chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cardiac function test, Dizziness, Electroencephalogram, Headache, Magnetic resonance imaging
Clinical narrative: headaches; he was dizzy; This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID--19 VACCINE, Lot number was not reported), via an unspecified route of administration on Jan2021 as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got Pfizer-BioNTech Covid-19 vaccine in Jan2021. He haven't had any problems, until about 2 months ago (2021). The patient started having headaches and he was dizzy. He has had an MRI, EEG, wore a heart monitor, and a carotid artery check and they can't find anything wrong. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: headaches; he was dizzy; This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID--19 VACCINE, Lot number was not reported), via an unspecified route of administration on Jan2021 as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got Pfizer-BioNTech Covid-19 vaccine in Jan2021. He haven't had any problems, until about 2 months ago (2021). The patient started having headaches and he was dizzy. He has had an MRI, EEG, wore a heart monitor, and a carotid artery check and they can't find anything wrong. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: passed out several times and vomits; passed out several times and vomits; This is a spontaneous report from a non-contactable consumer. This consumer reported similar event for two patients. This the second of two reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) dose number was unknown, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that their neighbor's boyfriend (patient) had passed out several times and vomits. The reporter asked if there was a clinical trial to study these side effects. Outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100956275 Same reporter, same drug and event, different patient
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain injury, Hyperhidrosis, Loss of personal independence in daily activities, Myocardial infarction, Pain
Clinical narrative: transient ischemic attack; classic symptoms of a heart attack; she thinks it has effected her brain; radiating pain; sweating; could not get up and drive her car; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Mar2021 (72-years-old at the time of vaccination) (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included trigeminal nerve from an unknown date and unknown if ongoing. Concomitant medication included lamotrigine (LAMICTAL) : taking about 2 years taken for trigeminal nerve disorder, start and stop date were not reported. Patient received both doses of the vaccine on 01Mar2021 and 29Mar2021 and was hospitalized for heart attack symptoms(13Jul2021), but the patient was thinking it was not a heart attack. Patient Stated that she did not have any follow up appointments until 12Aug2021, caller stated she thinks it was more of a TIA, clarified trans ischemic attack, than an MI, so she was just checking . Patient Stated that the intense pain lasted 5-10 minutes, then had classic symptoms of a heart attack, clarified the radiating pain and sweating, lasted about 25-30 minutes, stated she was actually at a bible study when it happened, could not get up, could not get up and drive her car, by the end of the session went home and took an aspirin and a nap, at 6PM she went to MedExpress and they sent her to the hospital and she was admitted because of the symptoms she experienced. She was hospitalized for 3 days (13Jul2021 to 15Jul2021) with classic symptoms of a heart attack after the vaccines, but it was not panning out. She had not completely recovered, she thought it had affected her brain, took medication for trigeminal nerve problem, wondering if it could had disrupted that somehow. Stated she did not have any follow up appointments until 12Aug2021, caller stated she thinks it was more of a TIA, clarified trans ischemic attack, than an MI, so she was just checking. The reported seriousness of the event was hospitalization. The clinical outcome of the event transient ischemic attack,classic symptoms of a heart attack was not recovered, remaining all other events was unknown at the time of report.  Information about lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: transient ischemic attack; classic symptoms of a heart attack; she thinks it has effected her brain; radiating pain; sweating; could not get up and drive her car; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Mar2021 (72-years-old at the time of vaccination) (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included trigeminal nerve from an unknown date and unknown if ongoing. Concomitant medication included lamotrigine (LAMICTAL) : taking about 2 years taken for trigeminal nerve disorder, start and stop date were not reported. Patient received both doses of the vaccine on 01Mar2021 and 29Mar2021 and was hospitalized for heart attack symptoms(13Jul2021), but the patient was thinking it was not a heart attack. Patient Stated that she did not have any follow up appointments until 12Aug2021, caller stated she thinks it was more of a TIA, clarified trans ischemic attack, than an MI, so she was just checking . Patient Stated that the intense pain lasted 5-10 minutes, then had classic symptoms of a heart attack, clarified the radiating pain and sweating, lasted about 25-30 minutes, stated she was actually at a bible study when it happened, could not get up, could not get up and drive her car, by the end of the session went home and took an aspirin and a nap, at 6PM she went to MedExpress and they sent her to the hospital and she was admitted because of the symptoms she experienced. She was hospitalized for 3 days (13Jul2021 to 15Jul2021) with classic symptoms of a heart attack after the vaccines, but it was not panning out. She had not completely recovered, she thought it had affected her brain, took medication for trigeminal nerve problem, wondering if it could had disrupted that somehow. Stated she did not have any follow up appointments until 12Aug2021, caller stated she thinks it was more of a TIA, clarified trans ischemic attack, than an MI, so she was just checking. The reported seriousness of the event was hospitalization. The clinical outcome of the event transient ischemic attack,classic symptoms of a heart attack was not recovered, remaining all other events was unknown at the time of report.  Information about lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Hair colour changes, Hair disorder, Investigation, Metabolic function test
Clinical narrative: transient ischemic attack; classic symptoms of a heart attack; she thinks it has effected her brain; radiating pain; sweating; could not get up and drive her car; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Mar2021 (72-years-old at the time of vaccination) (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included trigeminal nerve from an unknown date and unknown if ongoing. Concomitant medication included lamotrigine (LAMICTAL) : taking about 2 years taken for trigeminal nerve disorder, start and stop date were not reported. Patient received both doses of the vaccine on 01Mar2021 and 29Mar2021 and was hospitalized for heart attack symptoms(13Jul2021), but the patient was thinking it was not a heart attack. Patient Stated that she did not have any follow up appointments until 12Aug2021, caller stated she thinks it was more of a TIA, clarified trans ischemic attack, than an MI, so she was just checking . Patient Stated that the intense pain lasted 5-10 minutes, then had classic symptoms of a heart attack, clarified the radiating pain and sweating, lasted about 25-30 minutes, stated she was actually at a bible study when it happened, could not get up, could not get up and drive her car, by the end of the session went home and took an aspirin and a nap, at 6PM she went to MedExpress and they sent her to the hospital and she was admitted because of the symptoms she experienced. She was hospitalized for 3 days (13Jul2021 to 15Jul2021) with classic symptoms of a heart attack after the vaccines, but it was not panning out. She had not completely recovered, she thought it had affected her brain, took medication for trigeminal nerve problem, wondering if it could had disrupted that somehow. Stated she did not have any follow up appointments until 12Aug2021, caller stated she thinks it was more of a TIA, clarified trans ischemic attack, than an MI, so she was just checking. The reported seriousness of the event was hospitalization. The clinical outcome of the event transient ischemic attack,classic symptoms of a heart attack was not recovered, remaining all other events was unknown at the time of report.  Information about lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Inappropriate schedule of product administration, Neuropathy peripheral, Pain
Clinical narrative: now both legs are acting like I have peripheral neuropathy; I got the second shot almost 8 weeks later; having a hard time just walking; very painful; This is a spontaneous report from a contactable consumer or other non hcp.   A 70-year-old male patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on 2021 as dose 2, single (Age at Vaccination:70) for covid-19 immunisation. He received bnt162b2 (BNT162B2, Batch/Lot number: EW0176) via an unspecified route of administration, administered in right arm on 3May2021 at 10:00 AM as dose 1 single, for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing if covid prior vaccination: Yes, drug hypersensitivity from an unknown date and unknown if ongoing known allergies as Penicillin. Concomitant medication included finasteride (5mg daily) and metoprolol (25mg daily). Prior to vaccination, patient was diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 2021, The patient reported now his both legs were acting like i had peripheral neuropathy, got the second shot almost 8 weeks late, had a hard time just walking, very painful. After received the first shot, On 06May2021 at 01:00AM he started had a pain in my right calf and hamstring muscle. Like a pulled muscle. He had not been doing any heavy exercise other than walking. It was hard to walk because his right leg felt heavy. He got second shot almost 8 weeks later and now both legs was acting like he had peripheral Neuropathy. He was having a hard time just walking and it was very painful. He received treatment for the adverse event (testing pending). The outcome of the events were not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Limb discomfort, Muscle strain, Pain in extremity
Clinical narrative: now both legs are acting like I have peripheral neuropathy; I got the second shot almost 8 weeks later; having a hard time just walking; very painful; This is a spontaneous report from a contactable consumer or other non hcp.   A 70-year-old male patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on 2021 as dose 2, single (Age at Vaccination:70) for covid-19 immunisation. He received bnt162b2 (BNT162B2, Batch/Lot number: EW0176) via an unspecified route of administration, administered in right arm on 3May2021 at 10:00 AM as dose 1 single, for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing if covid prior vaccination: Yes, drug hypersensitivity from an unknown date and unknown if ongoing known allergies as Penicillin. Concomitant medication included finasteride (5mg daily) and metoprolol (25mg daily). Prior to vaccination, patient was diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 2021, The patient reported now his both legs were acting like i had peripheral neuropathy, got the second shot almost 8 weeks late, had a hard time just walking, very painful. After received the first shot, On 06May2021 at 01:00AM he started had a pain in my right calf and hamstring muscle. Like a pulled muscle. He had not been doing any heavy exercise other than walking. It was hard to walk because his right leg felt heavy. He got second shot almost 8 weeks later and now both legs was acting like he had peripheral Neuropathy. He was having a hard time just walking and it was very painful. He received treatment for the adverse event (testing pending). The outcome of the events were not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: vaccine only serves half despite having the two doses, it gave me covid; vaccine only serves half despite having the two doses, it gave me covid; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (Patient) reported that a patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACUBE, Solution for injection), dose 2 and dose 1, both via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported vaccine only served half despite having the two doses, it gave covid and patient was screwed at home. The outcome of events was unknown.   Information about lot/batch has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Pruritus, Rash, Urticaria
Clinical narrative: When she scratches the rash, it results to bleeding; Hives (not in patches but randomly all over leg and arm)/Rash and hives all over; Itching; Rash; This is a spontaneous report received from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 44-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- ER8729) via an unspecified route of administration in right arm on 27Jul2021 14:30 as dose 1, single (at the age of 44-years-old) for COVID-19 immunization. Vaccination facility type was reported as Clinic. The COVID-19 vaccine was administered to patient in military facility. Patient medical history included ongoing type 2 diabetes mellitus and ongoing hypothyroidism both of which were diagnosed 5 years ago. The concomitant medications included metformin,  strength 1000 mg, taken for type 2 diabetes mellitus (Type II Diabetes) at a dose and frequency of 1000 mg, 2x/day with a daily dosing of 2000 mg from an unspecified start date and ongoing. The patient experienced when she scratched the rash, it resulted to bleeding, hives, itching and rash on 27Jul2021 19:00/20:00. Event onset dates for rash and hives all over was 27Jul2021. The event seriousness was reported to be unspecified. She clarified it was the COVID Vaccine. She stated was wondering if there was anything reported about a rash, hives all over. She got the shot yesterday. She got the shot about 14:30. The rash and hives started yesterday evening. By 19:00/20:00, patient legs were itching like rash and hives and it gradually went up to her knees and back of her legs. The rash and hives were like random spots. Then last night it started moving on her arms. Patient stated that she was taking Benadryl to keep from scratching skin off. She confirmed that she took her first dose of vaccine. While attempting to capture details, caller started speaking to someone in the background and difficult to hear/understand conversation with individual in background. Patient then came back to line and stated that her youngest son was mentioning about his own itching issue after receiving the COVID vaccine. She commented her vaccination card has the lot details, but the other ones do not. The adverse events did not result in physician or emergency room visit. Therapeutic measures were taken as a result of when she scratches the rash it results to bleeding, hives and itching. The outcome of the events was not recovered.  Follow up (28Jul2021): This is a follow up spontaneous report received from a contactable consumer or other non-HCP (patient herself) and included event onset date details, unspecified reporter seriousness, adverse event details, confirmation on her vaccine dose number, information that the COVID-19 vaccine was administered at a military facility, prior vaccination details and details that the adverse events did not result in physician office or emergency room visit as was merged and processed with the initial narrative.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Cognitive disorder, Constipation, Dizziness, Dysarthria
Clinical narrative: Postural orthostatic tachycardia syndrome; kept passing out; Constipation; Blurred vision; loss of words; in a wheelchair; Memory loss; Slurred speech; major fatigue; Headache; Fever chills; extreme dizziness; This is a spontaneous report from a contactable consumer (patient's mother-in-law).   A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on an unspecified date in 2021 as single dose for covid-19 immunization (at the age of 39-year-old). The patient medical history was not reported. The patient's concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date for covid-19 immunization (at the age of 39-year-old). The patient hospitalized for postural orthostatic tachycardia syndrome for 7 days between 24May2021 to 28May2021, kept passing out from May2021 to Jun2021. On an unspecified date in May2021, the patient experienced in a wheelchair and loss of words. He started to have memory loss and slurred speech around the same time of 24May2021 to 28May2021. Her son in law started wearing a helmet when he was released from the hospital. He also started using a wheelchair at that time. He was very weak and dizzy. In order to avoid accidents he was given a prescription for a wheelchair. Her son in law was perfectly healthy prior to this. He also had fever and chills like everyone does. Her son in law had a battery of test at the hospital to rule out any other possible cause. Results are unavailable at this time. Her daughter had the vaccine at the same time and was fine. On an unspecified date in 2021, the patient experienced extreme dizziness, major fatigue, headache, fever chills. On an unspecified date, blurred vision and constipation. The outcome of all the events was not recovered.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Loss of consciousness, Postural orthostatic tachycardia syndrome, Pyrexia
Clinical narrative: Postural orthostatic tachycardia syndrome; kept passing out; Constipation; Blurred vision; loss of words; in a wheelchair; Memory loss; Slurred speech; major fatigue; Headache; Fever chills; extreme dizziness; This is a spontaneous report from a contactable consumer (patient's mother-in-law).   A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on an unspecified date in 2021 as single dose for covid-19 immunization (at the age of 39-year-old). The patient medical history was not reported. The patient's concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date for covid-19 immunization (at the age of 39-year-old). The patient hospitalized for postural orthostatic tachycardia syndrome for 7 days between 24May2021 to 28May2021, kept passing out from May2021 to Jun2021. On an unspecified date in May2021, the patient experienced in a wheelchair and loss of words. He started to have memory loss and slurred speech around the same time of 24May2021 to 28May2021. Her son in law started wearing a helmet when he was released from the hospital. He also started using a wheelchair at that time. He was very weak and dizzy. In order to avoid accidents he was given a prescription for a wheelchair. Her son in law was perfectly healthy prior to this. He also had fever and chills like everyone does. Her son in law had a battery of test at the hospital to rule out any other possible cause. Results are unavailable at this time. Her daughter had the vaccine at the same time and was fine. On an unspecified date in 2021, the patient experienced extreme dizziness, major fatigue, headache, fever chills. On an unspecified date, blurred vision and constipation. The outcome of all the events was not recovered.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Wheelchair user
Clinical narrative: Postural orthostatic tachycardia syndrome; kept passing out; Constipation; Blurred vision; loss of words; in a wheelchair; Memory loss; Slurred speech; major fatigue; Headache; Fever chills; extreme dizziness; This is a spontaneous report from a contactable consumer (patient's mother-in-law).   A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on an unspecified date in 2021 as single dose for covid-19 immunization (at the age of 39-year-old). The patient medical history was not reported. The patient's concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date for covid-19 immunization (at the age of 39-year-old). The patient hospitalized for postural orthostatic tachycardia syndrome for 7 days between 24May2021 to 28May2021, kept passing out from May2021 to Jun2021. On an unspecified date in May2021, the patient experienced in a wheelchair and loss of words. He started to have memory loss and slurred speech around the same time of 24May2021 to 28May2021. Her son in law started wearing a helmet when he was released from the hospital. He also started using a wheelchair at that time. He was very weak and dizzy. In order to avoid accidents he was given a prescription for a wheelchair. Her son in law was perfectly healthy prior to this. He also had fever and chills like everyone does. Her son in law had a battery of test at the hospital to rule out any other possible cause. Results are unavailable at this time. Her daughter had the vaccine at the same time and was fine. On an unspecified date in 2021, the patient experienced extreme dizziness, major fatigue, headache, fever chills. On an unspecified date, blurred vision and constipation. The outcome of all the events was not recovered.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: continual reduction in platelets.; This is a spontaneous report from a contactable consumer (Patient's niece). This consumer reported for a 76-Year-old-male (Patient) that.  A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: el9264), dose 1 intramuscular, administered in Arm Right on 29Jan2021 as (at the age of 76-years) DOSE 1, SINGLE, dose 2 intramuscular, administered in Arm Right on 24Feb2021 (Lot Number: en6198) as (at the age of 76-years-old) DOSE 2, SINGLE for covid-19 immunisation. Medical history included, immune thrombocytopenia from an unknown date and unknown if ongoing (verbatim: Idiopathic thombocytopenia purpura), prostatomegaly from an unknown date and unknown if ongoing (verbatim: enlarged prostate). Concomitant medication (received within 2 weeks of vaccination) included finasteride 5 MG, and plantago ovata (METAMUCIL [PLANTAGO OVATA]) all wares taken for an unspecified indication, start and stop date were not reported. The patient previously took tetracycline and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not test for COVID-19 since the vaccination. The patient experienced continual reduction in platelets on 01Apr2021. As a result of event patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care . Patient received Prednisone 60 MG as treatment for event. The patient underwent lab tests and procedures which included platelet count: decreased on 01Apr2021 Continual reduction in platelets. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: My menstrual cycle has been off since I got my first vaccine; This is a spontaneous report from a contactable consumer reported for herself.   A 22-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 22Apr2021 08:00 AM (at the age of 22-years-old), as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history, concomitant or other medications in two weeks, other vaccine in four weeks included none. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced her menstrual cycle had been off since she got first vaccine. It was stated that her menstrual cycle has been off since she got first vaccine, but she didn't really notice it until after her second. There were 50 days between her cycle in May and June, and then another 35 days between June and July. Her cycle has been notably worse as well, heavier bleeding and cramping as well as getting migraines frequently when on her period. Serious criteria included none and the event was not serious. No treatment received for the event. Clinical outcome of the event was not recovered.  Information on lot/batch number was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Took the first shot, her throat closed up; This is a spontaneous report from a contactable consumer (husband).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the first shot, her throat closed up on an unspecified date. Patient took 2 Benadryl, and it went away. Patient was recommended to go to the ER, she didn't want to go, went home and was recommended take 2 Benadryl, and that took care of her problem. Patient also took 2 Benadryl before with the second, and that eliminated her throat closing down. Reporter did not want to go through a report for patient, as patient was ok at the time of this report, it was no problem, but he thought to mention, as it might be a problem with the batch, she was ok and had no repercussions. Therapeutic measures were taken as a result of the event. Reason for no lot number of Pfizer COVID vaccine stated as caller unwilling to complete the report. Outcome for the event was recovered on an unspecified date.  Lot number for the vaccine (BNT162B2), was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID positive diagnosis 28Jul2021; COVID positive diagnosis 28Jul2021; This is a spontaneous report from a contactable consumer. A 62-years-old female consumer (patient) reported for herself.  A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection.), dose 1 via an unspecified route of administration, administered in left arm on 04Mar2021 at 12:00 (Lot number: unknown) as dose 1, single, dose 2 via an unspecified route of administration, administered in right arm on 25Mar2021 at 10:45 (Lot number: unknown) as dose 2, single for COVID-19 immunization (at the age of 62-years-old). Medical history included moderate to severe atopic dermatitis. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. Patient had no COVID-19 prior vaccination. Patient had no known allergies. Concomitant medication included acetylsalicylic acid (BAYER ASPIRIN) in two weeks. The patient experienced COVID-19 positive diagnosis on 28Jul2021. Adverse event start on 22Jul2021 at 01:45 PM. Seriousness criteria-results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect all reported as no. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on post vaccination on 28Jul2021. Adverse event resulted in, Doctor or other health care professional office/clinic visit. Adverse event treatment include Medrol dosepak. The outcome of the event COVID positive diagnosis 28Jul2021 (covid-19) was not recovered and unknown for another event.  Information about lot/batch number cannot be obtained. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: fast heart beat; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2 solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced fast heart beat on an unspecified date. The patient underwent lab tests and procedures which included heart rate: fast on unspecified date. The historical vaccine include BNT162B2 (DOSE:1) for COVID-19 Immunization. Reported as I had a fast heart beat on the first dose and I had that reaction for two days after I had the vaccine. Now the other person that I know that person said that he has the same reaction but it was on the second dose and I wanted to let you know that person I don't think is going to report it. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: lower back pain/dense pain; reported arm pain after receiving the Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 28Jul2021 as dose number unknown, single for COVID-19 immunization. Medical history included kidney infection. Caller reported a previous kidney infection. Was started on Bactrim (sulfamethoxazole). The patient's concomitant medications were not reported. The patient previously took sulfamethoxazole. Other Products were not provided. The patient experienced kidney infection (medically significant) and lower back pain/dense pain on an unspecified date in Jul2021. It was reported that, patient received her Pfizer Covid 19 Vaccine on 28Jul2021. She was feeling fine. She now had lower back pain. Caller reported a previous kidney infection. Was started on Bactrim (sulfamethoxazole). Patient enquired if she should contact her HCP or if the symptom might be related to the vaccine. Patient enquired if it was okay to take the Bactrim (sulfamethoxazole). Caller reported arm pain after receiving the Pfizer Covid 19 Vaccine and asked what's the time span that side effects were reported. Report was not related to a study or programme. Patient reported that, she got the shot yesterday and was feeling fine and asked if this was something she should look out for or if she should contact her HCP and her lower back had a dense pain. Therapeutic measures were taken as a result of kidney infection. The outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death, SARS-CoV-2 antibody test
Clinical narrative: passed away; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as single dose, and dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. As reported, caller was a patient who stated he and his wife received the Pfizer COVID vaccine, and were vaccinated in Jan2021 and Feb2021. Caller was inquiring about the antibody testing, as he and his wife had one done. Caller wanted to know why he and his wife tested negative for antibodies. Caller was concerned because his sister who had both the Pfizer COVID vaccine shots passed away and she showed not having any antibodies. The patient died on an unspecified date.  An autopsy was not performed.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
Sex: U
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: last time my left eye is all kind of red; This is a spontaneous report from a contactable consumer. This consumer (Patient) reported for self. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced last time my left eye is all kind of red on an unspecified date in 2021. It was reported that, patient got second Covid shot yesterday last time and patients left eye was all kind of red and so this morning patient woke up kind of crested, patient never had pinkeye before and did not know if it was pinkeye was it something might be having a shot patient would get. Patient just wanted to talk to someone if it was a side effect it was Saturday doctor's office was not open. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Eye pain, Fatigue
Clinical narrative: Covid-19; Covid-19; Eye pain; Headache; Fatigue; Weakness; Sore throat; Stuffy nose; Cough; This is a spontaneous report from a contactable consumer (patient reported for herself). 26-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an intramuscular route of administration, administered in Arm Left on 19Feb2021 (at the age of 26-year-old) (Lot Number: EL9266) as DOSE 1, SINGLE and dose 2 via an intramuscular route of administration, administered in Arm Left on 12Mar2021 (at the age of 26-year-old) (Lot Number: EN6206) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jul2021, the patient experienced Covid-19, Headache, Fatigue, Weakness, Sore throat, Stuffy nose, Cough, and Eye pain. On 29Jul2021, post vaccination, the patient underwent SARS-CoV- 2 rapid ag (Nasal Swab) test, which was positive for covid-19. Patient received treatment with Tylenol to treat the events. The outcome of all the events was not resolved at the time of this report.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal obstruction, Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; Eye pain; Headache; Fatigue; Weakness; Sore throat; Stuffy nose; Cough; This is a spontaneous report from a contactable consumer (patient reported for herself). 26-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an intramuscular route of administration, administered in Arm Left on 19Feb2021 (at the age of 26-year-old) (Lot Number: EL9266) as DOSE 1, SINGLE and dose 2 via an intramuscular route of administration, administered in Arm Left on 12Mar2021 (at the age of 26-year-old) (Lot Number: EN6206) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jul2021, the patient experienced Covid-19, Headache, Fatigue, Weakness, Sore throat, Stuffy nose, Cough, and Eye pain. On 29Jul2021, post vaccination, the patient underwent SARS-CoV- 2 rapid ag (Nasal Swab) test, which was positive for covid-19. Patient received treatment with Tylenol to treat the events. The outcome of all the events was not resolved at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tachycardia, Thyroiditis subacute
Clinical narrative: Thyroiditis subacute; Lymphadenopathy; Tachycardia; This is a spontaneous report from a non-contactable consumer. A 41-years-old female patient received first dose of bnt162b2 (FIZER-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 in 2021 (at age of 41-years old) as dose1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced thyroiditis subacute, lymphadenopathy, tachycardia. It was reported that calculated time to onset (TTO) was 14 days. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: developed breakthrough covid infection in april which necessitated monoclonal antibody infusion; developed breakthrough covid infection in april which necessitated monoclonal antibody infusion; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), Lot number- EL0140) via an unspecified route of administration in left arm on 20Dec2020 as dose 1 single and received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), Lot number: EK9231) via an unspecified route of administration in left arm on 10Jan2021 as dose 2 single for COVID-19 immunization. Patient age at vaccination was 60 Years. Medical history included hypertension, hypercholesterolemia, know allergies: sulfa. Concomitant medications within 2 weeks of vaccination included rosuvastatin calcium (CRESTOR), lisinopril, Indapamide, vitamins. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Apr2021, the patient developed breakthrough COVID infection in April which necessitated monoclonal antibody infusion. Adverse event resulted in Emergency room/department or urgent care. Patient received treatment with monoclonal antibody infusion. Since the vaccination, the patient had been tested for COVID-19 PCR test via Nasal Swab resulted positive on 24Apr2021. The outcome of the events was recovered on an unspecified date in 2021.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of vaccination failure and COVID-19 cannot be totally excluded/assessed.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: her heart was going fast; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on 28Jul2021 (at the age of 13-year-old), as a single for COVID-19 immunization. No medical history and concomitant medications were reported. No investigation assessment. On 29Jul2021, her heart was going fast. It was reported that, mother calling on behalf of daughter, aged 13-year-old, received first dose of the Pfizer BioNTech Covid 19 vaccine on 28Jul2021. That evening in the middle of the night when she got home, her daughter was crying because she said her heart was going fast, similar to if she had just been exercising. Her daughter told her that she's not in pain but still having these symptoms of a fast heartbeat now. She tried calling the doctor but was unable to make an appointment. The patient took Pfizer COVID-19 vaccine "They want to prevent getting sick from school". No product quality complaints were reported. The outcome of the event was not resolved.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Fibrin D dimer increased, Vertigo
Clinical narrative: D-dimer drawn 40 minutes after shot (for APLS unrelated to shot) was elevated at D dimer (value 0.62 mcg/ml feu); Had to extreme vertigo 17 minutes after vaccine that lasted 30 minutes.; This is a spontaneous report from a contactable other health professional (patient). A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 28Jul2021 at 16:00 (Lot Number: FA6780) (at the age of 37-year-old) as single dose for COVID-19 immunisation.  Medical history included antiphospholipid syndrome (APLS), blood pressure (BP) high, obesity, possible multiple sclerosis (MS), all from an unknown date and unknown if ongoing. No known allergies. The patient did not experienced COVID-19 prior or post vaccination. Concomitant medications included apixaban (ELIQUIS); metoprolol; gabapentin and omeprazole, all concomitants were taken for an unspecified indication, start and stop date were not reported.  On 28Jul2021, the patient experienced D-dimer drawn 40 minutes after shot (for APLS unrelated to shot) was elevated at D dimer (value 0.62 mcg/ml feu) and extreme vertigo 17 minutes after vaccine that lasted 30 minutes. The events were reported as serious, life threatening.  The patient underwent lab tests and procedures which included fibrin D dimer: 0.44 ug/ml on 08Jul2021 and 0.62 ug/ml on 28Jul2021 (Standard Range <0.50 mcg/mL FEU). No therapeutic measures were taken as a result of the events. The patient outcome of the events was recovering.; Sender's Comments: Based on possible temporal association and known safety profile,the causal role of BNT162B2 cannot be excluded for reported adverse events.  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