chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, SARS-CoV-2 test
Clinical narrative: Severe itchy painful rash on hands, arms, around mouth and eyes.; Severe itchy painful rash on hands, arms, around mouth and eyes.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Pfizer brand), dose number unknown via an unspecified route of administration, administered in Arm Left on 13Mar2021 12:15 PM (lot Number: EL3302) (at the vaccination age of 67-year-old) as single for COVID-19 immunisation. Medical history included Penicillin allergies and Eczema. The patient did not diagnosed as Covid prior vaccination. There were no concomitant medications. There was no other vaccine in four weeks. Other medications in two weeks was none. As reported, on 05Apr2021 03:30 PM, the patient experienced severe itchy painful rash on hands, arms, around mouth and eyes. It took about 2 months to clear up. The adverse events resulted in 'Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care'. The treatment for the events was yes with Antibiotics steroids and steroid creams. COVID tested post vaccination as nasal swab negative on 19May2021. The patient was not pregnant at vaccination. Therapeutic measures were taken as a result of severe itchy painful rash on hands, arms, around mouth and eyes. The outcome of the events was recovered on an unspecified date.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Therapeutic response unexpected
Clinical narrative: Had a stress test which told that he had atherosclerosis of the arteries. He was having these chest pains and it basically seems like they have started going away when he got the vaccines; This is a spontaneous report from a contactable consumer (the patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history included ongoing atherosclerosis of the arteries and ongoing chest pain. The patient's concomitant medications were not reported. On an unspecified date, he had a stress test which told him that he had atherosclerosis of the arteries. He was having these chest pains and it basically seems like they have started going away when he got the vaccines. Was wondering if it was actually something involved with the virus or an artery problem. Was trying to get this all figured out. Stated that the atherosclerosis and chest pains are continuing to this day. It basically seemed to start diminishing once he got the vaccine. He thought maybe it was a placebo effect. It seemed as if the vaccines, the first and second, improved his conditions but the conditions did not improve all the way. Stated that he has nothing to report but he thinks it would help to the point where he asked the medical doctor if he could get a third shot. Caller just wanted to get an idea when the expected third vaccine would be rolling out. The chest pains only start at the start of his walking and exercise. It diminishes after a while. He was just trying to figure out his health situation. He hasn't gone back to the doctor since the stress test. He hasn't actually gotten any response from the main doctor after the test. Maybe that means it must not be a concern. He was just trying to figure out about his health diagnosis and trying to reach out and figure out what to do next." On an unspecified date, the patient underwent lab tests and procedures which included stress test: he had atherosclerosis of the arteries. The outcome of event was unknown.  The lot number for [bnt162b2], was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Pyrexia
Clinical narrative: Started feeling clammy; slight chills; Mild fever; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FA7485) via an unspecified route of administration in the arm left on 26Jul2021 at 17:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 27Jul2021 at 14:00, the patient started feeling clammy, slight chills and mild fever. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started feeling clammy, slight chills and mild fever was recovering at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, C-reactive protein increased, Disease recurrence, Pyrexia
Clinical narrative: thyroiditis subacute; C-reactive protein increased; Pyrexia; Blood thyroid stimulating hormone; SARS-CoV-2 test negative; Ultrasound scan abnormal; the patient experienced SAT already after the first dose and that symptoms recurred with the second; This is a spontaneous report from a contactable consumer or other non hcp. This case is for patient 8. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 as first dose for Covid-19 immunization and experienced Subacute Thyroiditis. On an unspecified date, the patient experienced thyroiditis subacute, c-reactive protein increased, pyrexia, blood thyroid stimulating hormone, sars-cov-2 test negative, ultrasound scan abnormal. The patient underwent lab tests and procedures which included c-reactive protein: increased, sars-cov-2 test: negative, tri-iodothyronine: normal, ultrasound scan: abnormal, white blood cell count: normal. The time to onset of event was 1 month. None of the event caused hospitalization or any other seriousness criteria. It was reported that the SAT onset was after the second dose, it was mentioned that the patient experienced SAT already after the first dose and that symptoms recurred with the second (positive rechallenge). Time to onset (TTO) in this case was reported as one day after vaccination with the second dose. The patient seemed to have an underlying thyroid disorder. It was reported that the symptoms of SAT resolved when she stopped her thyroid medication. Since it was not specified what kind of medication the patient was taking, it is not possible to conclude whether it was underlying hyper or hypothyroidism. SAT is not labelled as a potential adverse reaction in the three included vaccines Summaries of Product Characteristics (SmPCs). Outcome of the events were recovered.  Follow-up (26Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient included clinical information.  Follow-up (26Jul2021): This follow up report contains no new safety information.  Follow-up (27Jul2021): This follow up report contains no new safety information.  No follow-up attempts are possible; information about Lot/Batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test negative, Thyroiditis subacute, Tri-iodothyronine, Ultrasound scan
Clinical narrative: thyroiditis subacute; C-reactive protein increased; Pyrexia; Blood thyroid stimulating hormone; SARS-CoV-2 test negative; Ultrasound scan abnormal; the patient experienced SAT already after the first dose and that symptoms recurred with the second; This is a spontaneous report from a contactable consumer or other non hcp. This case is for patient 8. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 as first dose for Covid-19 immunization and experienced Subacute Thyroiditis. On an unspecified date, the patient experienced thyroiditis subacute, c-reactive protein increased, pyrexia, blood thyroid stimulating hormone, sars-cov-2 test negative, ultrasound scan abnormal. The patient underwent lab tests and procedures which included c-reactive protein: increased, sars-cov-2 test: negative, tri-iodothyronine: normal, ultrasound scan: abnormal, white blood cell count: normal. The time to onset of event was 1 month. None of the event caused hospitalization or any other seriousness criteria. It was reported that the SAT onset was after the second dose, it was mentioned that the patient experienced SAT already after the first dose and that symptoms recurred with the second (positive rechallenge). Time to onset (TTO) in this case was reported as one day after vaccination with the second dose. The patient seemed to have an underlying thyroid disorder. It was reported that the symptoms of SAT resolved when she stopped her thyroid medication. Since it was not specified what kind of medication the patient was taking, it is not possible to conclude whether it was underlying hyper or hypothyroidism. SAT is not labelled as a potential adverse reaction in the three included vaccines Summaries of Product Characteristics (SmPCs). Outcome of the events were recovered.  Follow-up (26Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient included clinical information.  Follow-up (26Jul2021): This follow up report contains no new safety information.  Follow-up (27Jul2021): This follow up report contains no new safety information.  No follow-up attempts are possible; information about Lot/Batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan abnormal, White blood cell count
Clinical narrative: thyroiditis subacute; C-reactive protein increased; Pyrexia; Blood thyroid stimulating hormone; SARS-CoV-2 test negative; Ultrasound scan abnormal; the patient experienced SAT already after the first dose and that symptoms recurred with the second; This is a spontaneous report from a contactable consumer or other non hcp. This case is for patient 8. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 as first dose for Covid-19 immunization and experienced Subacute Thyroiditis. On an unspecified date, the patient experienced thyroiditis subacute, c-reactive protein increased, pyrexia, blood thyroid stimulating hormone, sars-cov-2 test negative, ultrasound scan abnormal. The patient underwent lab tests and procedures which included c-reactive protein: increased, sars-cov-2 test: negative, tri-iodothyronine: normal, ultrasound scan: abnormal, white blood cell count: normal. The time to onset of event was 1 month. None of the event caused hospitalization or any other seriousness criteria. It was reported that the SAT onset was after the second dose, it was mentioned that the patient experienced SAT already after the first dose and that symptoms recurred with the second (positive rechallenge). Time to onset (TTO) in this case was reported as one day after vaccination with the second dose. The patient seemed to have an underlying thyroid disorder. It was reported that the symptoms of SAT resolved when she stopped her thyroid medication. Since it was not specified what kind of medication the patient was taking, it is not possible to conclude whether it was underlying hyper or hypothyroidism. SAT is not labelled as a potential adverse reaction in the three included vaccines Summaries of Product Characteristics (SmPCs). Outcome of the events were recovered.  Follow-up (26Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient included clinical information.  Follow-up (26Jul2021): This follow up report contains no new safety information.  Follow-up (27Jul2021): This follow up report contains no new safety information.  No follow-up attempts are possible; information about Lot/Batch number could not be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neuralgia, Paraesthesia
Clinical narrative: felt twitching in face/twitching in arms and legs; jerking movements in my right lower leg; numbness in my hands and feet; nerve irritation moved upward to hips, upper legs and low back,moved into upper back and neck; tingling that started in right thumb, spread to fingers, then into right wrist, right elbow, and up right arm, nerve tingling started in feet; coordination loss currently remain; increasingly weak; stiff in my legs and back; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Right Arm on 10Jul2021 12:45 (Batch/Lot Number: EW0178) as single dose for covid-19 immunisation at the age of 37-year-old. Medical history included allergies. Concomitant medication in two weeks included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported.  Facility type vaccine: Other. If other vaccine in four weeks: No. The patient previously took tetracycline and wellbutrin and experienced allergies: tetracycline, Wellbutrin. The patient experienced felt twitching in face/twitching in arms and legs on 11Jul2021, tingling that started in right thumb, spread to fingers, then into right wrist, right elbow, and up right arm, nerve tingling started in feet on 10Jul2021 20:30, jerking movements in my right lower leg on 11Jul2021, coordination loss currently remain on Jul2021, numbness in hands and feet on 11Jul2021, nerve irritation moved upward to hips, upper legs and low back,moved into upper back and neck on 11Jul2021, increasingly weak on Jul2021, stiff in legs and back on Jul2021. Clinical course: Approximately 8 hours after receiving the shot on 10Jul2021, the patient had tingling that started in right thumb (the same arm as the vaccine). The tingling spread to fingers, then into right wrist, right elbow, and up right arm. The next day, nerve tingling started in feet. The patient had jerking movements in right lower leg. The patient started twitching in arms and legs and experienced numbness in hands and feet. The nerve irritation moved upward to hips, upper legs, and low back. By Tuesday the patient grew increasingly weak and stiff in legs and back. The patient was also losing coordination. The patient went to the hospital. The next day, the nerve irritation moved into my upper back and neck. The patient felt twitching in my face. Some twitching (arms, legs), numbness (hands, feet), weakness, and coordination loss currently remain. The patient took Aspirin on 22Jul2021 and it caused nerves to flare up again. Currently on 27Jul2021, the patient still have tingling in hands, arms, feet, and legs. If covid prior vaccination: No. If covid tested post vaccination: No. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Ae treatment: acupuncture. Outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Exposed to COVID-19 after receiving vaccination; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 08Jul2021 as dose 1, single for covid-19 immunisation. Medical history included COVID-19 (prior to receiving his COVID-19 Vaccine) from Dec2020 to an unknown date. The patient's concomitant medications were not reported.  On Jul2021. patient was exposed to COVID-19 after receiving vaccination, as his wife was tested positive for COVID-19 on 14Jul2021 and his son was tested positive on 15Jul2021 after receiving the dose 1 of vaccination. Patient is due for second shot this Thursday 29Jul2021. The outcome of the event was unknown.  Information about the Lot/batch number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Pain
Clinical narrative: eye pain some times in both eyes and sometimes only one eye; pain; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 16May2021 at 12:15 PM (Lot Number: EW0185) at the age of 54-year-old as single dose for COVID-19 immunization. Medical history was none. COVID prior vaccination was none. COVID tested post vaccination was none. Other vaccine in four weeks was none. Known allergies was none. Other medications in two weeks was none. Concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 25Apr2021 at 11:0 AM (Lot Number: EW0165) at the age of 54-year-old as single dose for COVID-19 immunization. On 18May2021 at 06:30 AM, the patient had pain. Reported as:  It was there for 3 days and then went away. I never had this issue before taking covid-19 vaccine, since then I have been getting eye pain some times in both eyes and sometimes only one eye. The pain stays for couple of days and goes away. No treatment was not received. The outcome of eye pain was not recovered. The outcome of pain was recovered on 21May2021.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: the left side of my face and neck broke out in a rash/hives; the left side of my face and neck broke out in a rash/hives; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: Ew0170), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 at 16:00 (at the age of 43-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Doctor's office/urgent care. The patient medical history included crohns and pyoderma gangrenosum. Concomitant medications received within two weeks included adalimumab (HUMIRA). The patient previously took infliximab (REMICADE) and experienced drug allergy. No other vaccine was administered in four weeks. The patient did not have covid prior vaccination. The patient reported that the left side of my face and neck broke out in a rash/hives on 25Apr2021. Patient reported that, one week after I got my first vaccine show on 19Apr, and the day after I did my humira injection, the left side of my face and neck broke out in a rash/hives. It was milder the first shot and resolved in about of week. The patient underwent lab tests and procedures which included sars-cov-2 test that was negative on 07Jul2021. It was reported that, Patient tested for covid post vaccination with Nasal Swab on 07Jul2021 that was Negative. Therapeutic measures were taken as a result of the left side of my face and neck broke out in a rash. Event resulted in the Doctor or other healthcare professional office/clinic visit. Event received treatment with Cream for the rash. The Outcome of the events was resolving.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hyperaesthesia, Paraesthesia
Clinical narrative: Sensitivity to cold and hot, sensitivity to touch on hands; Tingling in face and arms, spread to whole body; Tingling in face and arms, spread to whole body; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm (at the age of 56-year-old) on 11Mar2021 09:00 (Lot Number: EN6204) as single dose for covid-19 immunisation. Medical history included ongoing slight tingling in hands, known allergies: Penicillin and Tetracycline. Concomitant medications included lisinopril; atorvastatin; zinc; vitamin b complex. The patient experienced Tingling in face and arms, spread to whole body; Sensitivity to cold and hot, sensitivity to touch on hands and arms on 11Mar2021 09:00. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disorientation, Dizziness, Hallucination, auditory
Clinical narrative: heard people talking to me a few times (thought my husband said something when he didn't); confused disoriented and heard people talking to me a few times; dizzy / lightheaded; disoriented; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received bnt162b2 (BNT162B2), second single dose via an unspecified route of administration, administered in arm left on 24Mar2021 16:00 (Batch/Lot number was not reported) for covid-19 immunisation at age of 36-year-old. The patient previously received first single dose of bnt162b2 on 27Mar2021 at 16:00 on left arm for COVID-19 immunisation at age of 36-year-old. Medical history included asthma, high blood pressure, heartburn and acid reflux. The patient had Known allergies for Amoxicillin and penicillin bacterium. Other medications in two weeks included blood pressure and acid reflux medications. No other vaccine in four weeks received. No Covid prior vaccination and no Covid tested post vaccination. On 27Mar2021 at 12:00, following 2nd dose lightheaded dizzy confused disoriented and heard people talking to me a few times (thought my husband said something when he didn't) 18 weeks later still feel dizzy and lightheaded all day every day, and disoriented/confused at times. No treatment received for the events. Outcome of the events was not recovered.   Information about the Lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inflammation, Musculoskeletal stiffness, Neck pain
Clinical narrative: inflammation; Right neck pain; neck stiffness; body aches; severe chills; severe head ache; tinnitus; This is a spontaneous report from a contactable nurse (patient) reported for herself.  A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 54-year-old, dose 2 via an unspecified route of administration, administered in Arm Right on 19Jan2021 (Batch/Lot Number: EK9231) as dose 2, single for covid-19 immunisation in Hospital. The patient medical history was not reported. patient was not pregnant. Concomitant medication in two weeks included vit d [vitamin d nos] and vitamin k [vitamin k nos]. no other vaccine in four weeks. The patient previously took iohexol and experienced drug hypersensitivity, first dose of bnt162b2 (Brand=Pfizer, lot number: EK9231) on 29Dec2020 into right arm for covid-19 immunisation. Patient experienced right neck pain, neck stiffness, body aches, severe chills, severe headache, tinnitus 2nd day after vaccine (20Jan2021, but also reported adverse event start date was 19Jan2021), inflammation on 20Jan2021. adverse event resulted in: Doctor or other healthcare professional office/clinic visit. No Covid prior vaccination. No if Covid tested post vaccination. Treatment received for the events included Magnesium and Curcumin to reduce inflammation. patient was not recovered from the events.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tinnitus
Clinical narrative: inflammation; Right neck pain; neck stiffness; body aches; severe chills; severe head ache; tinnitus; This is a spontaneous report from a contactable nurse (patient) reported for herself.  A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 54-year-old, dose 2 via an unspecified route of administration, administered in Arm Right on 19Jan2021 (Batch/Lot Number: EK9231) as dose 2, single for covid-19 immunisation in Hospital. The patient medical history was not reported. patient was not pregnant. Concomitant medication in two weeks included vit d [vitamin d nos] and vitamin k [vitamin k nos]. no other vaccine in four weeks. The patient previously took iohexol and experienced drug hypersensitivity, first dose of bnt162b2 (Brand=Pfizer, lot number: EK9231) on 29Dec2020 into right arm for covid-19 immunisation. Patient experienced right neck pain, neck stiffness, body aches, severe chills, severe headache, tinnitus 2nd day after vaccine (20Jan2021, but also reported adverse event start date was 19Jan2021), inflammation on 20Jan2021. adverse event resulted in: Doctor or other healthcare professional office/clinic visit. No Covid prior vaccination. No if Covid tested post vaccination. Treatment received for the events included Magnesium and Curcumin to reduce inflammation. patient was not recovered from the events.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Erythema, Pain, Rash, Tongue pruritus
Clinical narrative: a rash on her right facial cheek and chest; Her right ear was also red; itchy tongue; extreme pain and soreness; patient's speech was slurred; This is a spontaneous report from a contactable pharmacist. A non-pregnant 26-year-old female patient received bnt162b2 (brand Pfizer), dose 2 intramuscular, administered in arm left on 13May2021 17:45 (Batch/Lot Number: EW0168) as dose 2, single for covid-19 immunisation. Dose 1 was received on an unknown date for covid-19 immunisation. Medical history included known allergies: Penicillin. Facility type vaccine is hospital. No other vaccine in four weeks. Other medications in two weeks included inpatient medications. It was unknown if covid prior vaccination and if covid tested post vaccination. Patient reported extreme pain and soreness on 14May2021 12:00, the day following the vaccine. Two days after her second vaccine shot (15May2021), she presented with a rash on her right facial cheek and chest. Her right ear was also red and the patient complained of having an "itchy tongue." A few hours later, the patient reported that the pain was getting worse. RN did full assessment and found that the patient's rash had become worse on her ear and that the patient's speech was slurred. Vital signs were obtained and WNL (May2021). Patient not experiencing any respiratory distress. Patient send to ED to evaluate for adverse reaction. Patient returned later that evening. Adverse event resulted in emergency room/department or urgent care. The treatment included acetaminophen and diphenhydramine. The patient was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported serious unlisted event namely "Pain" cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: a rash on her right facial cheek and chest; Her right ear was also red; itchy tongue; extreme pain and soreness; patient's speech was slurred; This is a spontaneous report from a contactable pharmacist. A non-pregnant 26-year-old female patient received bnt162b2 (brand Pfizer), dose 2 intramuscular, administered in arm left on 13May2021 17:45 (Batch/Lot Number: EW0168) as dose 2, single for covid-19 immunisation. Dose 1 was received on an unknown date for covid-19 immunisation. Medical history included known allergies: Penicillin. Facility type vaccine is hospital. No other vaccine in four weeks. Other medications in two weeks included inpatient medications. It was unknown if covid prior vaccination and if covid tested post vaccination. Patient reported extreme pain and soreness on 14May2021 12:00, the day following the vaccine. Two days after her second vaccine shot (15May2021), she presented with a rash on her right facial cheek and chest. Her right ear was also red and the patient complained of having an "itchy tongue." A few hours later, the patient reported that the pain was getting worse. RN did full assessment and found that the patient's rash had become worse on her ear and that the patient's speech was slurred. Vital signs were obtained and WNL (May2021). Patient not experiencing any respiratory distress. Patient send to ED to evaluate for adverse reaction. Patient returned later that evening. Adverse event resulted in emergency room/department or urgent care. The treatment included acetaminophen and diphenhydramine. The patient was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported serious unlisted event namely "Pain" cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus was intermittent after first dose.  Then consistent after second dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: el9265), via an unspecified route of administration, administered in left arm on 12Feb2021 at 08:00 (at the age of 63-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included high blood pressure, ankolosing spondylitis. The concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE), metoprolol (METOPROLOL) and Silva sala one 50 mg. The patient was not pregnant at the time of vaccination. 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 not been tested with covid-19. On 21Feb2021 at 09:00, the patient experienced tinnitus was intermittent after first dose. then consistent after second dose. No therapeutic measures were taken as a result of event. The outcome of the event was reported as not resolved.   Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Loss of consciousness, Pain in extremity, Weight
Clinical narrative: Passed out; arm hurt; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration administered in arm right on 24Jul2021 (Batch/Lot number was not reported) at age of 86-year-old as single dose for covid-19 immunisation. Medical history included eye problem (The only thing she has wrong is with her eyes.   She has to see her eye doctor real often, not very often, just once in a while), ongoing dyspnoea, ongoing insomnia, ongoing hypersensitivity. No family medical history relevant to AE. Concomitant medications included ongoing lisinopril taking for a long time; ongoing vitamin e; ongoing ascorbic acid (VITAMIN C); ongoing calcium; ongoing cetirizine hydrochloride (EQUATE ALLERGY RELIEF) taken for hypersensitivity; ongoing biotin; ongoing vitamin d3; ongoing melatonin taken for sleep disorder; ongoing fexofenadine hydrochloride (ALLEGRA); fluticasone propionate taken for eye disorder; ongoing umeclidinium bromide, vilanterol trifenatate (ANORO) taken for dyspnoea.  The patient previously took 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 3 weeks prior to the second dose in Jul2021 given late in the afternoon in the left arm at age of 86 years as single dose for covid-19 immunisation. No Additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). No AEs following prior vaccinations. The patient experienced arm hurt on 24Jul2021, passed out on 25Jul2021.  The patient was calling regarding the Pfizer shot, she got 2 shots. She got the second Pfizer in the early afternoon, stated that it one they give for Covid. This was the problem, the first one she got, didn't bother her at all. The second one made her arm hurt but, she took a pill that was given to her. That was on Saturday. on Sunday, she went to church and she felt all right but then, she passed out and when she came to, her pastor and and his son and wife were all around her.  There were a lot of people around her.  Everybody was around her holding her up. Clarified that it was Sunday 25Jul2021 that she passed out at church. It was about noon. Everyone was holding her up and praying for her. She had no idea how long she was out. It truly wasn't very long. The pain in the arm, she was still sort of feeling but not all of it.  Treatment: She took one pill that was provided to her from the pharmacy. Did not know what it was. She now had no pain the arm, what so ever. The events did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included body height: about 5 foot 2 or 3, weight: 122 or 124 lbs (something like that).  Therapeutic measures were taken as a result of arm hurt. The outcome of event passed out was recovered on 25Jul2021. The outcome of event arm hurt was recovered in Jul2021.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Shortness of breath; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FA6780), via an unspecified route of administration, administered in Arm Left, on 26Jul2021 13:00 (at the age of 20-years-old, not pregnant) at single dose, for covid-19 immunisation. There were no medical history and concomitant medications. Patient had no COVID prior vaccination, had no known allergies, had no other medical history. Patient did not have COVID tested post vaccination. No other vaccine in four weeks. No other medications in two weeks. On 27Jul2021 18:00, the patient experienced shortness of breath, and increased heart rate. The patient underwent lab tests and procedures which included heart rate increased on 27Jul2021. The outcome of events was unknown. No treatment received.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: had anaphylaxis; This is a spontaneous report from a non-contactable other health professional. An adult female patient of unspecified age (reported as "18-24 years old") received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took flu shot and was allergic to the vaccine. The patient had anaphylaxis to her first shot on an unspecified date. The patient ended up in the hospital. Therapeutic measures were taken as a result of "anaphylaxis" included EPIPEN. The outcome of event was unknown.   No follow up attempts are possible. Information about lot/batch number cannot be requested. Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of anaphylaxis due to temporal relationship, and current known drug safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Arthritis, Oedema peripheral, Osteoporosis
Clinical narrative: Osteoporosis.; lower leg edema; anemia; arthritis of my left knee; This is a spontaneous report from a contactable consumer(patient). A 80-Year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Feb2021 as a single dose for COVID-19 immunisation. On an unspecified date, the patient experienced Osteoporosis, lower leg edema, anemia, arthritis of my left knee. On 09Mar She had a treatment for Osteoporosis. The treatment She had was an infusion called 'Reclast' which is zolodronic acid. On 11Mar, she had a second Pfizer Covid-19 vaccination. Within two days She began to have a serious negative reaction to the 'Reclast'. She had lower leg edema and then anemia. A hospital stays and tests indicated no other cause for the anemia. She also had the reversal of what had been an effective treatment for arthritis of my left knee. It was reported that Because of those negative reactions to the 'Reclast', I am wondering if the zolodronic acid could have injured the effectiveness of my vaccination shots. I have been wearing a mask when I go into stores or places where I do not know that the people have been vaccinated. I am very appreciative of all your company has done to help people in this country and the world get protected against Covid-19. I wonder whether or not my vaccination protection has been injured by the zolodronic acid. If you think it could have compromised my protection, should I have a booster or a repeat of the original series? I could only do that with specific permission from your company. I hope you will take my concern seriously and reply to my letter.The outcome of the events was unknown.  Information about lot/batch number has been requested
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Skin wrinkling, Swelling, Urticaria
Clinical narrative: face/neck rash; face/neck hives; swelling; Wrinkled; This is a spontaneous report from a contactable consumer (the patient).     A 44-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10May2021 (Batch/Lot number was not reported) as single dose  for covid-19 immunisation  .  Medical history included Crohn's disease, pyoderma gangrenosum . Concomitant medications included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported.  On 19Apr2021 the patient received the first dose of BNT162B2 and experienced rash and urticaria. The patient previously took remicade and experienced drug hypersensitivity.  The patient experienced face/neck rash (medically significant) on May2021 with outcome of unknown , face/neck hives  (medically significant) on May2021 with outcome of unknown , swelling  (medically significant) on May2021 with outcome of unknown , was wrinkled  (medically significant) on May2021 with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 07Jul2021  .   Therapeutic measures were taken as a result of face/neck rash and included unknown cream for the rash.  Course of the event. One week after I got my first vaccine show on 19Apr2021, and the day after I did my Humira injection, the left side of my face and neck broke out in a rash/hives. It was milder the first shot and resolved in about of week. The second shot I received 10May2021 and again a week later, face/neck rash/hives swelling, primarily on left side. Looks similar to a burn almost, dry and wrinkled.  The second shot made the rash significantly worse and I went to my dermatologist for some creams that helped. Now every time I take my Humira injection it reflares up. It is continuing still, however lessens in severity with each week.  Information on lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Migraine
Clinical narrative: severe headache/migraine; severe headache/migraine; nausea; diarrhea; sore/achy muscles; weakness; chills; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jul2021 08:00 (Batch/Lot Number: EW0191) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); lamotrigine (LAMICTAL); gabapentin all taken for an unspecified indication, start and stop date were not reported. On 21Jul2021 12:00, the patient experienced severe headache/migraine, nausea, diarrhea, sore/achy muscles, weakness and chills. The patient did not received treatment for the events. The outcome of the events recovered on unspecified date in Jul2021.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: severe headache/migraine; severe headache/migraine; nausea; diarrhea; sore/achy muscles; weakness; chills; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jul2021 08:00 (Batch/Lot Number: EW0191) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); lamotrigine (LAMICTAL); gabapentin all taken for an unspecified indication, start and stop date were not reported. On 21Jul2021 12:00, the patient experienced severe headache/migraine, nausea, diarrhea, sore/achy muscles, weakness and chills. The patient did not received treatment for the events. The outcome of the events recovered on unspecified date in Jul2021.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: poison ivy; Itching; Hives; Redness/redness on her skin; Nausea; feeling faint; felt faint and dizzy /lightheaded; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, manufacturer: Pfizer) at 70-year-old, dose 1 via an unspecified route of administration, administered in Arm Right on 19Jul2021 13:37 (Batch/Lot Number: EKC0177; Expiration Date: 31Aug2021) as dose 1, single for covid-19 immunisation In Physician Office. Medical history and concomitant medications were none.  History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. none other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AE(s) following prior vaccinations was None. Family had cancer and heart disease. Caller is a consumer that was calling about the Covid-19 vaccine and reported that she took her first dose on 19Jul2021. She said that she was calling about the adverse reactions. Caller reported that she felt faint and dizzy immediately after taking the first dose and that went on for 6 hours. She had to lay down. Several days later (21Jul2021) she developed itching, hives, and redness on her skin. She is using Caladryl. She thought she had poison ivy. The cream her doctor prescribed was for poison ivy, but was not working. Caller said that the Caladryl was helping. Caller said that she felt a little nausea the first day but that quickly passed. The caller said that she took the vaccine at the doctor's office. The caller said that the feeling faint and dizzy passed after 6 hours. She was lightheaded at the office, but she was able to drive home, but it got worse after she got home, the whole room was spinning. She took 2 Aleve and laid down and took a nap.  The caller said that the itching hives and redness was on her arms and her face. She washed herself in hot water and put the Caladryl on to treat it and the itchiness is improved, but is still there. Second dose is due on 11Aug2021. She said that no one she spoke with said that they had reaction to the first shot and everyone said that they had reactions to the second shot. She said that it threw her for a loop as she had reactions to the first shot. She hopes the second shot is better. Caller asked if her side effects were normal. Caller then looked at the information from her doctor's office and said that she answered her own question. She has a list of side effects that she got from the doctors office. They are on the list that she has from the doctor's office. Poison Ivy Cream was Triamcinolone Acetonide (NDC: 0713-0225-80, Lot: 11-22580GW4, Expiry: Jun2018, also reported Lot: 1012774, Expiry: Feb2022). Event were not required a visit to Emergency Room nor Physician Office. Relevant Tests was None. Outcome of faint and dizzy, Nausea were all recovered on 19Jul2021. Outcome of other events was recovering.