chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, SARS-CoV-2 test
Clinical narrative: She also added that she has had the COVID disease; She also added that she has had the COVID disease; Chest pain feeling like heart attack; she feels like she is going to die; Woke up 12Jul2021 at 01:00 in excruciating pain; Having severe muscle cramps now/severe muscle cramps now was reported as worsened; Dealing with slurred Speech; Has memory loss; Losing sense of balance; Has really severe kidney pain on the right side as well; Felt a little bit tired; This is a spontaneous report from a contactable consumer (patient). A female patient of 32-year-old age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was WAG13871 ), first dose via an unspecified route of administration on left arm on 11Jul2021, 15:00 at unknown dose single for COVID-19 immunization. Medical history includes seizure disorder, 20 major surgeries, ortopedic bone surgery, heart attack, post op pain, vision impaired. Family Medical History includes patient father died of heart attack. No concomitant medication reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine . On 12Jul2021 patient start experiencing excruciating pain, , having severe muscle cramps, dealing with slurred Speech, memory loss, Losing sense of balance, Has really severe kidney pain on the right side, The tiredness  about 3 hours later, Chest pain. She was tested positive after vaccination. She cannot afford to go to the emergency room or the physicians office right now. She comes from a HCP family and is HCP herself. When asked to specify what type, she mentioned withheld. She is a resident of withheld, currently in withheld. She mentioned she is aware of the expected side effects with the Pfizer BioNTech. Outcome of she had covid disease, losing sense of balance, chest pain feeling like heart attack, she feels like she is going to die was unknown, recovered from fatigue, outcome of pain, Dealing with slurred Speech, has memory loss, has really severe kidney pain on the right side as well was recovering, outcome of having severe muscle cramps now/severe muscle cramps now was reported as worsened was not recovered   Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Iritis, Uveitis
Clinical narrative: Iritis/Uveitis in left eye four days after second vaccination.; Iritis/Uveitis in left eye four days after second vaccination.; This is a spontaneous report from a contactable consumer (Patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Lot Number: EW0176), via an unspecified route of administration, administered in left arm on 08May2021 at 12:00 PM (at the age of 41-years-old), as dose 2, single for COVID-19 immunisation. Medical history included ankylosing spondylitis. The patient had no known allergies. The patient concomitant medications included unspecified medications in two weeks of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Lot Number: EW0158), via an unspecified route of administration, administered in left arm on 17Apr2021 at 12:00 PM (at the age of 41-years-old), as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. The patient had no covid prior vaccination. On 12May2021 at 12:00 PM, the patient experienced iritis/uveitis in left eye four days after second vaccination. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received opthalmic treatment for events. The was not tested for COVID-19 post vaccination. The outcome of the events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Fatigue, Migraine, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: lost all feeling in my left hand; getting migraines 1-2x a week; more tired than I used to be; pain and stiffness in left hand that feels like what I imagine arthritis to feel like; pain and stiffness in left hand that feels like what I imagine arthritis to feel like; pain and stiffness in left hand that feels like what I imagine arthritis to feel like; pain and stiffness in left hand; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5398, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Feb2021 at 13:00 hours as dose 2, single (at the age of 41-years-old) for covid-19 immunisation at Clinic/ Administration facility. Medical history included ongoing migraine (got one every year or so), tired and known allergies to shellfish from an unknown date and unknown if ongoing. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications within 2 weeks of vaccination. Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246, Expiration date and NDC number was not reported), via an unspecified route of administration, administered in left arm on 15Jan2021 at 13:00 hours as dose 1, single (at the age of 41-years-old) for covid-19 immunisation. Patient was not diagnosed with COVID-19, prior to vaccination. On 01Mar2021, since her second vaccine, patient had pain and stiffness in her left hand that feels like what she imagines was arthritis to feel like, getting migraines 1-2x a week (previously she got one every year or so), and she was more tired than she used to be. On Jun2021, when she flew via airplane, patient lost all feeling in her left hand and it had hurt much more since then. Patient considered all the events serious (disabling/incapacitating). Patient went to doctor or other healthcare professional office/clinic visit for disability or permanent damage. Patient had been tested for COVID-19 by nasal swab, Sofia Antigen on 12Jul2021 and result was negative. Therapeutic measures were taken as a result Imatrex for migraines Motrin for hand. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sensory loss, Vaccination site pain
Clinical narrative: lost all feeling in my left hand; getting migraines 1-2x a week; more tired than I used to be; pain and stiffness in left hand that feels like what I imagine arthritis to feel like; pain and stiffness in left hand that feels like what I imagine arthritis to feel like; pain and stiffness in left hand that feels like what I imagine arthritis to feel like; pain and stiffness in left hand; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5398, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Feb2021 at 13:00 hours as dose 2, single (at the age of 41-years-old) for covid-19 immunisation at Clinic/ Administration facility. Medical history included ongoing migraine (got one every year or so), tired and known allergies to shellfish from an unknown date and unknown if ongoing. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications within 2 weeks of vaccination. Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246, Expiration date and NDC number was not reported), via an unspecified route of administration, administered in left arm on 15Jan2021 at 13:00 hours as dose 1, single (at the age of 41-years-old) for covid-19 immunisation. Patient was not diagnosed with COVID-19, prior to vaccination. On 01Mar2021, since her second vaccine, patient had pain and stiffness in her left hand that feels like what she imagines was arthritis to feel like, getting migraines 1-2x a week (previously she got one every year or so), and she was more tired than she used to be. On Jun2021, when she flew via airplane, patient lost all feeling in her left hand and it had hurt much more since then. Patient considered all the events serious (disabling/incapacitating). Patient went to doctor or other healthcare professional office/clinic visit for disability or permanent damage. Patient had been tested for COVID-19 by nasal swab, Sofia Antigen on 12Jul2021 and result was negative. Therapeutic measures were taken as a result Imatrex for migraines Motrin for hand. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism
Clinical narrative: Hyperthyroid; This is a spontaneous report received from a contactable other HCP (patient, self-reported). A 49-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 31Dec2020 at 14:30 PM (age at vaccination: 49 years), as a single dose for COVID-19 immunization at doctor's office/urgent care. The patient was not pregnant at the time of vaccination. The patient's medical history included AFib, hypertension, and percocet allergy. Concomitant medications included colchicine, apixaban (ELIQUIS), flecainide, olmesartan, and omeprazole (OMEPRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 01Jul2021, she experienced hyperthyroid. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event which included pending endocrinology appt. Outcome of the event was not recovered.  Information about batch/Lot number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event hyperthyroidism cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: tinnitus/noticed a ringing in my ear; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 60-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7533, Expiration date: unknown), via an unspecified route of administration in the left arm on 01Apr2021 at 13:00 (at the age of 60-years-old) as dose 2, single for covid-19 immunisation.The patient medical history included patient had known allergies. The patient concomitant medications were not reported.The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route on 21Mar2021 at 13:00 (at the age of 60-years-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination.The patient did not receive any other medications within 2 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 15Apr2021, the patient experienced tinnitus noticed a ringing in his ear. Patient stated that prior to the vaccine he did not had any issues with my hearing. Subsequent to the vaccine he noticed a ringing in his ear.The patient underwent lab tests and procedures which included COVID Nasal Swab test was negative on 06Jul2021.The patient did not receive treatment for event. The event was assessed as serious disability. The outcome of the event was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Middle ear effusion, Nerve injury, Sudden hearing loss
Clinical narrative: Sudden sensorineural hearing loss (SSHL), commonly known as sudden deafness; Right ear had a sudden build up of fluid behind my ear drum; Nerve damage; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female non pregnant patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: FP7533) via an unspecified route of administration and administered in right arm on 04Apr2021 15:00 (at age of 51-years) as single dose and dose 2 via an unspecified route of administration and administered in right arm on 04Apr2021 (Batch/Lot Number: ER8736) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received drugs within in 2 weeks prior to the COVID 19. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient not tested for COVID-19. The patient medical history was not reported. The patient previously took sulfa [sulfadiazine] and experienced drug hypersensitivity. On 10Jun2021, my right ear had a sudden build up of fluid behind my ear drum. By the time I saw the referral ENT doctor, on 09Jun2021 it was determined that the fluid had drained away but nerve damage was suspected. Sudden sensorineural hearing loss (SSHL), commonly known as sudden deafness. On 16Jul2021 I will be having a MRI performed to rule out Acoustic Neuroma. Then hopefully I can start with direct intratympanic injection of steroids into the middle ear. However, the doctors felt that it might be too late to regain full hearing back into that ear. That the nerve damage is permanent. the adverse event result in disability and Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with Prednisone. The outcome of events was not recovered.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Eye discharge, Eye pruritus, Headache, Swelling of eyelid, Vision blurred
Clinical narrative: Headache, swollen eyelids, itchy eyes, eye discharge, blurred vision
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Cough, Malaise, Oral herpes, Pain in extremity
Clinical narrative: Cold sores, Severe Pain upper arm, High Fever, Cough, Sneezing, Runny nose, Malaise, Mucus congestion, Feeling of impeding Doom
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, Secretion discharge, Sneezing
Clinical narrative: Cold sores, Severe Pain upper arm, High Fever, Cough, Sneezing, Runny nose, Malaise, Mucus congestion, Feeling of impeding Doom
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Arthralgia, Balance disorder, Dizziness, Dyskinesia
Clinical narrative: right side weakness; tingling/ numbness in limbs; muscle twitches/ spasms; palpitations; dizziness; nerve, muscle & joint pain; nerve, muscle & joint pain; nerve, muscle & joint pain; altered sensations; heat & humidity intolerance; heat & humidity intolerance; difficulty concentrating/ finding words; balance and gait issues; balance and gait issues; fine muscle movement issues- hands; blurring vision; muscle spasms; tingling in limbs; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in right arm on 14May2021 10:45 (Age at vaccination: 22 year) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included hypothyroidism from an unknown date and unknown if ongoing and migraine from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE) taken for an unspecified indication, levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication and topiramate (TOPIRAMATE) taken for an unspecified indication. The allergies include Azithromycin. The patient previously took bnt162b2 dose 1 via an unspecified route of administration, administered in right arm on 23Apr2021, 10:45 AM   dose 1, single (lot number: ER8732) for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On an unspecified date in May2021, the patient experienced right side weakness, tingling/ numbness in limbs, muscle twitches/ spasms, palpitations, dizziness, nerve, muscle & joint pain, altered sensations, heat & humidity intolerance, difficulty concentrating/ finding words, balance and gait issues, fine muscle movement issues-hands and blurring vision. AE resulted in: Doctor or other healthcare professional office/clinic visit. The event outcome was not recovered.  No further information is expected.  Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Hemiparesis, Humidity intolerance, Hypoaesthesia, Muscle spasms
Clinical narrative: right side weakness; tingling/ numbness in limbs; muscle twitches/ spasms; palpitations; dizziness; nerve, muscle & joint pain; nerve, muscle & joint pain; nerve, muscle & joint pain; altered sensations; heat & humidity intolerance; heat & humidity intolerance; difficulty concentrating/ finding words; balance and gait issues; balance and gait issues; fine muscle movement issues- hands; blurring vision; muscle spasms; tingling in limbs; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in right arm on 14May2021 10:45 (Age at vaccination: 22 year) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included hypothyroidism from an unknown date and unknown if ongoing and migraine from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE) taken for an unspecified indication, levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication and topiramate (TOPIRAMATE) taken for an unspecified indication. The allergies include Azithromycin. The patient previously took bnt162b2 dose 1 via an unspecified route of administration, administered in right arm on 23Apr2021, 10:45 AM   dose 1, single (lot number: ER8732) for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On an unspecified date in May2021, the patient experienced right side weakness, tingling/ numbness in limbs, muscle twitches/ spasms, palpitations, dizziness, nerve, muscle & joint pain, altered sensations, heat & humidity intolerance, difficulty concentrating/ finding words, balance and gait issues, fine muscle movement issues-hands and blurring vision. AE resulted in: Doctor or other healthcare professional office/clinic visit. The event outcome was not recovered.  No further information is expected.  Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Myalgia, Neuralgia, Palpitations, Paraesthesia
Clinical narrative: right side weakness; tingling/ numbness in limbs; muscle twitches/ spasms; palpitations; dizziness; nerve, muscle & joint pain; nerve, muscle & joint pain; nerve, muscle & joint pain; altered sensations; heat & humidity intolerance; heat & humidity intolerance; difficulty concentrating/ finding words; balance and gait issues; balance and gait issues; fine muscle movement issues- hands; blurring vision; muscle spasms; tingling in limbs; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in right arm on 14May2021 10:45 (Age at vaccination: 22 year) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included hypothyroidism from an unknown date and unknown if ongoing and migraine from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE) taken for an unspecified indication, levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication and topiramate (TOPIRAMATE) taken for an unspecified indication. The allergies include Azithromycin. The patient previously took bnt162b2 dose 1 via an unspecified route of administration, administered in right arm on 23Apr2021, 10:45 AM   dose 1, single (lot number: ER8732) for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On an unspecified date in May2021, the patient experienced right side weakness, tingling/ numbness in limbs, muscle twitches/ spasms, palpitations, dizziness, nerve, muscle & joint pain, altered sensations, heat & humidity intolerance, difficulty concentrating/ finding words, balance and gait issues, fine muscle movement issues-hands and blurring vision. AE resulted in: Doctor or other healthcare professional office/clinic visit. The event outcome was not recovered.  No further information is expected.  Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory disturbance, Temperature intolerance, Vision blurred
Clinical narrative: right side weakness; tingling/ numbness in limbs; muscle twitches/ spasms; palpitations; dizziness; nerve, muscle & joint pain; nerve, muscle & joint pain; nerve, muscle & joint pain; altered sensations; heat & humidity intolerance; heat & humidity intolerance; difficulty concentrating/ finding words; balance and gait issues; balance and gait issues; fine muscle movement issues- hands; blurring vision; muscle spasms; tingling in limbs; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in right arm on 14May2021 10:45 (Age at vaccination: 22 year) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included hypothyroidism from an unknown date and unknown if ongoing and migraine from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE) taken for an unspecified indication, levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication and topiramate (TOPIRAMATE) taken for an unspecified indication. The allergies include Azithromycin. The patient previously took bnt162b2 dose 1 via an unspecified route of administration, administered in right arm on 23Apr2021, 10:45 AM   dose 1, single (lot number: ER8732) for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On an unspecified date in May2021, the patient experienced right side weakness, tingling/ numbness in limbs, muscle twitches/ spasms, palpitations, dizziness, nerve, muscle & joint pain, altered sensations, heat & humidity intolerance, difficulty concentrating/ finding words, balance and gait issues, fine muscle movement issues-hands and blurring vision. AE resulted in: Doctor or other healthcare professional office/clinic visit. The event outcome was not recovered.  No further information is expected.  Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: right side weakness; tingling/ numbness in limbs; muscle twitches/ spasms; palpitations; dizziness; nerve, muscle & joint pain; nerve, muscle & joint pain; nerve, muscle & joint pain; altered sensations; heat & humidity intolerance; heat & humidity intolerance; difficulty concentrating/ finding words; balance and gait issues; balance and gait issues; fine muscle movement issues- hands; blurring vision; muscle spasms; tingling in limbs; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in right arm on 14May2021 10:45 (Age at vaccination: 22 year) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included hypothyroidism from an unknown date and unknown if ongoing and migraine from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE) taken for an unspecified indication, levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication and topiramate (TOPIRAMATE) taken for an unspecified indication. The allergies include Azithromycin. The patient previously took bnt162b2 dose 1 via an unspecified route of administration, administered in right arm on 23Apr2021, 10:45 AM   dose 1, single (lot number: ER8732) for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On an unspecified date in May2021, the patient experienced right side weakness, tingling/ numbness in limbs, muscle twitches/ spasms, palpitations, dizziness, nerve, muscle & joint pain, altered sensations, heat & humidity intolerance, difficulty concentrating/ finding words, balance and gait issues, fine muscle movement issues-hands and blurring vision. AE resulted in: Doctor or other healthcare professional office/clinic visit. The event outcome was not recovered.  No further information is expected.  Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, SARS-CoV-2 test
Clinical narrative: Double vision going to opthamologist now neurological optomosologist next week neurologist; 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 mRNA VACCINE, Solution for injection, Lot number: Er8737, Expiration date: Not reported) via an unspecified route of administration in right arm on an unspecified date as single dose for COVID-19 immunization. The patient's medical history included high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No known allergies. Concomitant medication included losartan (within 2 weeks of vaccination). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Er8730, Expiration date: not reported), via an unspecified route of administration in left arm on 27Mar2021 10:00 (at the age of 53-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced double vision going to opthamologist now neurological optomosologist next week neurologist on 12May2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jun2021 Nasal Swab. It was unknown if patient received treatment for the event. Outcome of the event was not recovered.  No follow-up attempts needed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I know of three people that had the original 2 Pfizer shots and within 90 days contracted the variant.; I know of three people that had the original 2 Pfizer shots and within 90 days contracted the variant; This is a spontaneous report from contactable consumer or other non-health care professional via Escalation team reported for a patient (1 of 3 patients). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date: Unknown), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date: Unknown), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received original 2 Pfizer shots and within 90 days contracted the variant. The reporter understand that Pfizer was asking the FDA for 6 months booster for the covid 19 to cover the variant, but reporter know of three people that had the original 2 Pfizer shots and within 90 days contracted the variant and six months was too late. The outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021885398 Same reporter/ drug/ event, different patients.;US-PFIZER INC-2021885397 Same reporter/ drug/ event, different patients.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I know of three people that had the original 2 Pfizer shots and within 90 days contracted the variant; I know of three people that had the original 2 Pfizer shots and within 90 days contracted the variant; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported similar events for 3 patients. This is one of 3 reports. A unspecified age and gender of a patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported), dose 1 and dose 2 via an unspecified route of administration on unspecified date as DOSE 1, SINGLE and DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date, the patient received original 2 Pfizer shots and within 90 days contracted the variant. The reporter understand that Pfizer was asking the FDA for 6 months booster for the covid 19 to cover the variant, but reporter know of three people that had the original 2 Pfizer shots and within 90 days contracted the variant and six months was too late. The patient had SARS-CoV-2 test within 90 days contracted the variant and results were positive. The outcome of the event was unknown.  Information related to batch/Lot no. was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021885306 Same reporter/ drug/ event, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: Confirmed COVID-19; Confirmed COVID-19; Mild URI symptoms; Fever; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from Apr2021 (Batch/Lot number was not reported) to Apr2021, at DOSE 1, SINGLE for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced confirmed covid-19 leading to vaccination failure on 01Jul2021. mild upper respiratory tract infection and fever on 2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature of over 100+ and sars-cov-2 test: positive on 01Jul2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected..
Sex: U
Vaccine: COVID19
Symptoms: Upper respiratory tract infection
Clinical narrative: Confirmed COVID-19; Confirmed COVID-19; Mild URI symptoms; Fever; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from Apr2021 (Batch/Lot number was not reported) to Apr2021, at DOSE 1, SINGLE for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced confirmed covid-19 leading to vaccination failure on 01Jul2021. mild upper respiratory tract infection and fever on 2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature of over 100+ and sars-cov-2 test: positive on 01Jul2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected..
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Miscarriage; This is a spontaneous report received from a contactable consumer or other non hcp.This consumer reported information for both mother and fetus/baby. A female patient of an unspecified age received bnt162b2 (PFIZER-COVID19 Vaccine, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization.The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced miscarriage at 6 weeks and reported that event took place after use of product. The mother was 6 Weeks pregnant at the onset of the event. The outcome of event was unknown.     No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Drug ineffective, Incorrect dose administered, Lower respiratory tract infection
Clinical narrative: Suspect product: mRNA vaccine (Pfizer x 2, Moderna x 1); confirmed COVID-19; confirmed COVID-19; lower RTI; pulmonary involvement (Mild); This is a spontaneous report from a contactable consumer. This consumer reported for a patient that: This case for Third with lower RTI, CT scan = pulmonary involvement (mild).  A patient of unspecified age and gender received second dose of bnt162b2 (mRNA vaccine, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date in 2021 as DOSE 2, SINGLE and first dose of bnt162b2 (mRNA vaccine, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown) via an unspecified route of administration unspecified date in 2021as DOSE 1, SINGLE for covid-19 immunization. The patient also received first dose of Moderna, via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received mRNA vaccine (Pfizer x 2, Moderna x 1) between Feb and Apr2021. On 01Jul2021, the patient experienced COVID-19. In Jul2021, patient had lower RTI, and CT scan showed pulmonary involvement (mild). The outpatient was treated with ICS (inhaled corticosteroid) and close (every other day) follow-up. The patient no ''classic'' immunocompromising conditions. On 01Jul, patient tested with PCR that confirmed COVID-19 and on an unknown date in Jul2021, CT scan showed pulmonary involvement (mild). The outcome of all events were unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Lung disorder, SARS-CoV-2 test
Clinical narrative: Suspect product: mRNA vaccine (Pfizer x 2, Moderna x 1); confirmed COVID-19; confirmed COVID-19; lower RTI; pulmonary involvement (Mild); This is a spontaneous report from a contactable consumer. This consumer reported for a patient that: This case for Third with lower RTI, CT scan = pulmonary involvement (mild).  A patient of unspecified age and gender received second dose of bnt162b2 (mRNA vaccine, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date in 2021 as DOSE 2, SINGLE and first dose of bnt162b2 (mRNA vaccine, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown) via an unspecified route of administration unspecified date in 2021as DOSE 1, SINGLE for covid-19 immunization. The patient also received first dose of Moderna, via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received mRNA vaccine (Pfizer x 2, Moderna x 1) between Feb and Apr2021. On 01Jul2021, the patient experienced COVID-19. In Jul2021, patient had lower RTI, and CT scan showed pulmonary involvement (mild). The outpatient was treated with ICS (inhaled corticosteroid) and close (every other day) follow-up. The patient no ''classic'' immunocompromising conditions. On 01Jul, patient tested with PCR that confirmed COVID-19 and on an unknown date in Jul2021, CT scan showed pulmonary involvement (mild). The outcome of all events were unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, Product dose omission issue, Respiration abnormal, Suspected COVID-19
Clinical narrative: Break through cases after the Pfizer vaccine; break through cases after the Pfizer vaccine; Got sick with resp symptoms; Got sick with resp symptoms; missed her second shot; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that they have heard from our health department that there are more break through cases after the Pfizer vaccine. Stated that, reported just had a lady infected by her sister and nephew who came down from (Withheld) (both vaccinated with Pfizer). Family got sick with respiratory symptoms and infected her. She had her first shot couple weeks earlier and missed her second shot. She was hospitalized, they are not. The health department was sending these breakthrough specimens to CDC. Pfizer just requested a booster. Stated that, the reporter was curious whether that was for the delta variant only or for the wild type one as well. The outcome of the events was unknown.   Information about lot/ batch number is requested.; Sender's Comments: Based on known drug safety profile and as patient received only one shot of vaccine there is reasonable possibility of drug ineffective for Covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Respiration abnormal
Clinical narrative: break through cases after the Pfizer vaccine; break through cases after the Pfizer vaccine; got sick with resp symptoms; got sick with resp symptoms; This is a spontaneous report from a contactable Physician. This physician reported for a female patient and other two patient. A male patient (lady's nephew), of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 2021 as dose 1, single for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient experienced break through cases after the Pfizer vaccine on an, Got sick with resp symptoms on an unspecified date in 2021. Reporter was curious if this was for the variant only or for the wild type one as well. The outcome of the events was unknown.   Information about lot/ batch number is requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I just had a lady infected by her sister and nephew; I just had a lady infected by her sister and nephew; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unknown date in 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was infected by her sister and nephew who came down from withheld (both vaccinated with Pfizer). Family got sick with resp symptoms and infected her. She had her first shot couple weeks earlier and missed her second shot. She is hospitalized; they were not. The events resulted in hospitalization on an unknown date in 2021. The outcome of the events was unknown.  Follow-up attempts are needed; information about lot/batch number can be obtained.; Sender's Comments: Based on the information in the case report, A possible causal relationship between Covid-19 and suspect product BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Headache, Myalgia, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: The entire family had their Pfizer vaccinations in Mar, and all three are positive; The entire family had their Pfizer vaccinations in Mar, and all three are positive; Severe muscle aches; Headache; This is a spontaneous report from a contactable physician. A adult female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on Mar2021 as DOSE 2, SINGLE, and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The physician reported that in the last few days, the physician had four new COVID of patients after weeks of none. Three of the four were fully vaccinated, all with the Pfizer vaccine. Also, the physician was aware of two other cases in vaccinated patients who were being seen by colleagues. This might be sampling issue, but it was running contrary to the conventional wisdom that most of the cases were in unvaccinated people. A 68-year-old man (patient's father) who had a syncopal episode. He had spread it to his wife and adult daughter (patient) who were also all fully vaccinated. The patient had the same symptoms (severe muscle aches and a headache). The entire family had their Pfizer vaccinations in Mar, and all three were positive. They were more of these vaccinated cases because they were no longer routinely test vaccinated people who were not having typical presentations. It was reported that they had stopped pre-op COVID testing on fully vaccinated asymptomatic people a couple of weeks ago. They were asking if they should be going back to doing that. The reporter wondered if there were a lot more going on in the vaccinated population than they appreciate. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of events were unknown.  Information about lot/batch number has been requested. ; Sender's Comments: Based on known drug safety profile and as patient received  two shots of vaccine on unspecified dates, since there is no information of how many day are gap (19-42)between two shots there is reasonable possibility of drug ineffective for Covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Exposure to SARS-CoV-2, Malaise, Oropharyngeal pain, Paranasal sinus discomfort
Clinical narrative: Been staying with his girlfriends parents and the girlfriends father tested positive for COVID-19.; Has not been feeling well; Little chest congestion; Sore throat; Sinus pressure; Loose bowel but not diarrhea; This is a spontaneous report from a contactable consumer or other non hcp(patient).   A 43-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Sep2020 (at the age of 43-years-old) as DOSE 2, SINGLE for covid-19 immunisation.  The patient's medical history was and concomitant medications were not reported. The patient previously took BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Aug2020 as DOSE1, SINGLE for covid 19 immunisation. On 14Jul2021, the patient experienced little chest congestion, sore throat, sinus pressure, loose bowel but not diarrhea, been staying with his girlfriends parents and the girlfriends father tested positive for covid-19, has not been feeling well. Reporter and his girlfriend had been staying with his girlfriend's parents and the girlfriend's father tested positive for COVID-19. He has not been feeling well. Reporter had sore throat and a little chest congestion today (sinus pressure, loose bowel but not diarrhea got this from the callback). Reporter got the self swab, and he wants information on the clinical trial in area so he can give them a call and see if he can get in and for someone to come and pick up his swab for the study and the center. The outcome of all the events was unknown. Information about lot/batch number has been requested.