chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: booster; blood clot in right lung; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 36-year-old female patient received BNT162B2, administered in arm right, administration date 30Nov2021 (Batch/Lot number: unknown) at the age of 36 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "UTI", start date: Nov2021 (unspecified if ongoing), notes: 3 weeks ago, blood work: (Nov2021) urinary tract infection; "high blood pressure" (unspecified if ongoing). The patient took concomitant medications (high blood pressure). She did not have vaccination 4 weeks prior to COVID 19 Vaccine. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 30Nov2021, described as "booster"; PULMONARY THROMBOSIS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "blood clot in right lung". The patient took the Pfizer shot and developed blood clot in the lungs, stated that "it almost killed me." So, patient was making a complaint about this shot. She just got out of the hospital. Further stated, "almost took my life, you almost took my life.. almost died from this shot." She come from being healthy to now, got to take the blood thinner (treatment) for 6 months because she took this shot. She got admitted in hospital; she developed blood clot and stayed in hospital and got medicine every time. She was on everything, on blood thinner. Now, almost 2 months for the blood clots to leave.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Immunisation, Pulmonary thrombosis
Clinical narrative: booster; blood clot in right lung; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 36-year-old female patient received BNT162B2, administered in arm right, administration date 30Nov2021 (Batch/Lot number: unknown) at the age of 36 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "UTI", start date: Nov2021 (unspecified if ongoing), notes: 3 weeks ago, blood work: (Nov2021) urinary tract infection; "high blood pressure" (unspecified if ongoing). The patient took concomitant medications (high blood pressure). She did not have vaccination 4 weeks prior to COVID 19 Vaccine. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 30Nov2021, described as "booster"; PULMONARY THROMBOSIS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "blood clot in right lung". The patient took the Pfizer shot and developed blood clot in the lungs, stated that "it almost killed me." So, patient was making a complaint about this shot. She just got out of the hospital. Further stated, "almost took my life, you almost took my life.. almost died from this shot." She come from being healthy to now, got to take the blood thinner (treatment) for 6 months because she took this shot. She got admitted in hospital; she developed blood clot and stayed in hospital and got medicine every time. She was on everything, on blood thinner. Now, almost 2 months for the blood clots to leave.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Arthralgia, Asthenia, Balance disorder, Chills
Clinical narrative: heart pain; weakness; dizzy; joint pain; loss of flexibility; loss of flexibility, pain under right arm then pain went to right should blade/has lost flexibility; loss of flexibility/has lost flexibility and now struggles with balance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 13-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Nov2021 18:15 (Lot number: 330-3080D) at the age of 13 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "tree nut allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ANGINA PECTORIS (medically significant) with onset 27Nov2021, outcome "not recovered", described as "heart pain"; ASTHENIA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "weakness"; DIZZINESS (non-serious) with onset 27Nov2021, outcome "not recovered", described as "dizzy"; ARTHRALGIA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "joint pain"; MUSCLE DISORDER (non-serious) with onset 27Nov2021, outcome "not recovered", described as "loss of flexibility"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "not recovered", described as "loss of flexibility, pain under right arm then pain went to right should blade/has lost flexibility"; BALANCE DISORDER (non-serious) with onset 27Nov2021, outcome "not recovered", described as "loss of flexibility/has lost flexibility and now struggles with balance". Therapeutic measures were not taken as a result of angina pectoris, asthenia, dizziness, arthralgia, muscle disorder, pain in extremity, balance disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. None of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: heart pain; weakness; dizzy; joint pain; loss of flexibility; loss of flexibility, pain under right arm then pain went to right should blade/has lost flexibility; loss of flexibility/has lost flexibility and now struggles with balance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 13-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Nov2021 18:15 (Lot number: 330-3080D) at the age of 13 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "tree nut allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ANGINA PECTORIS (medically significant) with onset 27Nov2021, outcome "not recovered", described as "heart pain"; ASTHENIA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "weakness"; DIZZINESS (non-serious) with onset 27Nov2021, outcome "not recovered", described as "dizzy"; ARTHRALGIA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "joint pain"; MUSCLE DISORDER (non-serious) with onset 27Nov2021, outcome "not recovered", described as "loss of flexibility"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "not recovered", described as "loss of flexibility, pain under right arm then pain went to right should blade/has lost flexibility"; BALANCE DISORDER (non-serious) with onset 27Nov2021, outcome "not recovered", described as "loss of flexibility/has lost flexibility and now struggles with balance". Therapeutic measures were not taken as a result of angina pectoris, asthenia, dizziness, arthralgia, muscle disorder, pain in extremity, balance disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. None of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Arthralgia, Asthenia, Balance disorder, Dizziness
Clinical narrative: heart pain; weakness; dizzy; joint pain; loss of flexibility; loss of flexibility, pain under right arm then pain went to right should blade/has lost flexibility; loss of flexibility/has lost flexibility and now struggles with balance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 13-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Nov2021 18:15 (Lot number: 330-3080D) at the age of 13 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "tree nut allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ANGINA PECTORIS (medically significant) with onset 27Nov2021, outcome "not recovered", described as "heart pain"; ASTHENIA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "weakness"; DIZZINESS (non-serious) with onset 27Nov2021, outcome "not recovered", described as "dizzy"; ARTHRALGIA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "joint pain"; MUSCLE DISORDER (non-serious) with onset 27Nov2021, outcome "not recovered", described as "loss of flexibility"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "not recovered", described as "loss of flexibility, pain under right arm then pain went to right should blade/has lost flexibility"; BALANCE DISORDER (non-serious) with onset 27Nov2021, outcome "not recovered", described as "loss of flexibility/has lost flexibility and now struggles with balance". Therapeutic measures were not taken as a result of angina pectoris, asthenia, dizziness, arthralgia, muscle disorder, pain in extremity, balance disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. None of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle disorder, Pain in extremity
Clinical narrative: heart pain; weakness; dizzy; joint pain; loss of flexibility; loss of flexibility, pain under right arm then pain went to right should blade/has lost flexibility; loss of flexibility/has lost flexibility and now struggles with balance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 13-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Nov2021 18:15 (Lot number: 330-3080D) at the age of 13 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "tree nut allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ANGINA PECTORIS (medically significant) with onset 27Nov2021, outcome "not recovered", described as "heart pain"; ASTHENIA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "weakness"; DIZZINESS (non-serious) with onset 27Nov2021, outcome "not recovered", described as "dizzy"; ARTHRALGIA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "joint pain"; MUSCLE DISORDER (non-serious) with onset 27Nov2021, outcome "not recovered", described as "loss of flexibility"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "not recovered", described as "loss of flexibility, pain under right arm then pain went to right should blade/has lost flexibility"; BALANCE DISORDER (non-serious) with onset 27Nov2021, outcome "not recovered", described as "loss of flexibility/has lost flexibility and now struggles with balance". Therapeutic measures were not taken as a result of angina pectoris, asthenia, dizziness, arthralgia, muscle disorder, pain in extremity, balance disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. None of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Echocardiogram normal, Laboratory test normal, SARS-CoV-2 test negative
Clinical narrative: booster; I got a reaction right there and that was coughing; I can't stop coughing; Started to have trouble breathing; injection site pain; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Nov2021 (Lot number: FH8028) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Seizure" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL taken for seizure; DIAZEPAM taken for anxiety; VISTARIL [HYDROXYZINE EMBONATE] taken for anxiety. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: ENS318), administration date: 03Mar2021, when the patient was 62 years old, for Covid-19 Immunization; Bnt162b2 (Dose: 2, Lot Number: CN6707), administration date: 24Mar2021, when the patient was 62 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 11Nov2021, outcome "unknown", described as "booster"; DYSPNOEA (hospitalization) with onset Nov2021, outcome "unknown", described as "Started to have trouble breathing"; COUGH (hospitalization) with onset 11Nov2021, outcome "not recovered", described as "I got a reaction right there and that was coughing; I can't stop coughing"; VACCINATION SITE PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "injection site pain". The patient was hospitalized for immunisation, dyspnoea, cough (hospitalization duration: 6 day(s)). The patient underwent the following laboratory tests and procedures: computerised tomogram: unknown results; sars-cov-2 test: negative, notes: She tested negative for COVID every time. Therapeutic measures were taken as a result of dyspnoea, cough, vaccination site pain.  Caller states that she is taking medication to relieve her cough and they help for a little bit but it wears off for 4 hours and is disrupting her sleep. Caller states that it's making her feel exhausted.    No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Cough, Dyspnoea, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; I got a reaction right there and that was coughing; I can't stop coughing; Started to have trouble breathing; injection site pain; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Nov2021 (Lot number: FH8028) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Seizure" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL taken for seizure; DIAZEPAM taken for anxiety; VISTARIL [HYDROXYZINE EMBONATE] taken for anxiety. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: ENS318), administration date: 03Mar2021, when the patient was 62 years old, for Covid-19 Immunization; Bnt162b2 (Dose: 2, Lot Number: CN6707), administration date: 24Mar2021, when the patient was 62 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 11Nov2021, outcome "unknown", described as "booster"; DYSPNOEA (hospitalization) with onset Nov2021, outcome "unknown", described as "Started to have trouble breathing"; COUGH (hospitalization) with onset 11Nov2021, outcome "not recovered", described as "I got a reaction right there and that was coughing; I can't stop coughing"; VACCINATION SITE PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "injection site pain". The patient was hospitalized for immunisation, dyspnoea, cough (hospitalization duration: 6 day(s)). The patient underwent the following laboratory tests and procedures: computerised tomogram: unknown results; sars-cov-2 test: negative, notes: She tested negative for COVID every time. Therapeutic measures were taken as a result of dyspnoea, cough, vaccination site pain.  Caller states that she is taking medication to relieve her cough and they help for a little bit but it wears off for 4 hours and is disrupting her sleep. Caller states that it's making her feel exhausted.    No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: booster; I got a reaction right there and that was coughing; I can't stop coughing; Started to have trouble breathing; injection site pain; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Nov2021 (Lot number: FH8028) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Seizure" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL taken for seizure; DIAZEPAM taken for anxiety; VISTARIL [HYDROXYZINE EMBONATE] taken for anxiety. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: ENS318), administration date: 03Mar2021, when the patient was 62 years old, for Covid-19 Immunization; Bnt162b2 (Dose: 2, Lot Number: CN6707), administration date: 24Mar2021, when the patient was 62 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 11Nov2021, outcome "unknown", described as "booster"; DYSPNOEA (hospitalization) with onset Nov2021, outcome "unknown", described as "Started to have trouble breathing"; COUGH (hospitalization) with onset 11Nov2021, outcome "not recovered", described as "I got a reaction right there and that was coughing; I can't stop coughing"; VACCINATION SITE PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "injection site pain". The patient was hospitalized for immunisation, dyspnoea, cough (hospitalization duration: 6 day(s)). The patient underwent the following laboratory tests and procedures: computerised tomogram: unknown results; sars-cov-2 test: negative, notes: She tested negative for COVID every time. Therapeutic measures were taken as a result of dyspnoea, cough, vaccination site pain.  Caller states that she is taking medication to relieve her cough and they help for a little bit but it wears off for 4 hours and is disrupting her sleep. Caller states that it's making her feel exhausted.    No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Erythema multiforme, Intensive care, Pyrexia, Rash erythematous
Clinical narrative: atypical kawasaki: prolonged fever, rash, mucositis, conjunctivitis, shock, elevated d-dimer, elevated troponin, elevated BNP, dilated coronary arteries, acute kidney injury, coagulopathy, hepatomegaly.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Shock
Clinical narrative: atypical kawasaki: prolonged fever, rash, mucositis, conjunctivitis, shock, elevated d-dimer, elevated troponin, elevated BNP, dilated coronary arteries, acute kidney injury, coagulopathy, hepatomegaly.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Blood creatinine increased, Blood culture negative, Brain natriuretic peptide increased, Coagulopathy
Clinical narrative: atypical kawasaki: prolonged fever, rash, mucositis, conjunctivitis, shock, elevated d-dimer, elevated troponin, elevated BNP, dilated coronary arteries, acute kidney injury, coagulopathy, hepatomegaly.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Conjunctivitis, Coronary artery dilatation, Echocardiogram abnormal, Fibrin D dimer increased, Hepatomegaly
Clinical narrative: atypical kawasaki: prolonged fever, rash, mucositis, conjunctivitis, shock, elevated d-dimer, elevated troponin, elevated BNP, dilated coronary arteries, acute kidney injury, coagulopathy, hepatomegaly.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Kawasaki's disease, Mucosal inflammation, Pyrexia, Rash, SARS-CoV-2 antibody test negative
Clinical narrative: atypical kawasaki: prolonged fever, rash, mucositis, conjunctivitis, shock, elevated d-dimer, elevated troponin, elevated BNP, dilated coronary arteries, acute kidney injury, coagulopathy, hepatomegaly.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Shock, Troponin increased
Clinical narrative: atypical kawasaki: prolonged fever, rash, mucositis, conjunctivitis, shock, elevated d-dimer, elevated troponin, elevated BNP, dilated coronary arteries, acute kidney injury, coagulopathy, hepatomegaly.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster vaccine administered on 12/03/2021, was not due until 12/24/2021
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Rash
Clinical narrative: Injection site began burning and becoming hot with swelling in 24 hours.  Hives began to form on 12/5/21 and spread slowly until 12/8/21, when the  hives covered whole body.  Joint pain, swelling of the face, burning rash, hives continued until steroid dose day two on 12/9/21.  Rash subsided over 5 days and injection site calmed.  On 12/16/21 steroid dose has been completed for ~48 hours.  Rash began on chest, hot to touch, full body rash within 5 hours.  Tongue, lips, and mouth tingling and swelling.  Face swelling, nausea, and dizzyness continued until steroid given in ER at ~8:00 on 12/16/21.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Dizziness, Injection site pain, Injection site swelling
Clinical narrative: Injection site began burning and becoming hot with swelling in 24 hours.  Hives began to form on 12/5/21 and spread slowly until 12/8/21, when the  hives covered whole body.  Joint pain, swelling of the face, burning rash, hives continued until steroid dose day two on 12/9/21.  Rash subsided over 5 days and injection site calmed.  On 12/16/21 steroid dose has been completed for ~48 hours.  Rash began on chest, hot to touch, full body rash within 5 hours.  Tongue, lips, and mouth tingling and swelling.  Face swelling, nausea, and dizzyness continued until steroid given in ER at ~8:00 on 12/16/21.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth, Lip swelling, Mouth swelling, Nausea, Paraesthesia oral
Clinical narrative: Injection site began burning and becoming hot with swelling in 24 hours.  Hives began to form on 12/5/21 and spread slowly until 12/8/21, when the  hives covered whole body.  Joint pain, swelling of the face, burning rash, hives continued until steroid dose day two on 12/9/21.  Rash subsided over 5 days and injection site calmed.  On 12/16/21 steroid dose has been completed for ~48 hours.  Rash began on chest, hot to touch, full body rash within 5 hours.  Tongue, lips, and mouth tingling and swelling.  Face swelling, nausea, and dizzyness continued until steroid given in ER at ~8:00 on 12/16/21.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Skin warm, Swelling face, Swollen tongue, Urticaria
Clinical narrative: Injection site began burning and becoming hot with swelling in 24 hours.  Hives began to form on 12/5/21 and spread slowly until 12/8/21, when the  hives covered whole body.  Joint pain, swelling of the face, burning rash, hives continued until steroid dose day two on 12/9/21.  Rash subsided over 5 days and injection site calmed.  On 12/16/21 steroid dose has been completed for ~48 hours.  Rash began on chest, hot to touch, full body rash within 5 hours.  Tongue, lips, and mouth tingling and swelling.  Face swelling, nausea, and dizzyness continued until steroid given in ER at ~8:00 on 12/16/21.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Injection site urticaria, Pyrexia, SARS-CoV-2 test negative, Urticaria
Clinical narrative: HIVES- IT LASTED FOR 16 TO 24HOURS
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Skin test positive, Urticaria
Clinical narrative: HIVES- IT LASTED FOR 16 TO 24HOURS
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein normal, Chest pain, Electrocardiogram normal, Magnetic resonance imaging heart, Malaise
Clinical narrative: Myocarditis
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Red blood cell sedimentation rate normal, Troponin I increased, Vomiting
Clinical narrative: Myocarditis
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Myocarditis, Troponin abnormal
Clinical narrative: Myocarditis
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Fatigue, myalgias, HA, right flank pain, RLQ cramps, constipation, sore arm, nausea, indigestion started an progressed on day of vaccine.  12/17: Flank pain gone, nausea and indigestion improved but not resolved.  Constipation worse. Bloating, mild diffuse abd discomfort. No f/c/s.  Fatigue persists.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Blood creatinine increased, Blood urea normal
Clinical narrative: Fatigue, myalgias, HA, right flank pain, RLQ cramps, constipation, sore arm, nausea, indigestion started an progressed on day of vaccine.  12/17: Flank pain gone, nausea and indigestion improved but not resolved.  Constipation worse. Bloating, mild diffuse abd discomfort. No f/c/s.  Fatigue persists.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Computerised tomogram abdomen abnormal, Condition aggravated, Constipation, Differential white blood cell count normal
Clinical narrative: Fatigue, myalgias, HA, right flank pain, RLQ cramps, constipation, sore arm, nausea, indigestion started an progressed on day of vaccine.  12/17: Flank pain gone, nausea and indigestion improved but not resolved.  Constipation worse. Bloating, mild diffuse abd discomfort. No f/c/s.  Fatigue persists.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspepsia, Fatigue, Flank pain, Full blood count, Haematocrit normal
Clinical narrative: Fatigue, myalgias, HA, right flank pain, RLQ cramps, constipation, sore arm, nausea, indigestion started an progressed on day of vaccine.  12/17: Flank pain gone, nausea and indigestion improved but not resolved.  Constipation worse. Bloating, mild diffuse abd discomfort. No f/c/s.  Fatigue persists.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haemoglobin normal, Headache, Human chorionic gonadotropin normal, Metabolic function test, Myalgia
Clinical narrative: Fatigue, myalgias, HA, right flank pain, RLQ cramps, constipation, sore arm, nausea, indigestion started an progressed on day of vaccine.  12/17: Flank pain gone, nausea and indigestion improved but not resolved.  Constipation worse. Bloating, mild diffuse abd discomfort. No f/c/s.  Fatigue persists.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Ovarian cyst, Pain in extremity, Platelet count normal, Red blood cell sedimentation rate normal
Clinical narrative: Fatigue, myalgias, HA, right flank pain, RLQ cramps, constipation, sore arm, nausea, indigestion started an progressed on day of vaccine.  12/17: Flank pain gone, nausea and indigestion improved but not resolved.  Constipation worse. Bloating, mild diffuse abd discomfort. No f/c/s.  Fatigue persists.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urine analysis normal, White blood cell count normal
Clinical narrative: Fatigue, myalgias, HA, right flank pain, RLQ cramps, constipation, sore arm, nausea, indigestion started an progressed on day of vaccine.  12/17: Flank pain gone, nausea and indigestion improved but not resolved.  Constipation worse. Bloating, mild diffuse abd discomfort. No f/c/s.  Fatigue persists.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling jittery, Hyperventilation
Clinical narrative: Pt stayed in the office for about 50 minutes. myself and the on call provider, AM were monitoring her. Pt had chills, jitters, and a bit of hyperventilation. States this happened last time as well. Pt states her body just needed time to adjust to it. After 50 minutes she was feeling much better. Checked her BP twice per AM request. It was lower the second time. No other concerns.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: BURNS MORE AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (manufacturer unspecified - dose series 1). The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date the patient experienced injection burnt a bit (injection site burning).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the event of injection burnt a bit was not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (dose series 2). The batch number was not reported and has been requested. On an unspecified date the patient experienced burns more at injection site (injection site burning) compared to the initial dose.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site burning was not reported. This report was non-serious. This case, involving the same patient is linked to 20211214174.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Pain
Clinical narrative: Ongoing and progressively worsening left arm pain that is also causing limited range of motion of the arm that begin a few days ago. Left arm pain has ongoing since vaccination date with no relief of symptoms. Client has tried OTC Tylenol with mild relief. Even with limited range of motion of the left arm, client reports continued arm pain. Encouraged client to seek medical evaluation for further follow-up.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Ongoing and progressively worsening left arm pain that is also causing limited range of motion of the arm that begin a few days ago. Left arm pain has ongoing since vaccination date with no relief of symptoms. Client has tried OTC Tylenol with mild relief. Even with limited range of motion of the left arm, client reports continued arm pain. Encouraged client to seek medical evaluation for further follow-up.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Patient came a few days after her booster shot reporting a red, swollen arm from her shoulder to her forearm. Red, warm to the touch and swollen. Swelling has reduced since it began but the arm is still very red and painful
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient came a few days after her booster shot reporting a red, swollen arm from her shoulder to her forearm. Red, warm to the touch and swollen. Swelling has reduced since it began but the arm is still very red and painful
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: None noted or reported at the time of the event. No adverse outcomes and or signs/symptoms noted at the time of the event or after.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Pain in extremity, Speech disorder, Tongue disorder
Clinical narrative: patient developed dysarthria, dysphagia. Findings on MRI are concerning for acute disseminated encephalomyelitis (ADEM). Improved with high dose Solumedrol 1g IV x 5 days. Will follow up closely with outpatient neurology for further pending results.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: CSF protein increased, Dysarthria, Dysphagia, Magnetic resonance imaging abnormal, Nucleated red cells
Clinical narrative: patient developed dysarthria, dysphagia. Findings on MRI are concerning for acute disseminated encephalomyelitis (ADEM). Improved with high dose Solumedrol 1g IV x 5 days. Will follow up closely with outpatient neurology for further pending results.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Rash
Clinical narrative: Tingling sensation all over body; felt numb/weird sensation in arms and legs/foot felt numb/numbness in left leg/numbness in left arm/numbness in right side of face (cheek and tongue); Rash all over body; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation all over body), HYPOAESTHESIA (felt numb/weird sensation in arms and legs/foot felt numb/numbness in left leg/numbness in left arm/numbness in right side of face (cheek and tongue)) and RASH (Rash all over body) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Jun-2022. On 30-Mar-2021, the patient experienced PARAESTHESIA (Tingling sensation all over body) and RASH (Rash all over body). 30-Mar-2021, the patient experienced HYPOAESTHESIA (felt numb/weird sensation in arms and legs/foot felt numb/numbness in left leg/numbness in left arm/numbness in right side of face (cheek and tongue)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling sensation all over body), HYPOAESTHESIA (felt numb/weird sensation in arms and legs/foot felt numb/numbness in left leg/numbness in left arm/numbness in right side of face (cheek and tongue)) and RASH (Rash all over body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication were provided On 30-Mar-2021 the symptoms started and went on and off for three months. Post that patient recovered; however, afraid of getting Moderna Vaccine. Patient had last menstrual period on 18Sep2021.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: more than typical (for vaccinations) pain in the arm into which it was administered; a raise/swollen area at the injection site; wake up throughout the night from it; it had gone into my right arm; This spontaneous report was received from a female patient of unknown age referring to herself. Information about medical history and concurrent condition was unknown. Concomitant vaccine included  influenza vaccine (FLU).    On 26-OCT-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis.         On the same day, the patient experienced more than typical (for vaccinations) pain in the arm into which it was administered that persisted for over a week; the pain was bad enough that the patient would wake up throughout the night from it, could not sleep on the right side (it had gone into the patient's right arm), and was in pain when the patient shifted body at all in the bed while trying to sleep. Additionally, there was a hard, raised/swollen area at the injection site that persisted for a similar length of time. All symptoms experienced after receiving this vaccination had since gone away completely. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown. The outcome of the events was resolved on an unknown date in 2021.      The causality between all events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperautre excursion 1C; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-NOV-2021, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) lot # T031202, expiration date 14-JUN-2022, dose of 0.5 milliliter (formulation, strength, anatomical location and route of administration were not reported) for prophylaxis (product storage error). There was no other adverse event. The temperature excursion was reported as 1 degree Celsius (C) for 40 minutes. There was no other excursion reported. The outcome was unknown. ; Sender's Comments:  US-009507513-2111USA006649:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no AE; expired dose of VARIVAX administered; This spontaneous report was received from an office manager and refers to a patient of unknown age. The patient's medical history was not reported.  On 16-NOV-2021, the patient was vaccinated with and expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S033539, expiration date 22-OCT-2021, 0.5 milliliter, subcutaneously for prophylaxis.  No additional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; administered the second dose of VAQTA on 17NOV2021; however the dose was not due to be administered until 25NOV2021; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On an unknown date, the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, lot #, expiration date, route and site of administration were not reported) for prophylaxis.  On 17-NOV-2021, the patient was vaccinated with the second dose of Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 milliliter, lot # T031202 was confirmed to be valid, expiration date 14-JUN-2022, (route and site of administration were not reported) for prophylaxis, however the second dose was not due to be administered until 25-NOV-2021 (Inappropriate schedule of vaccine administered). No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired MMR II was administered; This spontaneous report was received from a clinical office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 22-NOV-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II), 0.5 milliliter, lot # S037501, expiry date 20-NOV-2021 for prophylaxis (route of administration was not provided) (expired product administered). The vaccine did not experience any temperature excursions. No additional adverse event or product quality complaint was reported.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: nO ADDITIONAL ADVERSE EVENT REPORTED; consumer received the GARDASIL-9 vaccine while pregnant.; This spontaneous pregnancy report has been received from a nurse via a company representative, referring to a 21 years-old female patient. The last menstrual period was not reported. At the reporting time the patient had 16 gestation weeks. The pregnancy outcome was unknown. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-NOV-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # U008897, expiration date on 16-MAY-2023 (anatomical location and administration route were not reported) for prophylaxis.  The reporter stated that the patient received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) while pregnant. No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; Gardasil 9 was administered during temperature excursion; This spontaneous report was received from a  licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-NOV-2021, the patient was vaccinated an improperly stored (product storage error) dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # T030749, expiration date 16-MAR-2023 (dose, route and site of administration were not provided) for prophylaxis. No additional information about the temperature excursion involving suspect vaccine was provided. No additional adverse event was reported (no adverse event).
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from a nurse and refers to a 27-year-old female patient. The patient's concurrent conditions included immunodeficiency. The patient's medical history included kidney transplant she received as a toddler. There was no drug reactions or allergies reported. Concomitant therapy included sulfamethoxazole, trimethoprim (BACTRIM), azathioprine(IMURAN [AZATHIOPRINE]), intrauterine contraceptive device(PARAGARD T380A), prednisone, montelukast sodium(SINGULAIR) and lisdexamfetamine mesilate(VYVANSE). In approximately 2016 (reported as approximately 5 years ago), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml, intravenously (anatomical location, lot number and expiration date were not reported) as Human papillomavirus (HPV) vaccination. The nurse reported that the patient went to her dermatologist who confirmed she had warts on her hands (skin papilloma); the exact date of the dermatology appointment was unknown. It was reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series was completed prior to confirmed case of warts. There were no specific details about treatment since the reporter practice was not the treating provider. At the time of the report, the outcome of the event was unknown. The relatedness between the event of skin papilloma and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no AE; patient was administered PEDV AXHIB after a temperature excursion; This spontaneous report was received from a HBP to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 18-NOV-2021, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # T037650 verified to be valid with expiration date: 21-JUL-2023) in dose 0 .5 milliliter (dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperature to which the vaccine was exposed was 47.29 degrees of Fahrenheit (F) and the time frame was reported as 3 hours 22 minutes.. It was unknown if a digital data logger was involved. No adverse symptoms were reported.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a nurse via company representative, concerning a 12-year-old male patient. Information regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies was unknown by reporter.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at a dose of 0.5 milliliter (ml), by intramuscular route (IM) (frequency, anatomical location, vaccination scheme, lot number and expiration date were not reported).  On an unknown date, the patient passed out (loss of consciousness). It was unknown if the patient sought medical attention, if he received a treatment for the event or had any laboratory diagnostics or studies performed.  At the time of the report, the outcome of the event was unknown.  Causality assessment was not provided by the reporter.     Upon internal review, the event of loss of consciousness was determined to be medically significant.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA004378:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: No additional AE reported; Patient was administered PROQUAD and VARIVAX on same day; This spontaneous report was received from a nurse referred to a 12-months-old patient. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 14-DEC-2021 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD),0.5 milliliter, (lot # T036565 and expiration date reported as 26-APR-2022) and varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 milliliter, (lot # T029533 and expiration date reported as 01-SEP-2022) on same day for prophylaxis (overdose). No Additional information provided. No additional AE and PQC reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided. On 13-DEC-2021, the patient was vaccinated orally with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, lot # 1821791, expiration date: 26-JUL-2022, for prophylaxis. Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was improperly stored for 3 hours and 15 minutes in 9 degree Celsius (product storage error). There was no any previous temperature excursion.