chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer or other non healthcare professional. A 53 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing known allergies to Shrimp and opioids, toxicity to various agents from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced psoriatic arthritis and after the first shot had pain and swelling on an unspecified date with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Apr2021 with Nasal Swab. Therapeutic measures were taken as a result of these events with Acupuncture, chiropractic, pain meds, Humira.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Peripheral swelling, SARS-CoV-2 test, Skin disorder, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3302), via an unspecified route of administration on arm left on 06Mar2021 01:00 PM (age at vaccination: 53 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history included psoriatic arthritis (I have psoriatic arthritis) and known allergies to Shrimps and opoids. If other vaccine in four weeks and other medications in two weeks was reported as no. The patient Concomitant medications was reported as none. COVID prior vaccination was reported as no. COVID tested post vaccination was reported as yes. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on 27Mar2021 01:00 PM (at the age of 53 years) as DOSE 1, SINGLE for COVID-19 immunisation and reported that I have psoriatic arthritis and after the first shot I had pain and swelling. It was reported that he had psoriatic arthritis and after the first shot he had pain and swelling that he thought was just a bad patch, after the second he was in so much pain that got worse by the day and his feet swelled to the point where he could not put on shoes and had difficulty walking, his whole body was riddled with skin blemishes that he never had before but like the pain and swelling were extreme versions of his preexisting condition. He was in so much pain he cannot lie. He was scared. This was all because of the vaccine making his condition rage in his body. Several doctors said they have seen this sort of amplification of existing symptoms. The events resulted in Doctor or other healthcare professional office/clinic visit.The lab test included SARS-CoV-2 test(nasal swab): Negative on 01Apr2021. Therapeutic measures were taken as a result of events and treatment included Acupuncture, chiropractic, pain meds, Humira.The outcome of events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: heavy chills; shakes; fever; sweating; horrible headache; Arm was hot and sore; Arm was hot and sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EPT533), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 13:00 (at the age of 72-years-old) as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included CLL (chronic lymphositic lukemia) and covid prior to vaccination. Concomitant medications (other medications in two weeks) included atorvastatin (ATORVASTATIN), fluoxetine (FLUOXETINE), alprazolam (ALPRAZOLAM) taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. Known allergies was reported as no. Patient had covid prior to vaccination and patient was not tested with covid after vaccination. On 15Apr2021 01:00 after 12 hours after first vaccination patient experienced very heavy chills and shakes along with fever and sweating profusily along with a horrible headache all symptoms lasted for 12 to 14 hours and arm was hot and sore for about 12 hours or so. The patient did not receive treatment for events. The outcome of events was recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: heavy chills; shakes; fever; sweating; horrible headache; Arm was hot and sore; Arm was hot and sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EPT533), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 13:00 (at the age of 72-years-old) as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included CLL (chronic lymphositic lukemia) and covid prior to vaccination. Concomitant medications (other medications in two weeks) included atorvastatin (ATORVASTATIN), fluoxetine (FLUOXETINE), alprazolam (ALPRAZOLAM) taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. Known allergies was reported as no. Patient had covid prior to vaccination and patient was not tested with covid after vaccination. On 15Apr2021 01:00 after 12 hours after first vaccination patient experienced very heavy chills and shakes along with fever and sweating profusily along with a horrible headache all symptoms lasted for 12 to 14 hours and arm was hot and sore for about 12 hours or so. The patient did not receive treatment for events. The outcome of events was recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: body aches; chills; low grade fever; headache; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication within 2 weeks of vaccination included cyanocobalamin; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); desogestrel, ethinylestradiol (ISIBLOOM) and topiramate taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 11:15 as dose 1, single for COVID-19 immunization and experienced fatigue, headache, sore arm. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient experienced body aches, chills, low grade fever and headache on an unspecified date. The clinical outcome of all the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: Blotchy facial redness and puffiness, almost like hives, after both doses lasting two days.; Blotchy facial redness and puffiness, almost like hives, after both doses lasting two days.; This is a spontaneous report from a contactable consumer (patient).  A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, in Left Arm on 08Apr2021 02:00 PM (at the age of 43-years) as DOSE 1, SINGLE for covid-19 immunization. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, via an unspecified route of administration, in Left Arm on 30Apr2021 02:30 PM as DOSE 2, SINGLE for covid-19 immunization. Medical history included hypertension, depression from an unknown date and unknown if ongoing. The Patient was allergic to wellbutrin. Patient not had covid prior vaccination and patient had not undergone any covid tested post vaccination. Patient had not received any other vaccine in four weeks. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE); cetirizine hydrochloride (ZYRTEC ALLERGY); propranolol hydrochloride (INDERAL LA) taken for an unspecified indication, start and stop date were not reported. On 01May2021 08:00, the patient experienced blotchy facial redness and puffiness, almost like hives, after both doses lasting two days. Patient had not received any treatment for the events reported. Outcome of events was recovered on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: POT syndrome has occurred 10 times since initial vaccine worsening post second vaccine; This is a spontaneous report from a contactable consumer (Patient). A 17-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 28Apr2021 at 15:15 as DOSE 2, SINGLE for covid-19 immunization(age at vaccination 17-years-old). The patient's medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication(s) included vitamin d3 taken for an unspecified indication, start and stop date were not reported. Historical vaccination included first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on 07Apr2021 at 15:15 as DOSE 1, SINGLE for covid-19 immunization and experienced pot syndrome has occurred 10 times since initial vaccine. No other vaccine in four weeks. Other medications in two weeks was Vitamin D3. No Known allergies. No covid prior vaccination. No covid tested post vaccination. The adverse event resulted in physician office visit. On an unspecified date the patient experienced pot syndrome has occurred 10 times since initial vaccine worsening post second vaccine. Treatment received for the event. The outcome of the event was reported as not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: 16 hours after dose 2 headache/Mild headache for two days.; chills; 99.9 F fever; tired; This is a spontaneous report from a contactable consumer or other non-Health care professional. A 51-years-old female patient received bnt162b2 (BNT162B2, solution for injection, lot number was not reported, expiry date was not reported), dose 2 via an unspecified route of administration on Apr2021 (Age at vaccination-51 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2, solution for injection, dose 1 via an unspecified route of administration on Apr2021 at the age of 51-year-old as dose 1 single for Covid-19 immunization with reaction Tired and had Injection site soreness. On Apr2021 the patient experienced 16 hours after dose 2 headache/mild headache for two days, chills, 99.9 F fever, tired. On Apr2021 the patient underwent lab tests and procedures which included body temperature was 99.9 fahrenheit. Patient was not hospitalized. Seriousness as no. The patient had received any other vaccine within 4 weeks was unknown. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination was unknown. The clinical outcome of the events was recovered on unspecified date Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Back pain, Cough, Feeling abnormal, Headache
Clinical narrative: Migraine; headache; sinus headache; migraine which turns into tension; tension; nauseous; agitated; terrible cough; insomnia; foggy brain; vertigo; lower back have seized up in pain; doing and saying stupid stuff; neck and lower back have seized up in pain.; neck and lower back have seized up in pain.; This is a spontaneous report from a contactable consumer (patient). A 63-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Batch/Lot Number: ew0171) via an unspecified route of administration, administered in Arm Left on 22Apr2021 at 11:45 as DOSE 2, SINGLE for covid-19 immunization (age at vaccination 63-years-old). The patient's medical history included hypothyroidism, menopause, GAD and Allergy: sulfa from an unknown date and unknown if ongoing. Historical vaccination included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Batch/Lot Number: er8737) via an unspecified route of administration, administered in Arm Left on 01Apr2021 at 11:45 as DOSE 1, SINGLE for covid-19 immunization and the patient experienced migraine, achy, temperature, nauseous, fatigue, insomnia, agitated, muscle aches, lasted 4 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies to trazodone, codeine, steriods, sulfa. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient did not receive any other medications within 2 weeks of vaccination. the adverse event resulted in physician office visit. On an unspecified date of Apr2021 the patient experienced migraine which turns into tension, to vise grip headache to sinus headache, nauseous, agitated, terrible cough, insomnia, foggy brain, vertigo, doing and saying stupid stuff neck and lower back have seized up in pain. Its been 2 weeks. No hospitalization was reported. On 25Apr2021, the patient underwent lab test for COVID-19, post vaccination Nasal Swab and reported as negative. Treatment given with zpak rx told to take Excedrin, Adevele had m. The outcome for the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Mood altered, Musculoskeletal stiffness, Nausea
Clinical narrative: Migraine; headache; sinus headache; migraine which turns into tension; tension; nauseous; agitated; terrible cough; insomnia; foggy brain; vertigo; lower back have seized up in pain; doing and saying stupid stuff; neck and lower back have seized up in pain.; neck and lower back have seized up in pain.; This is a spontaneous report from a contactable consumer (patient). A 63-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Batch/Lot Number: ew0171) via an unspecified route of administration, administered in Arm Left on 22Apr2021 at 11:45 as DOSE 2, SINGLE for covid-19 immunization (age at vaccination 63-years-old). The patient's medical history included hypothyroidism, menopause, GAD and Allergy: sulfa from an unknown date and unknown if ongoing. Historical vaccination included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Batch/Lot Number: er8737) via an unspecified route of administration, administered in Arm Left on 01Apr2021 at 11:45 as DOSE 1, SINGLE for covid-19 immunization and the patient experienced migraine, achy, temperature, nauseous, fatigue, insomnia, agitated, muscle aches, lasted 4 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies to trazodone, codeine, steriods, sulfa. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient did not receive any other medications within 2 weeks of vaccination. the adverse event resulted in physician office visit. On an unspecified date of Apr2021 the patient experienced migraine which turns into tension, to vise grip headache to sinus headache, nauseous, agitated, terrible cough, insomnia, foggy brain, vertigo, doing and saying stupid stuff neck and lower back have seized up in pain. Its been 2 weeks. No hospitalization was reported. On 25Apr2021, the patient underwent lab test for COVID-19, post vaccination Nasal Swab and reported as negative. Treatment given with zpak rx told to take Excedrin, Adevele had m. The outcome for the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, SARS-CoV-2 test, Sinus headache, Tension, Tension headache
Clinical narrative: Migraine; headache; sinus headache; migraine which turns into tension; tension; nauseous; agitated; terrible cough; insomnia; foggy brain; vertigo; lower back have seized up in pain; doing and saying stupid stuff; neck and lower back have seized up in pain.; neck and lower back have seized up in pain.; This is a spontaneous report from a contactable consumer (patient). A 63-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Batch/Lot Number: ew0171) via an unspecified route of administration, administered in Arm Left on 22Apr2021 at 11:45 as DOSE 2, SINGLE for covid-19 immunization (age at vaccination 63-years-old). The patient's medical history included hypothyroidism, menopause, GAD and Allergy: sulfa from an unknown date and unknown if ongoing. Historical vaccination included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Batch/Lot Number: er8737) via an unspecified route of administration, administered in Arm Left on 01Apr2021 at 11:45 as DOSE 1, SINGLE for covid-19 immunization and the patient experienced migraine, achy, temperature, nauseous, fatigue, insomnia, agitated, muscle aches, lasted 4 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies to trazodone, codeine, steriods, sulfa. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient did not receive any other medications within 2 weeks of vaccination. the adverse event resulted in physician office visit. On an unspecified date of Apr2021 the patient experienced migraine which turns into tension, to vise grip headache to sinus headache, nauseous, agitated, terrible cough, insomnia, foggy brain, vertigo, doing and saying stupid stuff neck and lower back have seized up in pain. Its been 2 weeks. No hospitalization was reported. On 25Apr2021, the patient underwent lab test for COVID-19, post vaccination Nasal Swab and reported as negative. Treatment given with zpak rx told to take Excedrin, Adevele had m. The outcome for the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Migraine; headache; sinus headache; migraine which turns into tension; tension; nauseous; agitated; terrible cough; insomnia; foggy brain; vertigo; lower back have seized up in pain; doing and saying stupid stuff; neck and lower back have seized up in pain.; neck and lower back have seized up in pain.; This is a spontaneous report from a contactable consumer (patient). A 63-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Batch/Lot Number: ew0171) via an unspecified route of administration, administered in Arm Left on 22Apr2021 at 11:45 as DOSE 2, SINGLE for covid-19 immunization (age at vaccination 63-years-old). The patient's medical history included hypothyroidism, menopause, GAD and Allergy: sulfa from an unknown date and unknown if ongoing. Historical vaccination included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Batch/Lot Number: er8737) via an unspecified route of administration, administered in Arm Left on 01Apr2021 at 11:45 as DOSE 1, SINGLE for covid-19 immunization and the patient experienced migraine, achy, temperature, nauseous, fatigue, insomnia, agitated, muscle aches, lasted 4 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies to trazodone, codeine, steriods, sulfa. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient did not receive any other medications within 2 weeks of vaccination. the adverse event resulted in physician office visit. On an unspecified date of Apr2021 the patient experienced migraine which turns into tension, to vise grip headache to sinus headache, nauseous, agitated, terrible cough, insomnia, foggy brain, vertigo, doing and saying stupid stuff neck and lower back have seized up in pain. Its been 2 weeks. No hospitalization was reported. On 25Apr2021, the patient underwent lab test for COVID-19, post vaccination Nasal Swab and reported as negative. Treatment given with zpak rx told to take Excedrin, Adevele had m. The outcome for the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: heavy chills; body shaking; fever; sweating; painful headache; arm receiving vaccine has been very swollen; very hot to the touch; not able to get up and about to do daily routine; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection (Batch/Lot Number: EWD167), via an unspecified route of administration, administered in Arm Right on 05May2021 at 13:00 (at the age of 72-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included chronic lymphocytic leukaemia and Covid-19 prior to vaccination. No known allergies were reported. Covid was not tested post vaccination. No other vaccines were given in four weeks. Concomitant medication included atorvastatin 10 mg taken for an unspecified indication, fluoxetine 20 mg taken for an unspecified indication, alprazolam 1 mg taken for an unspecified indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection (Batch/Lot Number: EPT533), dose 1, via an unspecified route of administration, administered in Arm Right on 14Apr2021 at 13:00 (at the age of 72-Years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 06May2021 at 01:30 approximately 12.5 hours after vaccination, the patient experienced heavy chills, body shaking, fever, sweating, painful headache, arm receiving vaccine has been very swollen for 3 days, very hot to the touch, not able to get up and about to do daily routine. Patient had heard people mention having reactions, but most are having vaccination reactions after the second Pfizer vaccination. Patient don't know of anyone having reactions after both vaccines. At the time of this report, the outcome of events was unknown.  No follow-up attempts are possible. No further information is expected
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Tremor
Clinical narrative: heavy chills; body shaking; fever; sweating; painful headache; arm receiving vaccine has been very swollen; very hot to the touch; not able to get up and about to do daily routine; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection (Batch/Lot Number: EWD167), via an unspecified route of administration, administered in Arm Right on 05May2021 at 13:00 (at the age of 72-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included chronic lymphocytic leukaemia and Covid-19 prior to vaccination. No known allergies were reported. Covid was not tested post vaccination. No other vaccines were given in four weeks. Concomitant medication included atorvastatin 10 mg taken for an unspecified indication, fluoxetine 20 mg taken for an unspecified indication, alprazolam 1 mg taken for an unspecified indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection (Batch/Lot Number: EPT533), dose 1, via an unspecified route of administration, administered in Arm Right on 14Apr2021 at 13:00 (at the age of 72-Years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 06May2021 at 01:30 approximately 12.5 hours after vaccination, the patient experienced heavy chills, body shaking, fever, sweating, painful headache, arm receiving vaccine has been very swollen for 3 days, very hot to the touch, not able to get up and about to do daily routine. Patient had heard people mention having reactions, but most are having vaccination reactions after the second Pfizer vaccination. Patient don't know of anyone having reactions after both vaccines. At the time of this report, the outcome of events was unknown.  No follow-up attempts are possible. No further information is expected
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Nasal discomfort, Nasal dryness, Parosmia
Clinical narrative: On the morning of 11May2921 I blew my nose and looked like a piece of dried blood was on the tissue, and nose feels dried out; On the morning of 11May2921 I blew my nose and looked like a piece of dried blood was on the tissue, and nose feels dried out; On 08May2021 at 2000 hrs. started smelling a diesel fuel odor; aeration in sinus canal as I was sitting or laying down (was at hotel); This is a spontaneous report from a contactable consumer (Patient reported for herself that).   A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0179), via unspecified route of administration in right arm on 06May2021: 17:30 as DOSE 2, SINGLE for COVID-19 immunization (Age at vaccination:55-Year-old). Medical history included PE, Sarcoidosis. Patient concomitant medications were not reported. Patient had no known allergies. The patient previously received BNT162b2 (COMIRNATY, Batch/Lot Number: EW0150) via an unspecified route of administration in left arm 14Apr2021:01.30 PM, as DOSE 1, SINGLE for COVID-19 immunization and experienced had slight headache on 14Apr2021 about 1hour after lasting about 4 hours and soreness in left arm on 15Apr2021.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and had received dietary supplements within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 08May2021: 08:00 PM Patient started smelling a diesel fuel odor and have aeration in sinus canal as he was sitting or laying down. On 09May2021, when he move or do any activity it will go away. This event does not interfere with other odors, he can smell and taste food, and other odors. On the morning of 11May2021, he blew his nose and looked like a piece of dried blood was on the tissue, and nose felt dried out. Sinus canal still felt aerated. Patient did not receive any treatment. The outcome of the events were Not recovered  No follow-up attempts are required. No further information is expected
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain
Clinical narrative: First dose: Body aches; First dose: Joint Pain; First dose: headache; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158), dose 1 via an unspecified route of administration, administered in left arm on 13Apr2021 09:15 (at age of 53-year-old) as dose 1, single for covid-19 immunization. Medical history included atrial fibrillation (Verbatim: Afib; Caller wants to say this occurred like 8 years ago), inflammation, blood pressure abnormal. Concomitant medications included metoprolol (METOPROLOL) taken for blood pressure abnormal; diclofenac (DICLOFENAC) taken for inflammation. The patient previously took flu shot for immunisation (caller receives flu shot every year with no issue). On 13Apr2021 20:00, the patient experienced first dose: body aches, first dose: joint pain, first dose: headache. The outcome of events was recovered on 14Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Arthralgia, Back pain, Breast pain, Sleep disorder
Clinical narrative: I have not had a period; Breast hurt; Injection site hurt every now and then; My sleep was disturbed and only sleep a total of about 3 hours a night; Vision in my right eye is blurry; Back and joint pain; Back and joint pain; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EP6955 and Expiration date was not reported) via an unspecified route of administration, administered in the right arm on an unspecified date in 2021 as dose 2, single (at the age of 37-year-old) for COVID-19 immunization. The patient's relevant medical history was not reported. The patient previously took Naloxone (manufacturer unknown) and experienced allergy to Naloxone on an unspecified date. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EP7534 and Expiration date was not reported) via an unspecified route of administration, administered in the left arm on 29Mar2021 at 15:15 hours as dose 1, single (at the age of 37-year-old) for COVID-19 immunization and experienced injection site hurt every now and then. Patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included alprazolam (Xanax), buprenorphine hydrochloride (Subutex), unspecified probiotics (manufacturer unknown) and unspecified vitamins (manufacturer unknown), all from an unknown date for an unknown indication and unknown if they were ongoing. Patient was not diagnosed with COVID-19, prior to the vaccination and had not been tested for COVID-19, since the vaccination. On 25Apr2021 at 14:30 hours, patient had not had a period, breast hurt, injection site hurt every now and then, patient's sleep was disturbed and only slept a total of about 3 hours a night, vision in her right eye was blurry and back and joint pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The outcome of had not had a period, breast hurt, injection site hurt every now and then, patient's sleep was disturbed and only slept a total of about three hours a night, vision in her right eye is blurry, back and joint pain was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vision blurred
Clinical narrative: I have not had a period; Breast hurt; Injection site hurt every now and then; My sleep was disturbed and only sleep a total of about 3 hours a night; Vision in my right eye is blurry; Back and joint pain; Back and joint pain; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EP6955 and Expiration date was not reported) via an unspecified route of administration, administered in the right arm on an unspecified date in 2021 as dose 2, single (at the age of 37-year-old) for COVID-19 immunization. The patient's relevant medical history was not reported. The patient previously took Naloxone (manufacturer unknown) and experienced allergy to Naloxone on an unspecified date. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EP7534 and Expiration date was not reported) via an unspecified route of administration, administered in the left arm on 29Mar2021 at 15:15 hours as dose 1, single (at the age of 37-year-old) for COVID-19 immunization and experienced injection site hurt every now and then. Patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included alprazolam (Xanax), buprenorphine hydrochloride (Subutex), unspecified probiotics (manufacturer unknown) and unspecified vitamins (manufacturer unknown), all from an unknown date for an unknown indication and unknown if they were ongoing. Patient was not diagnosed with COVID-19, prior to the vaccination and had not been tested for COVID-19, since the vaccination. On 25Apr2021 at 14:30 hours, patient had not had a period, breast hurt, injection site hurt every now and then, patient's sleep was disturbed and only slept a total of about 3 hours a night, vision in her right eye was blurry and back and joint pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The outcome of had not had a period, breast hurt, injection site hurt every now and then, patient's sleep was disturbed and only slept a total of about three hours a night, vision in her right eye is blurry, back and joint pain was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Inappropriate schedule of product administration, Migraine
Clinical narrative: Horrible migraine; bad asthma flair up; Dose 1 on 26Apr2021 and dose 2 on 10May2021; This is a spontaneous report from a contactable consumer (patient).   A 36-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Er8733, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Right on 10May2021 at 12:00 (age at vaccination: 36years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Historical vaccine included dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ew0164, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Right on 26Apr2021 at 12:00 as dose 1, single for COVID-19 immunization. On 11May2021 at 08:00 the patient experienced horrible migraine and bad asthma flair up. Patient took dose 1 on 26Apr2021 and dose 2 on 10May2021, where the patient was exposed to inappropriate schedule of product administration. Therapeutic measures were taken as a result of horrible migraine and bad asthma flair up. AE resulted in doctor or other healthcare professional office/clinic visit. Treatment with nebulizer treatment for asthma. The outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: a red, sometimes hot, sometimes itchy, slightly raised rash began on my left breast and continued to spread down my entire abdomen, right breast, and left leg (quickly); a red, sometimes hot, sometimes itchy, slightly raised rash began on my left breast and continued to spread down my entire abdomen, right breast, and left leg (quickly); a red, sometimes hot, sometimes itchy, slightly raised rash began on my left breast and continued to spread down my entire abdomen, right breast, and left leg (quickly); hives; sometimes itchy; This is a spontaneous report from a contactable consumer. This 31-year-old non-pregnant female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0172, Expiry date: unknown), via an unspecified route of administration, administered in Arm Right on 24Apr2021 12:15 (at the age of 31 years old) as dose 2, single for covid-19 immunization. Medical history included anxiety and Known allergies to Penicillin, sulfa and patient also had covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medication(s) included escitalopram oxalate (LEXAPRO, 20 mg, 1x/day) and gabapentin (100 mg, 1x/day). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8734, Expiry date: unknown), via an unspecified route of administration, administered in Arm Right on 03Apr2021 12:15 (at the age of 31 years old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Lexapro 20mg/day and gabapentin 100mg/day within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced a red, sometimes hot, sometimes itchy, slightly raised rash began on my left breast and continued to spread down my entire abdomen, right breast, and left leg, hives on 27Apr2021 recovering. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures (Prednisone, 40mg/day, xyzal 5mg/day) were taken as a result of the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pyrexia, Vaccination site pain
Clinical narrative: Pain and tenderness at injection site; migraine; mild fever; fatigue; Pain and tenderness at injection site; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself). A 20-years-old non pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0182, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 07May2021 11:45 (at the age of 20-years-old) as dose 2, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0164) administered in Arm Left on 16Apr2021 11:15 am (at the age of 20-years-old) for COVID-19 immunisation. On 07May2021 23:00 the patient experienced pain and tenderness at injection site, migraine, mild fever and fatigue. Patient did not receive the treatment for events. The outcome of events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: Bloody sclera in right eye
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pruritus, Rash erythematous
Clinical narrative: Feeling of itchiness over medial right elbow area and extending down medial side of arm to end of right 5th finger. There were 5-7 small reddened spots near elbow area initially but these have disappeared. Also an episode of twitching or spasm as of today of right 4th and 5th finger which resolved spontaneously. Ibuprofen nor cetirizine really did not help. Severity described as annoying but not extremely painful. Ice pack has been most helpful.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: low grade fever; arm was sore; This is a spontaneous report from a Non-contactable consumer (patient herself). This 23-year-old non-pregnant female consumer (patient) reported that: A 23-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: EW0164) via an unspecified route of administration, administered in Arm Left on 08May2021 (at the age of 23 years) as dose 2, single for COVID-19 immunisation. Medical history included food allergy: Shellfish, glucose tolerance impaired, covid-19 from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, levonorgestrel (DAYSEE) taken for an unspecified indication, start and stop date were not reported; fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported; hydroxyzine (HYDROXYZINE) taken for an unspecified indication, start and stop date were not reported. She received metformin, daysee, prozac, hydroxyzine in two weeks. Prior to vaccination she had tested positive for COVID-19. She did not have COVID post vaccination. She did not receive any other vaccine in four weeks. Historical vaccine included first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number was not reported) via an unspecified route of administration, administered in Arm Left on 17Apr2021 as single for COVID-19 immunisation and experienced Pain, sore arm. The patient experienced arm was sore immediately on 08May2021 and passed on day two after the dose, she had a low-grade fever the day after the shot on 09May2021. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Fatigue, Headache, Impaired work ability, Irritability
Clinical narrative: First vaccine was July next was in August. I have not had a period since July. Also following my July vaccine I started experiencing debilitating migraines. They have significantly got worse each month. I am now on migraine meds that don't help me. They were doubled in dosage - still not working. I'm constantly exhausted and have muscle aches throughout my body. I now have to get weekly massages. I have an upcoming appointment for an MRI of my head as well as an appointment with a neurologist. I've had 2 panels of blood taken to find answers and no answers. The migraines are lasting 2-3 days and most days I wake up with a headache. I've had headaches for as long as 8 days straight. I can't work. I can't help my kids. I'm losing a good third of each month to the pain. I'm irritable and can not take another month of this pain I've been enduring.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Loss of personal independence in daily activities, Migraine, Myalgia, Pain
Clinical narrative: First vaccine was July next was in August. I have not had a period since July. Also following my July vaccine I started experiencing debilitating migraines. They have significantly got worse each month. I am now on migraine meds that don't help me. They were doubled in dosage - still not working. I'm constantly exhausted and have muscle aches throughout my body. I now have to get weekly massages. I have an upcoming appointment for an MRI of my head as well as an appointment with a neurologist. I've had 2 panels of blood taken to find answers and no answers. The migraines are lasting 2-3 days and most days I wake up with a headache. I've had headaches for as long as 8 days straight. I can't work. I can't help my kids. I'm losing a good third of each month to the pain. I'm irritable and can not take another month of this pain I've been enduring.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, International normalised ratio, Prothrombin time, Pruritus
Clinical narrative: Purple & blue bruising under my skin on L leg, brief itchiness redness and hives that disappeared
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Purple & blue bruising under my skin on L leg, brief itchiness redness and hives that disappeared
Age: 34.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Chronic tinnitus in left ear
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Swelling, Urticaria
Clinical narrative: 12 days after my booster shot, I started getting hives. It started slowly at first, but now on day 3 it's full-blown hives. Red, really itchy, in some places swollen and painful. Some hives are disappearing and reappearing, others are just staying put. They're all over my body. Antihistamines aren't helping.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Death, Hyperhidrosis, Hypoxia, Influenza A virus test negative
Clinical narrative: Report made to agency 11/16/2021 @ 17:45: Severe respiratory distress, profuse diaphoresis, hypoxia, tachycardia 11/16/2021 @ 18:06: Respiratory arrest 11/16/2021 @ 18:10: Ventricular fibrillation, cardiac arrest. Unsuccessful resuscitation. Time of death 18:52 on 11/16/2021
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza B virus test, Respiratory arrest, Respiratory distress, Respiratory syncytial virus test negative, Resuscitation
Clinical narrative: Report made to agency 11/16/2021 @ 17:45: Severe respiratory distress, profuse diaphoresis, hypoxia, tachycardia 11/16/2021 @ 18:06: Respiratory arrest 11/16/2021 @ 18:10: Ventricular fibrillation, cardiac arrest. Unsuccessful resuscitation. Time of death 18:52 on 11/16/2021
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Tachycardia, Troponin I increased, Ventricular fibrillation
Clinical narrative: Report made to agency 11/16/2021 @ 17:45: Severe respiratory distress, profuse diaphoresis, hypoxia, tachycardia 11/16/2021 @ 18:06: Respiratory arrest 11/16/2021 @ 18:10: Ventricular fibrillation, cardiac arrest. Unsuccessful resuscitation. Time of death 18:52 on 11/16/2021
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Swelling
Clinical narrative: Severe swelling, pain, fatigue, low grade fever
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eczema, Laboratory test, Urticaria
Clinical narrative: Started to get hives in October. Brought my daughter to ER. Administered Benadryl pills but got worse. Next, they infused her with dexamethosone, famotidine, diphenhydramine. It calmed the hives down. ER sent us home with Prednisone and famotidine. Next day, she got hives again. Went to the ER again, but hive started going away while waiting so we left. That night hives returned but only at her feet. She slept through it. Woke up the next day with hives again. Met with her Immunologist that day and told to take Zyrtec. Hives went away within a day. Continued on Zyrtec AM and PM and famotidine for a week. Following week, Zyrtec AM and PM only. Following week, Zyrtec AM only. Following week, no medicine. 3 days following her last dose of Zyrtec, she broke out into hives again + bad eczema flare up. Put her back on Zyrtec to calm it down. She did lab work today ordered by her immunologist - 8 vials of blood. Will get her results in a week.