chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope, Tremor
Clinical narrative: Fainting in the shower with white out vision; Uncontrollable shaking and convulsions; Fever of 103.3 degrees F.; Uncontrollable shaking and convulsions; Body Aches; Chills/Teeth Chattering; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 11:30 (Lot number: FF2587) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Prior to vaccination, was the patient did not diagnose with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8737, Location of injection: Arm Left, Vaccine Administration Time: 07:00 AM), administration date: 30Mar2021, when the patient was 33 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Right, Vaccine Administration Time: 07:00 AM), administration date: 09Mar2021, when the patient was 33 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021 11:30, outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Fainting in the shower with white out vision"; SEIZURE (medically significant) with onset 18Nov2021 17:00, outcome "recovered" (Nov2021), PYREXIA (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021) and all described as "Fever of 103.3 degrees F."; TREMOR (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Uncontrollable shaking and convulsions"; PAIN (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Body Aches"; CHILLS (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Chills/Teeth Chattering". The patient underwent the following laboratory tests and procedures: body temperature: (18Nov2021) 103.3 Fahrenheit, notes: 17:00. Since the vaccination, has the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Myocardial infarction, Pain in extremity, Palpitations
Clinical narrative: heart palpitations/Her heart was palpitating; felt like she was panicking; She was under stress; chest pain; tightness in her chest; she had pain in her arm that went to her chest; She was scared she was having a heart attack or something; 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 37 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Aug2021 (Lot number: FC3180) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "She was scared she was having a heart attack or something"; PALPITATIONS (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "heart palpitations/Her heart was palpitating"; PANIC REACTION (non-serious) with onset 2021, outcome "unknown", described as "felt like she was panicking"; STRESS (non-serious) with onset 2021, outcome "unknown", described as "She was under stress"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "chest pain"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "tightness in her chest"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "she had pain in her arm that went to her chest". The events "she was scared she was having a heart attack or something", "heart palpitations/her heart was palpitating" were evaluated at the physician office visit and emergency room visit. The events "chest pain" and "tightness in her chest" were evaluated at the emergency room visit. Clinical course reported as: After the first COVID vaccine, it was almost exactly a week later that she started having heart palpitations. It continued throughout the week for 2-3 weeks. She felt like she was panicking. She is a heavy person, but she still runs on the treadmill, and she still likes to workout. She was under stress. Her heart was palpitating. The palpitations have since went away, but they didn't go away until after the second dose. She also had chest pain and tightness in her chest. It was freaking her out. She was scared she was having a heart attack or something. She went to the Emergency room because she went to the pharmacist, and they said they wouldn't be comfortable giving her the next shot without seeing a doctor. She went to the clinic, and they said they couldn't help her so they told her to go to the Emergency room. The doctor there checked her heart, and told her to follow up with a regular care doctor. He said he still recommends the second COVID vaccine. So she went and got the second COVID vaccine a week later.  Follow-up attempts completed. No further information expected
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Panic reaction, Stress
Clinical narrative: heart palpitations/Her heart was palpitating; felt like she was panicking; She was under stress; chest pain; tightness in her chest; she had pain in her arm that went to her chest; She was scared she was having a heart attack or something; 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 37 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Aug2021 (Lot number: FC3180) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "She was scared she was having a heart attack or something"; PALPITATIONS (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "heart palpitations/Her heart was palpitating"; PANIC REACTION (non-serious) with onset 2021, outcome "unknown", described as "felt like she was panicking"; STRESS (non-serious) with onset 2021, outcome "unknown", described as "She was under stress"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "chest pain"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "tightness in her chest"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "she had pain in her arm that went to her chest". The events "she was scared she was having a heart attack or something", "heart palpitations/her heart was palpitating" were evaluated at the physician office visit and emergency room visit. The events "chest pain" and "tightness in her chest" were evaluated at the emergency room visit. Clinical course reported as: After the first COVID vaccine, it was almost exactly a week later that she started having heart palpitations. It continued throughout the week for 2-3 weeks. She felt like she was panicking. She is a heavy person, but she still runs on the treadmill, and she still likes to workout. She was under stress. Her heart was palpitating. The palpitations have since went away, but they didn't go away until after the second dose. She also had chest pain and tightness in her chest. It was freaking her out. She was scared she was having a heart attack or something. She went to the Emergency room because she went to the pharmacist, and they said they wouldn't be comfortable giving her the next shot without seeing a doctor. She went to the clinic, and they said they couldn't help her so they told her to go to the Emergency room. The doctor there checked her heart, and told her to follow up with a regular care doctor. He said he still recommends the second COVID vaccine. So she went and got the second COVID vaccine a week later.  Follow-up attempts completed. No further information expected
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Inappropriate schedule of product administration, Pericarditis
Clinical narrative: Inflammation around the heart; shortness of breath; chest pain; administration date=17Apr2021, Dose 2/administration date=07Apr2021, Dose 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 26 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Apr2021 (Lot number: EP6955) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot Number: ER8743, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 07Apr2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: PERICARDITIS (medically significant) with onset 14May2021, outcome "recovered", described as "Inflammation around the heart"; DYSPNOEA (non-serious) with onset 14May2021, outcome "recovered", described as "shortness of breath"; CHEST PAIN (non-serious) with onset 14May2021, outcome "recovered", described as "chest pain"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Apr2021, outcome "unknown", described as "administration date=17Apr2021, Dose 2/administration date=07Apr2021, Dose 1". The events "inflammation around the heart", "shortness of breath" and "chest pain" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pericarditis, dyspnoea, chest pain. None of allergies. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and no covid tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Delusional perception, Drowning, Immunisation, Suspected suicide
Clinical narrative: booster; delusional; drowning - could be suicide; drowning - could be suicide; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP).  An elderly male patient received bnt162b2 (Pfizer COVID-19) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1), for Covid-19 Immunization. The following information was reported: IMMUNISATION (death), outcome "fatal", described as "booster "; SUSPECTED SUICIDE (death), DROWNING (death) all with onset 19Nov2021, outcome "fatal" and all described as "drowning - could be suicide"; DELUSIONAL PERCEPTION (death), outcome "fatal", described as "delusional",the person was delusional after receiving the third vaccine shot. It does not appear that it was immediately after receiving the vaccine injection, but a few days. It was unknown if therapeutic measures were taken as a result of immunisation, suspected suicide, drowning, delusional perception. The patient date of death was 19Nov2021. The reported cause of death was suspected suicide, drowning, delusional perception. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: drowning - could be suicide; delusional; drowning - could be suicide
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Swelling face
Clinical narrative: Rash; Swelling on face and arms; Swelling on face and arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient received bnt162b2 (COMIRNATY), administration date Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset Nov2021, outcome "not recovered", described as "Rash"; SWELLING FACE (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "Swelling on face and arms". The events "rash", "swelling on face and arms" and "swelling on face and arms" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of rash, swelling face, peripheral swelling. Additional information: This report was received via a regulatory authority. The patient took antihistamines as treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Magnetic resonance imaging, Ophthalmoplegia, Ultrasound scan
Clinical narrative: Internuclear ophthalmoplegia, left eye; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 51-year-old male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Batch/Lot number: unknown) at the age of 51 years as dose 2, single for covid-19 immunisation at drug Store. Relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing); "Seafood allergy" (unspecified if ongoing); "Apple' allergy" (unspecified if ongoing), notes: Apple' allergy; "COVID-19" (unspecified if ongoing), notes: diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included: MONTELUKAST; ATORVASTATIN; LIPITOR; METFORMIN; BREO ELLIPTA; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 19Oct2021, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: OPHTHALMOPLEGIA (hospitalization, disability) with onset 18Nov2021, outcome "not recovered", described as "Internuclear ophthalmoplegia, left eye". The patient was hospitalized for ophthalmoplegia (hospitalization duration: 3 day(s)). The event "internuclear ophthalmoplegia, left eye" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: echocardiogram: unknown; magnetic resonance imaging: unknown; ultrasound scan: unknown. Therapeutic measures were taken as a result of ophthalmoplegia with Stroke workup, aspirin, ophthalmology and neurology evaluation.  Clinical Course: Patient developed Internuclear ophthalmoplegia, left eye, 9 days after the second dose which required 3 days of hospitalization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the event and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Left ventricular hypertrophy, SARS-CoV-2 test
Clinical narrative: Left ventricle hypertrophy; dyspnoea; asthma flare up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 10:00 (Lot number: FC3184) at the age of 31 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN ALLERGIC. Past drug history included: Penicillin, reaction(s): "allergy", notes: known allergies: Penicillin.  The following information was reported: LEFT VENTRICULAR HYPERTROPHY (disability) with onset 12Aug2021 04:00, outcome "not recovered", described as "Left ventricle hypertrophy"; DYSPNOEA (disability) with onset 12Aug2021 04:00, outcome "not recovered", described as "dyspnea"; CONDITION AGGRAVATED (disability) with onset 12Aug2021 04:00, outcome "not recovered", described as "asthma flare up". The events "left ventricle hypertrophy", "dyspnea" and "asthma flare up" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Aug2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of left ventricular hypertrophy, dyspnea, condition aggravated. The patient received Inhalers and steroids as treatment. Therapeutic measures were taken as a result of left ventricular hypertrophy, dyspnea, and condition aggravated.  Clinical course: The patient medical history included asthma from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Patient was not tested for Covid post vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache, Malaise, Parosmia
Clinical narrative: Headache since injection; Smelling a feet odor that is not there; some loss of taste and smell; some loss of taste and smell; overall unwell feeling; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 18:00 (Batch/Lot number: unknown) at the age of 28 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: HEADACHE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Headache since injection"; PAROSMIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Smelling a feet odor that is not there"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 18Nov2021, outcome "not recovered" and all described as "some loss of taste and smell"; MALAISE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "overall unwell feeling". Therapeutic measures were not taken as a result of headache, parosmia, ageusia, anosmia, malaise. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks and didn't receive any other medications in two weeks. Known allergies: No, other medical history: None. The vaccine was administrated in Pharmacy/drug store. Since the vaccination, the patient has not been tested for COVID-19. The events didn't result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The events were reported as non-serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Rash, Urticaria, Vaccination site pruritus
Clinical narrative: Heart Palpitations; Skin rash; hives throughout body; Itchy skin at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 (Lot number: FC3181) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Peanuts" (unspecified if ongoing), notes: known allergies: Peanuts and amoxicillin; "Eczema" (unspecified if ongoing), notes: other medical history: Eczema and asthma; "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FE3592, Location of injection: Arm Left), for COVID-19 Immunization. The following information was reported: PALPITATIONS (non-serious) with onset 07Sep2021, outcome "recovered" (2021), described as "Heart Palpitations"; RASH (non-serious) with onset 07Sep2021, outcome "recovered" (2021), described as "Skin rash"; URTICARIA (non-serious) with onset 07Sep2021, outcome "recovered" (2021), described as "hives throughout body"; VACCINATION SITE PRURITUS (non-serious) with onset 07Sep2021, outcome "recovered" (2021), described as "Itchy skin at injection site". Therapeutic measures were taken as a result of palpitations, rash, urticaria, vaccination site pruritus.  Additional information: This report is received from other HCP. Pregnancy at time of Vaccination: No. AE treatment: Benadryl. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Pruritus, Rash, Rash pruritic
Clinical narrative: Splotchy, red, and itchy raised rash under both arms and alongg side of torso; Splotchy, red, and itchy raised rash/ rash mainly on right inner thigh near groin, smaller rash on left of inner side groin; Splotchy, red, and itchy raised rash; extremely itchy and dry elbows; extremely itchy and dry elbows/ itchy and red rash on both ankles and up and down both thighs/small itchy rash on back waist; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 17:00 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ERYTHEMA (medically significant) with onset 20Oct2021, outcome "recovering", described as "Splotchy, red, and itchy raised rash under both arms and alongg side of torso"; RASH (medically significant) with onset 20Oct2021, outcome "recovering", described as "Splotchy, red, and itchy raised rash/ rash mainly on right inner thigh near groin, smaller rash on left of inner side groin"; RASH PRURITIC (medically significant) with onset 20Oct2021, outcome "recovering", described as "Splotchy, red, and itchy raised rash"; DRY SKIN (medically significant) with onset 20Oct2021, outcome "recovering", described as "extremely itchy and dry elbows"; PRURITUS (medically significant) with onset 20Oct2021, outcome "recovering", described as "extremely itchy and dry elbows/ itchy and red rash on both ankles and up and down both thighs/small itchy rash on back waist". Therapeutic measures were taken as a result of erythema, rash, rash pruritic, dry skin, pruritus. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient was not tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Erythema, Rash, Rash pruritic ,Dry skin, pruritis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees, and investigators, as appropriate.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Blood test, Bone pain, Feeling abnormal
Clinical narrative: I was paralyzed; every bone of my body hurt; every joint hurt; my entire vertebrae hurt; I was in such pain /my entire body, every bone of my body hurt, every joint hurt; I could not get out of bed; I was in terrible shape; I was so sick; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 89 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 89 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "I had a kidney stone" (unspecified if ongoing), notes: I remember I had a kidney stone past one time (History) and that is very painful. Concomitant medication(s) included: FAMOTIDINE; ALLOPURINOL; PRIMIDONE; TAMSULOSIN HYDROCHLORIDE; LANSOPRAZOLE; LEVOTHYROXINE SODIUM; SUCRALFATE. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization; Bnt162b2 (Dose:02), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; PARALYSIS (medically significant) with onset 19Nov2021, outcome "unknown", described as "I was paralyzed"; BONE PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "every bone of my body hurt"; ARTHRALGIA (non-serious) with onset 19Nov2021, outcome "unknown", described as "every joint hurt"; SPINAL PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "my entire vertebrae hurt"; PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was in such pain /my entire body, every bone of my body hurt, every joint hurt"; BEDRIDDEN (non-serious) with onset 19Nov2021, outcome "unknown", described as "I could not get out of bed"; FEELING ABNORMAL (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was in terrible shape"; ILLNESS (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was so sick". The patient underwent the following laboratory tests and procedures: blood test: unknown results. Therapeutic measures were taken as a result of immunisation, paralysis, bone pain, arthralgia, spinal pain, pain, bedridden, feeling abnormal. The patient was taking Ibuprofen along with some other pain medication (Unspecified medications) to ease the pain and still the patient was not right.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Immunisation, Pain, Paralysis, Spinal pain
Clinical narrative: I was paralyzed; every bone of my body hurt; every joint hurt; my entire vertebrae hurt; I was in such pain /my entire body, every bone of my body hurt, every joint hurt; I could not get out of bed; I was in terrible shape; I was so sick; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 89 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 89 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "I had a kidney stone" (unspecified if ongoing), notes: I remember I had a kidney stone past one time (History) and that is very painful. Concomitant medication(s) included: FAMOTIDINE; ALLOPURINOL; PRIMIDONE; TAMSULOSIN HYDROCHLORIDE; LANSOPRAZOLE; LEVOTHYROXINE SODIUM; SUCRALFATE. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization; Bnt162b2 (Dose:02), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; PARALYSIS (medically significant) with onset 19Nov2021, outcome "unknown", described as "I was paralyzed"; BONE PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "every bone of my body hurt"; ARTHRALGIA (non-serious) with onset 19Nov2021, outcome "unknown", described as "every joint hurt"; SPINAL PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "my entire vertebrae hurt"; PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was in such pain /my entire body, every bone of my body hurt, every joint hurt"; BEDRIDDEN (non-serious) with onset 19Nov2021, outcome "unknown", described as "I could not get out of bed"; FEELING ABNORMAL (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was in terrible shape"; ILLNESS (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was so sick". The patient underwent the following laboratory tests and procedures: blood test: unknown results. Therapeutic measures were taken as a result of immunisation, paralysis, bone pain, arthralgia, spinal pain, pain, bedridden, feeling abnormal. The patient was taking Ibuprofen along with some other pain medication (Unspecified medications) to ease the pain and still the patient was not right.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Contracted COVID 6 days after receiving first Dose.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 18:00 (Batch/Lot number: unknown) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 15Nov2021, outcome "recovering", described as "Contracted COVID 6 days after receiving first Dose.". The event "contracted covid 6 days after receiving first dose." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Nov2021) positive. There is no information that patient receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: joint pain; minimal aches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient in her 50's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; PAIN (non-serious), outcome "unknown", described as "minimal aches". The healthy patient was in late 50 years of age. No underlying conditions known.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got Covid; got Covid; This is a spontaneous report from a contactable consumer (patient).   A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number: unknown) as DOSE 2, SINGLE and (batch/lot number: unknown) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid". The patient reported that had both vaccines he/she got Covid again like two days before he/she supposed to get the booster shot, thought they should change the requirement on the 6 months because if had sooner he/she thought wouldn't have the Covid.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Infection; This is a spontaneous report received from a contactable reporter, Consumer, for a Pfizer sponsored program (159558). The reporter is the patient's grandmother.  An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications as the patient was on a blood thinner. The following information was reported: INFECTION (hospitalization), outcome "unknown", described as "Infection". The grandmother stated that her adult granddaughter received 1st dose of the Pfizer COVID vaccine and became ill because of an infection and was sent to a hospital.  It was closer to 6-7 months after the first dose. She would like to know if her granddaughter needed to repeat 1st dose or can she get second dose at this point.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Ventricular extrasystoles
Clinical narrative: myocarditis; PVC (premature ventricular contraction); This is a spontaneous report received from a contactable reporter (Other HCP) from medical information team.  A 6 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; VENTRICULAR EXTRASYSTOLES (medically significant), outcome "unknown", described as "PVC (premature ventricular contraction)". Child that was sent to hospital on Saturday, crushing chest pain, diagnosed with myocarditis and PVC.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate., Linked Report(s) : US-PFIZER INC-202101626263 same reporter and vaccine, different patient and AE
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Immunisation, SARS-CoV-2 test
Clinical narrative: Could not roll over, sit up or get out of bed next morning; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: 301558A) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No covid prior vaccination. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3302), administration date: 06Feb2021, when the patient was 78 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231), administration date: 16Jan2021, when the patient was 78 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (hospitalization) with onset 22Oct2021, outcome "unknown", described as "Booster"; BEDRIDDEN (hospitalization) with onset 23Oct2021, outcome "not recovered", described as "Could not roll over, sit up or get out of bed next morning". The patient was hospitalized for immunization, bedridden (start date: 23Nov2021, discharge date: 27Nov2021, hospitalization duration: 4 day(s)). The event "could not roll over, sit up or get out of bed next morning" was evaluated at the emergency room visit. 911 had to be called and was taken to ER. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Ear pain, Headache, Immunisation, Pain
Clinical narrative: got the Pfizer Booster shot; felt like I had Covid (infection); felt like I had Covid (infection); Bad Headache; Ears hurting and they kept constantly feeling like there was buzz; Ears hurting and they kept constantly feeling like there was buzz; Sore not at the site of the shot but everywhere just for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 16Nov2021; METOPROLOL. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "got the Pfizer Booster shot"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "felt like I had Covid (infection)"; HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "Bad Headache"; EAR PAIN (non-serious), TINNITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "Ears hurting and they kept constantly feeling like there was buzz"; PAIN (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Sore not at the site of the shot but everywhere just for 2 days". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19, headache, ear pain, tinnitus, pain which included patient took some Tylenol that's all she could take and drank like a big bottle of water. She drank some tea and just thought that she was going to be dead, that's the worst thing ever. Clinical course: she started out with the really bad headache and her ears were hurting and they kept constantly feeling like there was buzz in into like that. She just got hearing she can't explain it and then there was a lot of pain, all she did she just go to bed. It just felt like she had Covid (infection), she had not have it but that's how she felt after getting the shot. She was in so much pain and it was not good, it was for 2 days. She got the vaccines (first and second dose) and after that she got the Booster shot (Covid Vaccine). Afterwards, she knew it can be sore or what not at the site of the shot but everywhere but it was just for 2 days, so all once all she had on Thursday but today she was feeling ok.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Tinnitus
Clinical narrative: got the Pfizer Booster shot; felt like I had Covid (infection); felt like I had Covid (infection); Bad Headache; Ears hurting and they kept constantly feeling like there was buzz; Ears hurting and they kept constantly feeling like there was buzz; Sore not at the site of the shot but everywhere just for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 16Nov2021; METOPROLOL. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "got the Pfizer Booster shot"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "felt like I had Covid (infection)"; HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "Bad Headache"; EAR PAIN (non-serious), TINNITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "Ears hurting and they kept constantly feeling like there was buzz"; PAIN (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Sore not at the site of the shot but everywhere just for 2 days". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19, headache, ear pain, tinnitus, pain which included patient took some Tylenol that's all she could take and drank like a big bottle of water. She drank some tea and just thought that she was going to be dead, that's the worst thing ever. Clinical course: she started out with the really bad headache and her ears were hurting and they kept constantly feeling like there was buzz in into like that. She just got hearing she can't explain it and then there was a lot of pain, all she did she just go to bed. It just felt like she had Covid (infection), she had not have it but that's how she felt after getting the shot. She was in so much pain and it was not good, it was for 2 days. She got the vaccines (first and second dose) and after that she got the Booster shot (Covid Vaccine). Afterwards, she knew it can be sore or what not at the site of the shot but everywhere but it was just for 2 days, so all once all she had on Thursday but today she was feeling ok.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive Covid 19 Test; Positive Covid 19 Test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), intramuscular, administered in arm left, administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in arm left, administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Nov2021, outcome "not recovered" and all described as "Positive COVID-19 Test". The patient underwent the following laboratory tests and procedures: Nasal Swab: (18Nov2021) positive, notes: Nasal Swab; PCR: (18Nov2021) positive, notes: PCR. Therapeutic measures were not taken as a result of vaccination failure, COVID-19. Clinical course: It was reported that, patient did not receive any other vaccine in four weeks and no other medications in two weeks. She was not diagnosed with COVID-19, prior to vaccination. She was tested for COVID-19, after the vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.