chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Tension headache, Vertigo, Vestibular migraine
Clinical narrative: off balance; tension headaches; diagnosed with vestibular migranes; heart rate slightly elevated; blood pressure slightly elevated; States not getting enough sleep; vertigo; dizziness; Episodes of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (off balance), TENSION HEADACHE (tension headaches), VESTIBULAR MIGRAINE (diagnosed with vestibular migranes), HEART RATE INCREASED (heart rate slightly elevated) and BLOOD PRESSURE INCREASED (blood pressure slightly elevated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (off balance), TENSION HEADACHE (tension headaches), VESTIBULAR MIGRAINE (diagnosed with vestibular migranes), HEART RATE INCREASED (heart rate slightly elevated), BLOOD PRESSURE INCREASED (blood pressure slightly elevated), INSOMNIA (States not getting enough sleep), VERTIGO (vertigo), DIZZINESS (dizziness) and FATIGUE (Episodes of fatigue). The patient was treated with LORAZEPAM (ATIVAN) ongoing since an unknown date at an unspecified dose and frequency and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) ongoing since an unknown date at a dose of 75 mg then to raise to 150mg after 1 month. At the time of the report, BALANCE DISORDER (off balance), TENSION HEADACHE (tension headaches), VESTIBULAR MIGRAINE (diagnosed with vestibular migranes), HEART RATE INCREASED (heart rate slightly elevated), BLOOD PRESSURE INCREASED (blood pressure slightly elevated), INSOMNIA (States not getting enough sleep), VERTIGO (vertigo), DIZZINESS (dizziness) and FATIGUE (Episodes of fatigue) outcome was unknown.            The patient reported heart rate and blood pressure slightly elevated but not as bad as after the 1st dose. Further he went to physical therapist to rule out vertigo and went to ENT doctor. The Sunlight Triger  the headache event.  the Ativan medication was taken 15 min prior to receiving 2nd dose. The treatment was for 6 months. The patient has no COVID-19 infection previously.   This case was linked to MOD-2022-467546 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Cardiogenic shock, Chest tube insertion, Death, Feeding disorder
Clinical narrative: Narrative: 79yo male patient in home health contacted facility to inform pt had died at outside facility on 1/8/22. See info below about pt's death from provider's chart noted dated 1/10/22 which came from non-facility medical record: "Date of Service: 12/26/2021-1/8/2022 Name of Facility: Inpatient reason for hospitalization pleural effusion, septic shock, hospital acquired pneumonia, pleux catherer placed 12/28/2021, continued antibiotics withotu improvement, not much drainage from catheter, persistent hypotension treated albumin, midrodrine, phenylephrine drip for days, could not eat or tolerate tube feeds egd/peg exchanee 1/3/2022 unfortunately multisystem organ failure, despite maximal resuscitative efforts began bradycardia arrhythmias, family elected to make him dnr comfort care, passed peacefully with family and several hospital staff, cause of death refractory cardiogenic shock 1/8/2022 8:46am "Pt had received covid vaccines from non-facility site on 2/9/21 & 3/10/21. Likely pt's death is not related to covid vaccines given pt's advanced age, information about pt's death provided, and long length of time between death & date of vaccine administrations.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Multiple organ dysfunction syndrome, Pleural effusion, Pneumonia, Resuscitation
Clinical narrative: Narrative: 79yo male patient in home health contacted facility to inform pt had died at outside facility on 1/8/22. See info below about pt's death from provider's chart noted dated 1/10/22 which came from non-facility medical record: "Date of Service: 12/26/2021-1/8/2022 Name of Facility: Inpatient reason for hospitalization pleural effusion, septic shock, hospital acquired pneumonia, pleux catherer placed 12/28/2021, continued antibiotics withotu improvement, not much drainage from catheter, persistent hypotension treated albumin, midrodrine, phenylephrine drip for days, could not eat or tolerate tube feeds egd/peg exchanee 1/3/2022 unfortunately multisystem organ failure, despite maximal resuscitative efforts began bradycardia arrhythmias, family elected to make him dnr comfort care, passed peacefully with family and several hospital staff, cause of death refractory cardiogenic shock 1/8/2022 8:46am "Pt had received covid vaccines from non-facility site on 2/9/21 & 3/10/21. Likely pt's death is not related to covid vaccines given pt's advanced age, information about pt's death provided, and long length of time between death & date of vaccine administrations.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Septic shock
Clinical narrative: Narrative: 79yo male patient in home health contacted facility to inform pt had died at outside facility on 1/8/22. See info below about pt's death from provider's chart noted dated 1/10/22 which came from non-facility medical record: "Date of Service: 12/26/2021-1/8/2022 Name of Facility: Inpatient reason for hospitalization pleural effusion, septic shock, hospital acquired pneumonia, pleux catherer placed 12/28/2021, continued antibiotics withotu improvement, not much drainage from catheter, persistent hypotension treated albumin, midrodrine, phenylephrine drip for days, could not eat or tolerate tube feeds egd/peg exchanee 1/3/2022 unfortunately multisystem organ failure, despite maximal resuscitative efforts began bradycardia arrhythmias, family elected to make him dnr comfort care, passed peacefully with family and several hospital staff, cause of death refractory cardiogenic shock 1/8/2022 8:46am "Pt had received covid vaccines from non-facility site on 2/9/21 & 3/10/21. Likely pt's death is not related to covid vaccines given pt's advanced age, information about pt's death provided, and long length of time between death & date of vaccine administrations.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Grief reaction, Hypothyroidism
Clinical narrative: Narrative:  75yo male patient died at home on 1/4/2021,cause of death unknown. See pt's problem list below: PROBLEM LAST MOD PROVIDER Prolonged grief disorder (SCT 723914003) 12/21/2021 (ICD-10-CM F43.20) Hypothyroidism (SCT 40930008) (ICD-10-CM E03.9) 11/02/2021 11/21 Depressive disorder (SCT 35489007) (ICD-10-CM 06/28/2021 F32.9) Thrombocytopenia (SCT 302215000) (ICD-10-CM 05/27/2021 D69.6) MR - Mitral regurgitation (SCT 48724000) 05/21/2021 (ICD-10-CM I34.0) Mod/severe per ECHO 05/21 TR - Tricuspid regurgitation (SCT 111287006) 05/21/2021 (ICD-10-CM I07.1) Mod/severe per ECHO 05/21 Diastolic dysfunction (SCT 3545003) (ICD-10-CM 05/21/2021 R69.) Grade III per ECHO 12/19, not mentioned per ECHO 05/21 Tubular adenoma of colon (SCT 444898006) 05/21/2021 (ICD-10-CM D12.6) C-scope 10/22/19: cecum , asc, hep flexure, disc Atrial fibrillation (SCT 49436004) (ICD-10-CM 05/21/2021 I48.91) 1. S/p pacemaker and AICD 2. Fail cardioversion 08/13/19 Chronic systolic heart failure (SCT 441481004) 05/21/2021 (ICD-10-CM I50.22) EF 35 5 and asynchronous LV motion per ECHO 05/17/21 Full care by hospice (SCT 170935008) (ICD-10-CM 05/21/2021 R69.), Onset 12/19/2019 1. Heart Failure 2. ICD was deactivated upon admission to Hospice and reactivated after discharge from Hospice on 10/16/20 cardiology clinic visit Seen by palliative care service (SCT 441874000) 05/21/2021 (ICD-10-CM Z51.5) Admitted and later discharged from Hospice care Arrested development following protein-calorie 11/24/2015 malnutrition (SCT 74257000) (ICD-10-CM Z43.1) Gastritis (SCT 4556007) (ICD-10-CM K29.70) 05/21/2021 EGD 10/19, mild (ICD-10-CM I47.2); Ventricular tachycardia 12/04/2015 (SNOMED CT 25569003) Pulmonary embolism (SCT 59282003) (ICD-10-CM 05/21/2021 I26.99) 10/12 R subsegmental artery (ICD-9-CM 306.9); Somatization (ICD-9-CM 306.9) 10/13/2012 (ICD-10-CM I25.119); Coronary artery disease 05/21/2021 (SNOMED CT 53741008) S/p 4v CABG 2015 (ICD-10-CM I10.); Benign essential hypertension 12/09/2015 (SNOMED CT 1201005) (ICD-10-CM I42.9); Cardiomyopathy (SNOMED CT 05/21/2021 85898001) EF 35% ECHO 05/17/21 (ICD-10-CM K21.9); Gastroesophageal reflux 12/09/2015 disease without esophagitis (SNOMED CT 266435005) Pt had received covid vaccines on 5/19/21 & 7/8/21. Likely pt's death is not related to covid vaccines given pt's advanced age, comorbidies, and long length of time between death & date of vaccine administrations.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthma, Brain fog, Dizziness, Dyspnoea
Clinical narrative: Developed asthma Difficulty breathing Constant flow of mucus down throat Glands in throat periodically swell to a concerning level Fatigue Brain Fog  Memory Loss Dizziness/Light headedness
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Secretion discharge
Clinical narrative: Developed asthma Difficulty breathing Constant flow of mucus down throat Glands in throat periodically swell to a concerning level Fatigue Brain Fog  Memory Loss Dizziness/Light headedness
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HPV9, PNC13, RV5
Symptoms: Restlessness, Wrong product administered
Clinical narrative: Patient was given a HPV instead of Hep B. Mom was called 2/2/22 baby did not have any side effects. Mom called 2/3/22 baby was restless all night.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Chest X-ray, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: Second Pfizer Vaccine 1/13/21  Developed pericarditis - 01/24/21 .  Had sudden onset of acute chest pain and shortness of breath. Transported by EMS to Meriter ER.   Had abnormal ECG,  low oxygen sats..  Evaluated by Cardiology.  Admitted to  observation Started on colchicine.   FYI -  Had influenza vaccine on  11/18/21.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Oxygen saturation decreased, Pericarditis, Specialist consultation
Clinical narrative: Second Pfizer Vaccine 1/13/21  Developed pericarditis - 01/24/21 .  Had sudden onset of acute chest pain and shortness of breath. Transported by EMS to Meriter ER.   Had abnormal ECG,  low oxygen sats..  Evaluated by Cardiology.  Admitted to  observation Started on colchicine.   FYI -  Had influenza vaccine on  11/18/21.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Acute myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocarditis) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Acute myocarditis) to be related.    Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  Company Comment: This is a literature case concerning a 28-year-old male patient with no reported medical history, who experienced the serious expected AESI event of myocarditis. The event occurred 3 days after the unknown dose of the mRNA-1273 vaccine. The event was assessed as related to the product administration per temporal association. The rechallenge was not applicable, as the vaccination dose number was unknown at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.; Sender's Comments: This is a literature case concerning a 28-year-old male patient with no reported medical history, who experienced the serious expected AESI event of myocarditis. The event occurred 3 days after the unknown dose of the mRNA-1273 vaccine. The event was assessed as related to the product administration per temporal association. The rechallenge was not applicable, as the vaccination dose number was unknown at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Chest pain; Shortness of breath; Heart palpitations; Stiff neck; Headaches; Brain fog; Fatigues; Joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jun2021 16:00 (Lot number: EW0217) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: yes. Concomitant medication(s) included: ZOVIA taken for contraception.  The following information was reported: CHEST PAIN (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Chest pain"; DYSPNOEA (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Shortness of breath"; PALPITATIONS (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Heart palpitations"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Stiff neck"; HEADACHE (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Headaches"; FEELING ABNORMAL (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Brain fog"; FATIGUE (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Fatigues"; ARTHRALGIA (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Joint pain". The events "chest pain", "shortness of breath", "heart palpitations", "stiff neck", "headaches", "brain fog", "fatigues" and "joint pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, palpitations, musculoskeletal stiffness, headache, feeling abnormal, fatigue, arthralgia  Additional Information: Facility type for vaccine is Pharmacy or Drug Store. No other vaccine in four weeks. Ae resulted in: Doctor or other healthcare professional office/clinic visit. Ae treatment: muscle relaxer and steroid. Patient tested for covid post vaccination. Patient had No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Palpitations, Polymerase chain reaction
Clinical narrative: Chest pain; Shortness of breath; Heart palpitations; Stiff neck; Headaches; Brain fog; Fatigues; Joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jun2021 16:00 (Lot number: EW0217) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: yes. Concomitant medication(s) included: ZOVIA taken for contraception.  The following information was reported: CHEST PAIN (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Chest pain"; DYSPNOEA (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Shortness of breath"; PALPITATIONS (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Heart palpitations"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Stiff neck"; HEADACHE (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Headaches"; FEELING ABNORMAL (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Brain fog"; FATIGUE (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Fatigues"; ARTHRALGIA (non-serious) with onset 26Jun2021, outcome "not recovered", described as "Joint pain". The events "chest pain", "shortness of breath", "heart palpitations", "stiff neck", "headaches", "brain fog", "fatigues" and "joint pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, palpitations, musculoskeletal stiffness, headache, feeling abnormal, fatigue, arthralgia  Additional Information: Facility type for vaccine is Pharmacy or Drug Store. No other vaccine in four weeks. Ae resulted in: Doctor or other healthcare professional office/clinic visit. Ae treatment: muscle relaxer and steroid. Patient tested for covid post vaccination. Patient had No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Muscle atrophy, Nerve injury, Pain
Clinical narrative: Severe burning the second the needle was inserted into injection site, nerve damage, severe joint pain in arms and shoulders. Muscle mass is decreasing. Pain is constant.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Fatigue, Headache, Limb discomfort
Clinical narrative: Chest pain with deep breath; Nausea; Head ache; Arm discomfort; Fatigue; Cough; This is a spontaneous report received from contactable Nurse (Other HCP).  A 34-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Aug2021 15:00 (Lot number: EW01706) at the age of 33 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 17Aug2021 22:00, outcome "not recovered", described as "Chest pain with deep breath"; NAUSEA (non-serious) with onset 17Aug2021 22:00, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 17Aug2021 22:00, outcome "not recovered", described as "Head ache"; LIMB DISCOMFORT (non-serious) with onset 17Aug2021 22:00, outcome "not recovered", described as "Arm discomfort"; FATIGUE (non-serious) with onset 17Aug2021 22:00, outcome "not recovered", described as "Fatigue"; COUGH (non-serious) with onset 17Aug2021 22:00, outcome "not recovered", described as "Cough". The events "chest pain with deep breath", "nausea", "headache", "arm discomfort", "fatigue" and "cough" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chest pain, nausea, headache, limb discomfort, fatigue, cough.  Additional Information: Facility where the most recent COVID-19 vaccine administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient did not receive any other medication within 2 weeks of vaccination. Patient received 0.3ml of vaccine non reconstituted. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (nasal swab) with negative result. The reported known Allergies were NKA.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: Chest pain with deep breath; Nausea; Head ache; Arm discomfort; Fatigue; Cough; This is a spontaneous report received from contactable Nurse (Other HCP).  A 34-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Aug2021 15:00 (Lot number: EW01706) at the age of 33 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 17Aug2021 22:00, outcome "not recovered", described as "Chest pain with deep breath"; NAUSEA (non-serious) with onset 17Aug2021 22:00, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 17Aug2021 22:00, outcome "not recovered", described as "Head ache"; LIMB DISCOMFORT (non-serious) with onset 17Aug2021 22:00, outcome "not recovered", described as "Arm discomfort"; FATIGUE (non-serious) with onset 17Aug2021 22:00, outcome "not recovered", described as "Fatigue"; COUGH (non-serious) with onset 17Aug2021 22:00, outcome "not recovered", described as "Cough". The events "chest pain with deep breath", "nausea", "headache", "arm discomfort", "fatigue" and "cough" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chest pain, nausea, headache, limb discomfort, fatigue, cough.  Additional Information: Facility where the most recent COVID-19 vaccine administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient did not receive any other medication within 2 weeks of vaccination. Patient received 0.3ml of vaccine non reconstituted. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (nasal swab) with negative result. The reported known Allergies were NKA.   Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Burning rash all over back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 13:00 (Lot number: Fc3182) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 21Aug2021 20:00, outcome "unknown", described as "Burning rash all over back". Therapeutic measures were not taken as a result of rash.  Additional information: The patient reported about COVID-19 Vaccine. The patient occupation reported as none of the above. The patient was not received other vaccine within four weeks. The patient was not received other medications in two weeks. Prior vaccination, the patient was not experienced COVID-19. Post vaccination, the patient was not tested for COVID-19. The patient was not had any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site rash
Clinical narrative: Vertical tracking bruise appox 2 inches; bilateral reddened rashes to the left and right of the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 10:00 (Lot number: EW0172) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Exercise induced asthma" (unspecified if ongoing), notes: Other medical history: Exercise induced asthma. Concomitant medication(s) included: NUVARING; SPIRONOLACTONE; VIT D3. Vaccination history included: Bnt162b2 (Lot number: EW0170, Administration time: 10:00 AM, Dose number: 1, Vaccine location: Right arm), administration date: 26Jul2021, when the patient was 35 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 17Aug2021 17:00, outcome "recovering", described as "Vertical tracking bruise appox 2 inches"; VACCINATION SITE RASH (non-serious) with onset 17Aug2021 17:00, outcome "recovering", described as "bilateral reddened rashes to the left and right of the injection site". Therapeutic measures were not taken as a result of vaccination site bruising, vaccination site rash.  Additional information: Vertical tracking bruise approx. 2 inches, bilateral reddened rashes to the left and right of the injection site.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Nasal oedema, Pain in extremity, Rash erythematous
Clinical narrative: nose swelled up some; pronounced swelling of my upper lip/my lower lip; lot of soreness in the arm; itchy red patches in various places on my body, including my left wrist; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 14:30 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D3; CALCIUM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Aug2021 17:00, outcome "recovering", described as "lot of soreness in the arm"; LIP SWELLING (non-serious) with onset 16Aug2021 17:00, outcome "recovering", described as "pronounced swelling of my upper lip/my lower lip"; NASAL OEDEMA (non-serious) with onset 23Aug2021 17:00, outcome "recovering", described as "nose swelled up some"; RASH ERYTHEMATOUS (non-serious) with onset Aug2021, outcome "recovering", described as "itchy red patches in various places on my body, including my left wrist". Therapeutic measures were not taken as a result of pain in extremity, lip swelling, nasal oedema, rash erythematous.  Additional information: The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. The patient received Vitamin D3 and calcium within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On the 12th and 13th, the patient had a lot of soreness in the arm. On the 16th, the patient experienced pronounced swelling of his upper lip. On the 19th-20th, he experienced pronounced swelling of his lower lip. And on the 23rd, the left side of his nose swelled up some, but not pronounced. Between these incidents, the patient also experienced itchy red patches in various places on his body, including his left wrist. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out in a minor rash on face, hear, arms, legs and back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 13:15 (Lot number: EW0183) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Bypass" (unspecified if ongoing); "Dialysis (peritoneal dialysis)" (unspecified if ongoing); "Congestive Heart Failure" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; ELIQUIS; ATORVASTATIN; CALCIUM ACETATE. Past drug history included: Zantac, reaction(s): "Allergies: Zantac", notes: Known allergy Zantac. The following information was reported: RASH (non-serious) with onset 23Aug2021 17:30, outcome "not recovered", described as "Broke out in a minor rash on face, hear, arms, legs and back". The event "broke out in a minor rash on face, hear, arms, legs and back" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of rash.  Additional information: Facility type Vaccine was Doctor's office/urgent care. Patient had no Covid prior vaccination, did not receive any other vaccines in four weeks, had not Covid tested post vaccination. Patient received Allopurinol, Eliquis, Atorvastatin, Calcium Acetat within 2 weeks of vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Palpitations, Rash
Clinical narrative: Upper body rash; pounding heart beat - fast and hard; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 10:30 (Lot number: FA7488) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: MOBIC. The following information was reported: RASH (non-serious) with onset 21Aug2021 15:30, outcome "recovered with sequelae", described as "Upper body rash"; PALPITATIONS (non-serious) with onset 21Aug2021 15:30, outcome "recovered with sequelae", described as "pounding heart beat - fast and hard". The events "upper body rash" and "pounding heart beat - fast and hard" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, palpitations.  Additional Information: The patient had not received any other vaccine in four weeks. The patient had no COVID prior vaccination and had not tested post vaccination. AE treatment with EKG, holter monitor requested  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hyperaesthesia
Clinical narrative: all the joints in my hands hurt/ached were sensitive to touch; all the joints in my hands hurt/ached were sensitive to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 14:00 (Lot number: FC3180) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: MONOLAURIN [GLYCERINE MONOLAURATE]; VITAMIN D [COLECALCIFEROL]; OMEGA 3 NATURAL. The following information was reported: ARTHRALGIA (non-serious), HYPERAESTHESIA (non-serious), outcome "unknown" and all described as "all the joints in my hands hurt/ached were sensitive to touch". Therapeutic measures were not taken as a result of arthralgia, hyperaesthesia.  Clinical information included: All the joints in my hands hurt/ached were sensitive to touch. It would get better then come back. This started a few days after the shot and continued off and on so Walgreens advised waiting on a second dose and to report this.  Additional information: The patient did not received any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not received any treatment. other medications in two weeks: multi.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed hives to bilateral arms, legs, chest and back; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Aug2021 18:00 (Lot number: FC3180) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN; ZYRTEC R. The following information was reported: URTICARIA (non-serious) with onset 25Aug2021 20:00, outcome "recovering", described as "Developed hives to bilateral arms, legs, chest and back". Therapeutic measures were not taken as a result of urticaria.  Additional Information: Patient hadn't taken other vaccine within four weeks. Patient had no Covid prior to vaccination and had not tested positive post vaccination. Patient had no allergies.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against and then tested positive for COVID19
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: General symptom
Clinical narrative: symptom onset 12/23/2021
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Hot flush, Hyperhidrosis, Mechanical urticaria, Metabolic function test
Clinical narrative: An itchy scalp/Itchiness on back; She has clusters of hives everywhere; Acid reflux; Anywhere she scratched on her body it turned red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (An itchy scalp/Itchiness on back), URTICARIA (She has clusters of hives everywhere), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and ERYTHEMA (Anywhere she scratched on her body it turned red) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2022, the patient experienced PRURITUS (An itchy scalp/Itchiness on back), URTICARIA (She has clusters of hives everywhere), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and ERYTHEMA (Anywhere she scratched on her body it turned red). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (An itchy scalp/Itchiness on back), URTICARIA (She has clusters of hives everywhere), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and ERYTHEMA (Anywhere she scratched on her body it turned red) outcome was unknown.            Concomitant product use was not provided by the reporter.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: An itchy scalp/Itchiness on back; She has clusters of hives everywhere; Acid reflux; Anywhere she scratched on her body it turned red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (An itchy scalp/Itchiness on back), URTICARIA (She has clusters of hives everywhere), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and ERYTHEMA (Anywhere she scratched on her body it turned red) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2022, the patient experienced PRURITUS (An itchy scalp/Itchiness on back), URTICARIA (She has clusters of hives everywhere), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and ERYTHEMA (Anywhere she scratched on her body it turned red). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (An itchy scalp/Itchiness on back), URTICARIA (She has clusters of hives everywhere), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and ERYTHEMA (Anywhere she scratched on her body it turned red) outcome was unknown.            Concomitant product use was not provided by the reporter.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Gastrooesophageal reflux disease, Pruritus, Urticaria
Clinical narrative: An itchy scalp/Itchiness on back; She has clusters of hives everywhere; Acid reflux; Anywhere she scratched on her body it turned red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (An itchy scalp/Itchiness on back), URTICARIA (She has clusters of hives everywhere), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and ERYTHEMA (Anywhere she scratched on her body it turned red) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2022, the patient experienced PRURITUS (An itchy scalp/Itchiness on back), URTICARIA (She has clusters of hives everywhere), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and ERYTHEMA (Anywhere she scratched on her body it turned red). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (An itchy scalp/Itchiness on back), URTICARIA (She has clusters of hives everywhere), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and ERYTHEMA (Anywhere she scratched on her body it turned red) outcome was unknown.            Concomitant product use was not provided by the reporter.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (urticaria) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced URTICARIA (urticaria) (seriousness criterion medically significant). At the time of the report, URTICARIA (urticaria) had not resolved.            No concomitant drug information was provided. No treatment drug information was provided.  Company comment: This case concerns a 32-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of Urticaria. The event occurred at an unknown interval after the booster dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after the booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 32-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of Urticaria. The event occurred at an unknown interval after the booster dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after the booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (urticaria) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced URTICARIA (urticaria) (seriousness criterion medically significant). At the time of the report, URTICARIA (urticaria) had not resolved.            No concomitant drug information was provided. No treatment drug information was provided.  Company comment: This case concerns a 32-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of Urticaria. The event occurred at an unknown interval after the booster dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after the booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 32-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of Urticaria. The event occurred at an unknown interval after the booster dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after the booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Alphavirus test, Back pain, Biopsy bone abnormal, Bone marrow necrosis, Dengue virus test
Clinical narrative: Multi-system inflammatory process - started the day after the shot with muscle pain, chest pain, back pain refractory to PPI, ibuprofen.  Seen by PCP, rheumatology, GI, and hem/onc  Elevations in ESR, CRP, Ferritin, LDH, AlkPhos, and ALT.  Broad workup for autoimmune conditions, all of which were negative.  Incidental finding of H Pylori gastritis.  Symptoms responded to steroids, labs seemed to improve as well.  When steroids were decreased, symptoms reoccured.  When steroids decreased in late January symptoms returned and were accompanied by marked drop in platelets (nadir = 10 on 1/29), which improved rapidly once steroids restarted.  Treatment ongoing and patient remains hospitalized as of 2/4/22
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Electromyogram normal, HIV test negative, Immunoglobulin therapy, Laboratory test normal, Myalgia
Clinical narrative: Multi-system inflammatory process - started the day after the shot with muscle pain, chest pain, back pain refractory to PPI, ibuprofen.  Seen by PCP, rheumatology, GI, and hem/onc  Elevations in ESR, CRP, Ferritin, LDH, AlkPhos, and ALT.  Broad workup for autoimmune conditions, all of which were negative.  Incidental finding of H Pylori gastritis.  Symptoms responded to steroids, labs seemed to improve as well.  When steroids were decreased, symptoms reoccured.  When steroids decreased in late January symptoms returned and were accompanied by marked drop in platelets (nadir = 10 on 1/29), which improved rapidly once steroids restarted.  Treatment ongoing and patient remains hospitalized as of 2/4/22
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Oral mucosal eruption, Petechiae, Platelet count decreased, Rash, Smear test
Clinical narrative: Multi-system inflammatory process - started the day after the shot with muscle pain, chest pain, back pain refractory to PPI, ibuprofen.  Seen by PCP, rheumatology, GI, and hem/onc  Elevations in ESR, CRP, Ferritin, LDH, AlkPhos, and ALT.  Broad workup for autoimmune conditions, all of which were negative.  Incidental finding of H Pylori gastritis.  Symptoms responded to steroids, labs seemed to improve as well.  When steroids were decreased, symptoms reoccured.  When steroids decreased in late January symptoms returned and were accompanied by marked drop in platelets (nadir = 10 on 1/29), which improved rapidly once steroids restarted.  Treatment ongoing and patient remains hospitalized as of 2/4/22
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Back pain, Blood alkaline phosphatase increased, Blood lactate dehydrogenase increased, C-reactive protein increased
Clinical narrative: Multi-system inflammatory process - started the day after the shot with muscle pain, chest pain, back pain refractory to PPI, ibuprofen.  Seen by PCP, rheumatology, GI, and hem/onc  Elevations in ESR, CRP, Ferritin, LDH, AlkPhos, and ALT.  Broad workup for autoimmune conditions, all of which were negative.  Incidental finding of H Pylori gastritis.  Symptoms responded to steroids, labs seemed to improve as well.  When steroids were decreased, symptoms reoccured.  When steroids decreased in late January symptoms returned and were accompanied by marked drop in platelets (nadir = 10 on 1/29), which improved rapidly once steroids restarted.  Treatment ongoing and patient remains hospitalized as of 2/4/22
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Helicobacter infection, Helicobacter test positive, Immunology test normal, Multisystem inflammatory syndrome
Clinical narrative: Multi-system inflammatory process - started the day after the shot with muscle pain, chest pain, back pain refractory to PPI, ibuprofen.  Seen by PCP, rheumatology, GI, and hem/onc  Elevations in ESR, CRP, Ferritin, LDH, AlkPhos, and ALT.  Broad workup for autoimmune conditions, all of which were negative.  Incidental finding of H Pylori gastritis.  Symptoms responded to steroids, labs seemed to improve as well.  When steroids were decreased, symptoms reoccured.  When steroids decreased in late January symptoms returned and were accompanied by marked drop in platelets (nadir = 10 on 1/29), which improved rapidly once steroids restarted.  Treatment ongoing and patient remains hospitalized as of 2/4/22
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Platelet count decreased, Red blood cell sedimentation rate increased, Serum ferritin increased
Clinical narrative: Multi-system inflammatory process - started the day after the shot with muscle pain, chest pain, back pain refractory to PPI, ibuprofen.  Seen by PCP, rheumatology, GI, and hem/onc  Elevations in ESR, CRP, Ferritin, LDH, AlkPhos, and ALT.  Broad workup for autoimmune conditions, all of which were negative.  Incidental finding of H Pylori gastritis.  Symptoms responded to steroids, labs seemed to improve as well.  When steroids were decreased, symptoms reoccured.  When steroids decreased in late January symptoms returned and were accompanied by marked drop in platelets (nadir = 10 on 1/29), which improved rapidly once steroids restarted.  Treatment ongoing and patient remains hospitalized as of 2/4/22