chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: hearing loss in right ear; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 09Nov2021 12:00 (Lot number: FH8028) at the age of 42 years as DOSE 1, SINGLE for COVID-19 immunisation. The patient received second dose of BNT162B2 (lot number: 330308D) in right arm on 30Nov2021 at 12:00 pm at single dose for COVID-19 immunisation. The patient had no relevant medical history. No COVID prior vaccination, no COVID tested post vaccination, no known allergies, no other vaccine in four weeks. There were no concomitant medications. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 09Nov2021 13:00, outcome "not recovered", described as "hearing loss in right ear". Therapeutic measures were not taken as a result of deafness unilateral.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Dysmenorrhoea, Heavy menstrual bleeding, Immunisation
Clinical narrative: heavy heavy bleeding which is atypical; my monthly period came with the worst cramps of my life; Bed bound for 24 hours with excessive bleeding; booster; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 29Nov2021 (Batch/Lot number: unknown) at the age of 32 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, no COVID tested post vaccination. Vaccination history included: BNT162B2 (dose 2, location of injection: arm left), administration date: 29Apr2021, when the patient was 32 years old, for COVID-19 immunisation; BNT162B2 (dose 1, location of injection: arm left), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Nov2021, outcome "unknown", described as "booster"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 08Dec2021, outcome "recovering", described as "heavy heavy bleeding which is atypical"; DYSMENORRHOEA (non-serious) with onset 08Dec2021, outcome "recovering", described as "my monthly period came with the worst cramps of my life"; BEDRIDDEN (non-serious) with onset 08Dec2021, outcome "recovering", described as "Bed bound for 24 hours with excessive bleeding". The patient stated that she had been having extreme menstrual cycle symptoms. Especially after the booster. She is always exactly the same month to month and got her booster on 29Nov2021 and period 08Dec2021 for 24 hours with excessive bleeding. Therapeutic measures were not taken as a result of heavy menstrual bleeding, dysmenorrhoea, bedridden.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Chills, Fatigue, Headache
Clinical narrative: severe arm pain; Fever; moderate joint/muscle pain; moderate joint/muscle pain; chills; headache; fatigue; intermittent burning in arm that vaccine was given; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 15:45 (Lot number: FJ8757) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tramadol, reaction(s): "Known allergies: Tramadol and phenergan"; Phenergan, reaction(s): "Known allergies: Tramadol and phenergan". Vaccination history included: Bnt162b2 (Dose 1, lot number: EN6206, administration time: 09:00 AM, location: Left arm), administration date: 09Mar2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, lot number: ER8730, administration time: 09:00 AM, location: Left arm), administration date: 30Mar2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 15:45, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "severe arm pain"; PYREXIA (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "Fever"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 07Dec2021 20:00, outcome "not recovered" and all described as "moderate joint/muscle pain"; CHILLS (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "headache"; FATIGUE (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "fatigue"; BURNING SENSATION (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "intermittent burning in arm that vaccine was given". Therapeutic measures were not taken as a result of pain in extremity, pyrexia, arthralgia, myalgia, chills, headache, fatigue, burning sensation. No Covid prior vaccination. No Covid tested post vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: severe arm pain; Fever; moderate joint/muscle pain; moderate joint/muscle pain; chills; headache; fatigue; intermittent burning in arm that vaccine was given; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 15:45 (Lot number: FJ8757) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tramadol, reaction(s): "Known allergies: Tramadol and phenergan"; Phenergan, reaction(s): "Known allergies: Tramadol and phenergan". Vaccination history included: Bnt162b2 (Dose 1, lot number: EN6206, administration time: 09:00 AM, location: Left arm), administration date: 09Mar2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, lot number: ER8730, administration time: 09:00 AM, location: Left arm), administration date: 30Mar2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 15:45, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "severe arm pain"; PYREXIA (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "Fever"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 07Dec2021 20:00, outcome "not recovered" and all described as "moderate joint/muscle pain"; CHILLS (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "headache"; FATIGUE (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "fatigue"; BURNING SENSATION (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "intermittent burning in arm that vaccine was given". Therapeutic measures were not taken as a result of pain in extremity, pyrexia, arthralgia, myalgia, chills, headache, fatigue, burning sensation. No Covid prior vaccination. No Covid tested post vaccination.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster / Oral Shingles reactivation; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: Er87333) at the age of 32 years as dose 2, single for covid-19 immunisation. No other vaccine in four weeks. Relevant medical history included: "herpes zoster (non-oral)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, lot number: EN6210), administration date: 10Mar2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 07May2021, outcome "recovered with sequelae", described as "Herpes Zoster / Oral Shingles reactivation". The event "herpes zoster / oral shingles reactivation" was evaluated at the physician office visit. Therapeutic measures were taken as a result of herpes zoster.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Herpes zoster with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cough, Productive cough, Pyrexia
Clinical narrative: Fever as high as 102.4; cough; spitting of phlegm to clear lungs; Runny nose; Grogginess; aching knees; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: PYREXIA (non-serious), outcome "unknown", described as "Fever as high as 102.4"; COUGH (non-serious), outcome "unknown", described as "cough"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "spitting of phlegm to clear lungs"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; SOMNOLENCE (non-serious), outcome "unknown", described as "Grogginess"; ARTHRALGIA (non-serious), outcome "unknown", described as "aching knees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient had cough, spitting of phlegm to clear lungs, runny nose & grogginess. Patient had a fever lasting 62 hours (uses Tylenol sporadically to break fever) fever got as high as 102.4 & aching knees. Phlegm that drains into lungs while sleeping. Must sleep sitting up partially.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea, Somnolence
Clinical narrative: Fever as high as 102.4; cough; spitting of phlegm to clear lungs; Runny nose; Grogginess; aching knees; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: PYREXIA (non-serious), outcome "unknown", described as "Fever as high as 102.4"; COUGH (non-serious), outcome "unknown", described as "cough"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "spitting of phlegm to clear lungs"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; SOMNOLENCE (non-serious), outcome "unknown", described as "Grogginess"; ARTHRALGIA (non-serious), outcome "unknown", described as "aching knees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient had cough, spitting of phlegm to clear lungs, runny nose & grogginess. Patient had a fever lasting 62 hours (uses Tylenol sporadically to break fever) fever got as high as 102.4 & aching knees. Phlegm that drains into lungs while sleeping. Must sleep sitting up partially.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Immunisation
Clinical narrative: Blood in urine 36 hours after vaccination; dose number=3; 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 right, administration date 07Dec2021 14:15 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was none. No Covid prior vaccination. No Covid tested post vaccination. No Known allergies. No other vaccine in four weeks. Concomitant medication(s) included: ALEVE; ESTRADIOL; PROGESTERONE (low dose HRT). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0183, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 15May2021, when the patient was 54 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0171, Location of injection: Arm Right, Vaccine Administration Time: 01:15 PM), administration date: 24Apr2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 07Dec2021, outcome "unknown", described as "dose number=3"; BLOOD URINE PRESENT (medically significant) with onset 09Dec2021 07:00, outcome "unknown", described as "Blood in urine 36 hours after vaccination". Therapeutic measures were not taken as a result of blood urine present.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Dyspnoea, Echocardiogram, Electrocardiogram, Fatigue
Clinical narrative: Rapid resting heart rate (130-250); shortness of breath; sore throat; fever; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 17:00 (Lot number: FH8028) at the age of 13 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "low iron and low vitamin d" (unspecified if ongoing), notes: Other medical history: low iron and low vitamin d; "low iron and low vitamin d" (unspecified if ongoing), notes: Other medical history: low iron and low vitamin d. No Known allergies. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication(s) included: MAGNESIUM; VITAMIN D [VITAMIN D NOS]; FERRASORB [ASCORBIC ACID;FERROUS BISGLYCINATE;LEVOMEFOLIC ACID;MECOBALAMIN;PYRIDOXAL PHOSPHATE]. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand name unknown: False, Prev dose lot number: FF2590, Prev dose Lot unknown: false, Prev dose administration date: 15Nov2021, Prev dose administration time: 05:00 PM, prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 15Nov2021, when the patient was 13 years old, for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (medically significant) with onset 06Dec2021 23:30, outcome "not recovered", described as "Rapid resting heart rate (130-250)"; DYSPNOEA (medically significant) with onset 06Dec2021 23:30, outcome "not recovered", described as "shortness of breath"; OROPHARYNGEAL PAIN (non-serious) with onset 06Dec2021 23:30, outcome "not recovered", described as "sore throat"; PYREXIA (non-serious) with onset 06Dec2021 23:30, outcome "not recovered", described as "fever"; FATIGUE (non-serious) with onset 06Dec2021 23:30, outcome "not recovered", described as "extreme fatigue". The events "rapid resting heart rate (130-250)", "shortness of breath", "sore throat", "fever" and "extreme fatigue" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: (unspecified date) unknown results; echocardiogram: (unspecified date) unknown results; electrocardiogram: (unspecified date) unknown results; heart rate: (unspecified date) 130-250; investigation: (unspecified date) unknown results; sars-cov-2 test (Nasal Swab): (09Dec2021) negative. Therapeutic measures were taken as a result of heart rate increased, dyspnoea, oropharyngeal pain, pyrexia, fatigue and treatment included ekg's, echocardiogram, ct angiogram, heart monitor. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care].
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Investigation, Oropharyngeal pain, Pyrexia
Clinical narrative: Rapid resting heart rate (130-250); shortness of breath; sore throat; fever; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 17:00 (Lot number: FH8028) at the age of 13 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "low iron and low vitamin d" (unspecified if ongoing), notes: Other medical history: low iron and low vitamin d; "low iron and low vitamin d" (unspecified if ongoing), notes: Other medical history: low iron and low vitamin d. No Known allergies. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication(s) included: MAGNESIUM; VITAMIN D [VITAMIN D NOS]; FERRASORB [ASCORBIC ACID;FERROUS BISGLYCINATE;LEVOMEFOLIC ACID;MECOBALAMIN;PYRIDOXAL PHOSPHATE]. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand name unknown: False, Prev dose lot number: FF2590, Prev dose Lot unknown: false, Prev dose administration date: 15Nov2021, Prev dose administration time: 05:00 PM, prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 15Nov2021, when the patient was 13 years old, for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (medically significant) with onset 06Dec2021 23:30, outcome "not recovered", described as "Rapid resting heart rate (130-250)"; DYSPNOEA (medically significant) with onset 06Dec2021 23:30, outcome "not recovered", described as "shortness of breath"; OROPHARYNGEAL PAIN (non-serious) with onset 06Dec2021 23:30, outcome "not recovered", described as "sore throat"; PYREXIA (non-serious) with onset 06Dec2021 23:30, outcome "not recovered", described as "fever"; FATIGUE (non-serious) with onset 06Dec2021 23:30, outcome "not recovered", described as "extreme fatigue". The events "rapid resting heart rate (130-250)", "shortness of breath", "sore throat", "fever" and "extreme fatigue" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: (unspecified date) unknown results; echocardiogram: (unspecified date) unknown results; electrocardiogram: (unspecified date) unknown results; heart rate: (unspecified date) 130-250; investigation: (unspecified date) unknown results; sars-cov-2 test (Nasal Swab): (09Dec2021) negative. Therapeutic measures were taken as a result of heart rate increased, dyspnoea, oropharyngeal pain, pyrexia, fatigue and treatment included ekg's, echocardiogram, ct angiogram, heart monitor. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care].
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Rapid resting heart rate (130-250); shortness of breath; sore throat; fever; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 17:00 (Lot number: FH8028) at the age of 13 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "low iron and low vitamin d" (unspecified if ongoing), notes: Other medical history: low iron and low vitamin d; "low iron and low vitamin d" (unspecified if ongoing), notes: Other medical history: low iron and low vitamin d. No Known allergies. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication(s) included: MAGNESIUM; VITAMIN D [VITAMIN D NOS]; FERRASORB [ASCORBIC ACID;FERROUS BISGLYCINATE;LEVOMEFOLIC ACID;MECOBALAMIN;PYRIDOXAL PHOSPHATE]. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand name unknown: False, Prev dose lot number: FF2590, Prev dose Lot unknown: false, Prev dose administration date: 15Nov2021, Prev dose administration time: 05:00 PM, prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 15Nov2021, when the patient was 13 years old, for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (medically significant) with onset 06Dec2021 23:30, outcome "not recovered", described as "Rapid resting heart rate (130-250)"; DYSPNOEA (medically significant) with onset 06Dec2021 23:30, outcome "not recovered", described as "shortness of breath"; OROPHARYNGEAL PAIN (non-serious) with onset 06Dec2021 23:30, outcome "not recovered", described as "sore throat"; PYREXIA (non-serious) with onset 06Dec2021 23:30, outcome "not recovered", described as "fever"; FATIGUE (non-serious) with onset 06Dec2021 23:30, outcome "not recovered", described as "extreme fatigue". The events "rapid resting heart rate (130-250)", "shortness of breath", "sore throat", "fever" and "extreme fatigue" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: (unspecified date) unknown results; echocardiogram: (unspecified date) unknown results; electrocardiogram: (unspecified date) unknown results; heart rate: (unspecified date) 130-250; investigation: (unspecified date) unknown results; sars-cov-2 test (Nasal Swab): (09Dec2021) negative. Therapeutic measures were taken as a result of heart rate increased, dyspnoea, oropharyngeal pain, pyrexia, fatigue and treatment included ekg's, echocardiogram, ct angiogram, heart monitor. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care].
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: I have started experiencing like some chest pressure a few hours ago, it''s kind of like hard for me to breathe a little bit, it feels like a little pressure in like my chest; I have started experiencing like some chest pressure a few hours ago, it''s kind of like hard for me to breathe a little bit, it feels like a little pressure in like my chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: CHEST DISCOMFORT (non-serious), DYSPNOEA (non-serious), outcome "unknown" and all described as "I have started experiencing like some chest pressure a few hours ago, it''s kind of like hard for me to breathe a little bit, it feels like a little pressure in like my chest".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She got covid; She got covid; This is a spontaneous report received from a contactable consumer from medical information team.  A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Apr2021 (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), COVID-19 (medically significant), outcome "unknown" and all described as "She got covid". Then, the patient received the second dose in Nov2021.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Immunisation, Palpitations
Clinical narrative: I have started to have palpitations and heart fluttering.; 3rd shot booster and being a reported side effect; I have started to have palpitations and heart fluttering.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 06Dec2021 17:00 (Batch/Lot number: unknown) at the age of 61 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "allergy to Trace dye" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; VIT D [COLECALCIFEROL]; KRILL OIL; VIT B COMPLEX. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. , Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 23Apr2021, when the patient was 60 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 06Apr2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: CARDIAC FLUTTER (medically significant), PALPITATIONS (non-serious) all with onset 07Dec2021, outcome "not recovered" and all described as "I have started to have palpitations and heart fluttering."; IMMUNISATION (non-serious) with onset 07Dec2021, outcome "not recovered", described as "3rd shot booster and being a reported side effect". Therapeutic measures were not taken as a result of cardiac flutter, palpitations. Clinical course: 'I have started to have palpitations and heart fluttering. This was a familiar feeling as it occurred every so often maybe once or twice, throughout adulthood. But that quickly went away. Now it has started and has been 3 days now and has continued throughout the day. As I have been willing to let it take it's course, it just dawned on me the connection to possibly a recent 3rd shot booster and being a reported side effect'. No covid prior vaccination. No covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Computerised tomogram, Ischaemic stroke, Laboratory test
Clinical narrative: ischemic stroke; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 68 year-old male patient, a former Pfizer employee, received bnt162b2 (BNT162B2), administration date 12Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 21Jan2021, when the patient was 67 years old, for Covid-19 immunization. The following information was reported: ISCHAEMIC STROKE (hospitalization) with onset 25Mar2021, outcome "recovered", described as "ischemic stroke". The event "ischemic stroke" was evaluated at the physician office visit. The patient reported that after his second dose of the purple cap Pfizer Covid-19 vaccine that he had an ischemic stroke five and a half weeks afterwards. The stroke was treated pretty rapidly and he has done fine with the recovery. Caller states that he has never had any health event before this and the cardiologist have run every test that he could but have not been able to answer what has caused him to have the ischemic stroke. He had a CAT scan and they ran a battery of tests while he was in the hospital for part of two days and one night. He has visited his cardiologist 3-4 times who has put him on apixaban (ELIQUIS) as a prevention for possible future events. He has not found out why it happened. He was told by the doctors that they did not think that the vaccine had anything to do with the stroke. They have not determined what triggered the stroke. He stated that he wanted to get a booster dose but he is nervous about that with what happened, he is hesitant and wary about getting the booster dose of the purple cap Pfizer Covid-19 vaccine and has heard that it's better to mix the Covid-19 vaccines with the booster dose and is more effective to do so. He asked if ischemic stroke is a side effect of the purple cap Pfizer Covid-19 vaccine and wanted to know what is the risk of having a stroke with the purple cap booster dose Pfizer Covid-19 vaccine. He wanted to know if one had an ischemic stroke does it increase chances to have another with booster. He stated that he is considering the booster and the cardiologist ran a titer and it was pretty low. The patient stated that the cardiologist is encouraging him to get another vaccine as his titer had dropped to 179. It has been eight months since his last dose. The patient underwent the following laboratory tests and procedures: antibody test: (2021) dropped to 179, notes: cardiologist ran a titer and it was pretty low; computerised tomogram: (2021) unknown results; laboratory test: (2021) unknown results. Therapeutic measures were taken as a result of ischaemic stroke.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diabetes mellitus, Injection site extravasation, Pain
Clinical narrative: Ache; Injection site leaking; COVID-19; Diabetes; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4087377-00 (COMPANY). A 68 year old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), intramuscular, administration date 03Dec2021 at the age of 68 years as dose 1, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as citrate free and subcutaneous (Batch/Lot number: unknown) as citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 23Aug2021, outcome "recovered" (2021), described as "COVID-19"; DIABETES MELLITUS (medically significant) with onset 2021, outcome "recovering", described as "Diabetes"; INJECTION SITE EXTRAVASATION (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "Injection site leaking"; PAIN (non-serious), outcome "recovering", described as "Ache". The action taken for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB)  The reporter's causality for the event(s) of COVID-19, medication ooze back out from shot site and aching with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of diabetes was not provided.    The lot number for (BNT162B2) was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 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.
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Immunisation, Loss of personal independence in daily activities, Nervousness, Off label use
Clinical narrative: tinnitus; They make me nervous everyday; I can't live like normal/Im not gonna live a normal life like before this vaccine; I can't focus; I did the third shot/I did the vaccine July; I did the third shot/I did the vaccine July; 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 40 year-old female patient received bnt162b2 (COMIRNATY), administration date Jul2021 (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:1), for Covid-19 Immunization; Bnt162b2 (dose:2), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset Jul2021, outcome "unknown" and all described as "I did the third shot/I did the vaccine July"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus"; NERVOUSNESS (non-serious), outcome "unknown", described as "They make me nervous everyday"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I can't live like normal/Im not gonna live a normal life like before this vaccine"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "I can't focus".  Additional information: Patient was visited neurology doctor, so he's pretty sure he checked her up her hearing everything. he said, you don't have nothing. but this reaction comes the next day when she did the third shot." Doctor gave her some 3 kind of medication. And she was doing it for a healthy life. Caller added, "that was come from the vaccine. she never heard before this problem. Her husband has the same problem. The last step today is MRI. But my neurologist professor, he's pretty sure that my brain is ok but I don't see get out, the last step is MRI. Patient was feeling sorry she did this vaccine and she would not recommend it to nobody okay. Because you see some people got the vaccine they could be disabled. So this noise could not disappear for life. If the people get disabled with the vaccine they never get back the normal life.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (21Dec2021). Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; They make me nervous everyday; I can't live like normal/Im not gonna live a normal life like before this vaccine; I can't focus; I did the third shot/I did the vaccine July; I did the third shot/I did the vaccine July; 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 40 year-old female patient received bnt162b2 (COMIRNATY), administration date Jul2021 (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:1), for Covid-19 Immunization; Bnt162b2 (dose:2), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset Jul2021, outcome "unknown" and all described as "I did the third shot/I did the vaccine July"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus"; NERVOUSNESS (non-serious), outcome "unknown", described as "They make me nervous everyday"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I can't live like normal/Im not gonna live a normal life like before this vaccine"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "I can't focus".  Additional information: Patient was visited neurology doctor, so he's pretty sure he checked her up her hearing everything. he said, you don't have nothing. but this reaction comes the next day when she did the third shot." Doctor gave her some 3 kind of medication. And she was doing it for a healthy life. Caller added, "that was come from the vaccine. she never heard before this problem. Her husband has the same problem. The last step today is MRI. But my neurologist professor, he's pretty sure that my brain is ok but I don't see get out, the last step is MRI. Patient was feeling sorry she did this vaccine and she would not recommend it to nobody okay. Because you see some people got the vaccine they could be disabled. So this noise could not disappear for life. If the people get disabled with the vaccine they never get back the normal life.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (21Dec2021). Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got Corona virus disease; I got Corona virus disease; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (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), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "I got Corona virus disease over the holidays". The patient wanted to know when he can get his booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Thrombosis
Clinical narrative: experienced a blood clot in his left leg; received the 3rd dose Pfizer BioNTech Covid vaccine; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 64-year-old male patient received bnt162b2 (COMIRNATY) (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: Covid-19 vaccine (Dose number: 2, MANUFACTURER: UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose number: 1, MANUFACTURER: UNKNOWN), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "experienced a blood clot in his left leg"; IMMUNISATION (medically significant), outcome "unknown", described as "received the 3rd dose Pfizer BioNTech Covid vaccine". Therapeutic measures were taken as a result of thrombosis. The patient had been placed on anticoagulants by a vascular surgeon. The lot number for bnt162b2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Headache, Pain, Weight, Weight increased
Clinical narrative: Crohn's disease aggravated; Weight gain; Pain; Headache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4188468-00 (AbbVie).  A 24 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1146119) at cf for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WEIGHT INCREASED (non-serious), outcome "unknown", described as "Weight gain"; CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's disease aggravated"; PAIN (non-serious), outcome "unknown", described as "Pain"; HEADACHE (non-serious), outcome "recovered", described as "Headache". The patient underwent the following laboratory tests and procedures: weight: gained. The action taken for adalimumab was unknown.  Causality Assessments: Headache assessed related and weight gain, crohn's disease aggravated, pain, assessed to not reported to BNT162B2. Since no determination has been received for events weight gain, crohn's disease aggravated and pain, the events are managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events weight gain, crohn's disease aggravated, pain and headache with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: blood clots in her lungs; blood clots in her lungs; Pfizer Covid 19 vaccine booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Nov2021 (two weeks ago since 10Dec2021) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), PULMONARY THROMBOSIS (medically significant), outcome "unknown" and all described as "blood clots in her lungs"; IMMUNISATION (medically significant), outcome "unknown", described as "Pfizer Covid 19 vaccine booster". The event "blood clots in her lungs" and "blood clots in her lungs" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism, pulmonary thrombosis with Eliquis blood thinner. Clinical course: The patient stated that they just got the booster and she has blood clots in her lungs; stated that they just got out of the ER last night.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Full blood count, Glycosylated haemoglobin, Hypoaesthesia, Hypoaesthesia eye
Clinical narrative: Numbness on his face and on the left eye/ my face started feeling numb; Numbness on his face and on the left eye; It's kind of like Bell's Palsy thing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Nov2021 (Lot number: FF2588) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes; "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: INVOKAMET taken for diabetes mellitus; GLIPIZIDE taken for diabetes mellitus. The following information was reported: BELL'S PALSY (medically significant) with onset Nov2021, outcome "recovering", described as "It's kind of like Bell's Palsy thing"; HYPOAESTHESIA (non-serious) with onset 25Nov2021, outcome "recovering", described as "Numbness on his face and on the left eye/ my face started feeling numb"; HYPOAESTHESIA EYE (non-serious) with onset Nov2021, outcome "recovering", described as "Numbness on his face and on the left eye". The events "it's kind of like bell's palsy thing", "numbness on his face and on the left eye/ my face started feeling numb" and "numbness on his face and on the left eye" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: full blood count: unknown result; glycosylated haemoglobin: unknown result. Therapeutic measures were taken as a result of bell's palsy, hypoaesthesia, hypoaesthesia eye. Treatment received included prednisone. Clinical course: Patient already took his first dose for the COVID vaccine on 21Nov2021 and after taking that first dose he is not sure if it's cause or the side effect comes from the vaccine because he experienced numbness on his face and on the left eye and wonder, if it's safe to take second dose on 12Dec2021. Just after the four days after first dose face started feeling numb and he was not completely positive that the Pfizer shot was what 'causing' it. He went to the doctor and they could not tell him, if that was, what cause the problem or not, it's kind of like Bell's Palsy thing and in last couple of days, patient was better."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got covid; got covid; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (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". Caller (patient) called to ask about the booster of the Pfizer COVID-19 vaccine. She stated that she received 2 doses of the vaccine last Jan2021 and Feb2021 but got COVID-19. She was advised to wait for 90 days before taking the booster shot but before the 90 days were up, she took a flu shot and got Guillain-Barre and at the time of this report she was walking in a cane. She said she wanted to travel and based on her research, the booster of the Pfizer COVID-19 vaccine had less incidence than any other boosters. She wanted to know if there was any information or reports regarding Guillain-Barre after receiving the booster shot. She stated that she wanted a document about the reports of Guillain-Barre syndrome (GBS), if there was any, to show to her doctor so she might get the booster as her doctor did not want her to receive it because she already had a history of GBS due to the flu vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.