Also, pharmacist stuck the needle in, and its like it dripped all the way down the patient's elbow and down to the chair. Pharmacist was not sure how much came out, but said it seems like a lot came out. The patient had not experienced any symptoms. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Upon internal Review on 17-Feb-2022, significant correction was made to update event verbatim. On 16-Feb-2022: Followup received contains no new information