chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gastrointestinal disorder, Headache, Malaise, Pyrexia
Clinical narrative: generalized not feeling well, some GI complaints, bad joint pain, headache and a fever; headache and a fever; GI complaints,; joint pain; headache and a fever; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: and Expiration date was unknown), via an unspecified route of administration on 26Jan2021 (at the age of 43-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient concurrent conditions included depression, anxiety, relapsing remitting multiple sclerosis, allergies (stuffy nose); all from an unknown date and are ongoing. The patient concomitant medication included ocrelizumab (OCREVUS); acetylsalicylic acid (ASPIRIN); cetirizine hydrochloride (ZYRTEC), prenatal multivitamin; all taken for an unspecified indication. The patient previously took penicillin and had allergy. On 26Jan2021, the patient had experienced generalized not feeling well, some gastrointestinal complaints, bad joint pain, headache and a fever. The outcome of events was resolved on an unspecified date in 2021.   No further information was reported.  Information about batch/ lot number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I have hives on my legs and I haven't ever had that before until I took the shot.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0185), dose 1 via an unspecified route of administration on 21Jun2021, as single dose for COVID-19 immunisation. Medical history included heart problems, thyroid problems and asthma. The patient's concomitant medications were not reported. After took first COVID shot on 22Jun2021, the patient noticed had hives on legs and she had not ever had that before until she took the shot and went to her doctor in few minutes. Patient stated this must be a side effect. The last night (22Jun2021) and took a very cold shower and iced the area with a bunch of ice and she called her doctor, doctor told to go and get over the counter medicine at any pharmacy and got Benadryl 25 mg. Therapeutic measures were taken as a result of event and treatment with Benadryl 25 mg. Outcome of the event was unknown.  Follow-up attempts are needed;further information is expected.; Sender's Comments: Linked Report(s):PFIZER INC-2021770789 Same reporter/product/event, different patients
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient got the Pfizer covid vaccine, and he experienced a sore arm.; This is a spontaneous report from a contactable consumer reported for a male patient (Reporters wifes father) that: Report 5 of 5. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported.  The patient got the Pfizer COVID vaccine, and he experienced a sore arm on an unspecified date in 2021.  The outcome of the event was unknown.    Information on batch/lot number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Cardiovascular disorder, Cerebrovascular accident, Dizziness
Clinical narrative: Thyroid or throat area was pounding; Thyroid or throat area is pounding; legs swelled up so bad; Heart rate very low; circulation issues; Felt like having a stroke; Dizzy; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Struggling to breathe/can't breathe; Weak; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 04May2021 12:00 (Batch/Lot Number: EL9269), as dose 1, single, at age 22 years old, for COVID-19 immunization, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Medical history included Hashimoto's disease, Ehlers-Danlos syndrome, and Raynaud's disease, all from unknown dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination (unspecified concomitant medications). On 07May2021 (also reported as "around day 3 or day 4"), the patient started to get dizzy. On the same day, 07May2021, the patient felt like have a stroke because she could not make thoughts. She had pitting in left leg (also reported as "pitting in left left", pending clarification), which was pale and had veins showing, and she was struggling to breathe and was weak. On 09May2021 (also reported as "about day 5"), her heart rate was very low and she noticed circulation issues. On 11May2021 (also reported as "day 7"), her legs swelled up so bad. On 14May2021 (also reported as "day 10"), the patient's thyroid or throat area was pounding. The events resulted to emergency room and physician's office visits. Treatment for the events included turmeric and aspirin which the patient took every day, multiple times a day. Blood work on an unspecified date mostly came back normal. The patient reported the events were better in two weeks. Her physician advised her to skip the second dose. However, the patient received the second dose out of "fear of missing out" on 25May2021 12:00 (Batch/Lot Number: EW0178) in the left arm. The patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate decreased, Oedema, Pallor
Clinical narrative: Thyroid or throat area was pounding; Thyroid or throat area is pounding; legs swelled up so bad; Heart rate very low; circulation issues; Felt like having a stroke; Dizzy; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Struggling to breathe/can't breathe; Weak; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 04May2021 12:00 (Batch/Lot Number: EL9269), as dose 1, single, at age 22 years old, for COVID-19 immunization, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Medical history included Hashimoto's disease, Ehlers-Danlos syndrome, and Raynaud's disease, all from unknown dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination (unspecified concomitant medications). On 07May2021 (also reported as "around day 3 or day 4"), the patient started to get dizzy. On the same day, 07May2021, the patient felt like have a stroke because she could not make thoughts. She had pitting in left leg (also reported as "pitting in left left", pending clarification), which was pale and had veins showing, and she was struggling to breathe and was weak. On 09May2021 (also reported as "about day 5"), her heart rate was very low and she noticed circulation issues. On 11May2021 (also reported as "day 7"), her legs swelled up so bad. On 14May2021 (also reported as "day 10"), the patient's thyroid or throat area was pounding. The events resulted to emergency room and physician's office visits. Treatment for the events included turmeric and aspirin which the patient took every day, multiple times a day. Blood work on an unspecified date mostly came back normal. The patient reported the events were better in two weeks. Her physician advised her to skip the second dose. However, the patient received the second dose out of "fear of missing out" on 25May2021 12:00 (Batch/Lot Number: EW0178) in the left arm. The patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Peripheral vascular disorder, Pharyngeal disorder, Thyroid disorder
Clinical narrative: Thyroid or throat area was pounding; Thyroid or throat area is pounding; legs swelled up so bad; Heart rate very low; circulation issues; Felt like having a stroke; Dizzy; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Struggling to breathe/can't breathe; Weak; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 04May2021 12:00 (Batch/Lot Number: EL9269), as dose 1, single, at age 22 years old, for COVID-19 immunization, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Medical history included Hashimoto's disease, Ehlers-Danlos syndrome, and Raynaud's disease, all from unknown dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination (unspecified concomitant medications). On 07May2021 (also reported as "around day 3 or day 4"), the patient started to get dizzy. On the same day, 07May2021, the patient felt like have a stroke because she could not make thoughts. She had pitting in left leg (also reported as "pitting in left left", pending clarification), which was pale and had veins showing, and she was struggling to breathe and was weak. On 09May2021 (also reported as "about day 5"), her heart rate was very low and she noticed circulation issues. On 11May2021 (also reported as "day 7"), her legs swelled up so bad. On 14May2021 (also reported as "day 10"), the patient's thyroid or throat area was pounding. The events resulted to emergency room and physician's office visits. Treatment for the events included turmeric and aspirin which the patient took every day, multiple times a day. Blood work on an unspecified date mostly came back normal. The patient reported the events were better in two weeks. Her physician advised her to skip the second dose. However, the patient received the second dose out of "fear of missing out" on 25May2021 12:00 (Batch/Lot Number: EW0178) in the left arm. The patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection
Clinical narrative: double kidney infections; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0185) via an unspecified route of administration, administered in left arm on 21May2021 at 14:00 (at 37 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included spine disorders fibromyalgia and allergy to sleeping pill, both from unspecified date. The patient previously took lorazepam and naproxen and experienced allergies on unspecified date. Concomitant medications included pain medications, mirtazapine and desvenlafaxine; all from unspecified date for unspecified indication. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced double kidney infections on 01Jun2021 which was medically significant. The event resulted in emergency room and physician office visit. Clinical course was reported as follows: On 01Jun2021, the patient started having flank pain. The patient thought it was a kidney stone but was diagnosed with double kidney infections (no history of kidney infection or UTI). The patient was given intravenous (IV) antibiotics at emergency room (ER), placed on 7 days on amoxicillin twice a day, did not clear up infection. Then placed on second course of antibiotic, levofloxacin. The patient had 2 days left and the patient still had an infection. Outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021790421 same reporter/drug/AE with different patient
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear pain, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Ear pain; Sore throat; Deep cough radiating down neck; This is a spontaneous report from a contactable nurse (who is also the patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 05Jan2021 16:00 (Batch/Lot Number: EK9231), as dose 1, single, at age 62 years old, for COVID-19 immunisation, at a hospital. The patient was not pregnant at the time of vaccination. Medical history included Von Willebrand's disease (as reported) from unknow dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines prior to the COVID-19 vaccine. On 25Jan2021, the patient experienced ear pain, sore throat and deep cough radiating down neck. These continued throughout 5 treatments of antibiotics and had not subsided. The events resulted to physician's office visit. The patient underwent COVID-19 nasal swab on an unspecified date with an unknown result. The outcome of the events was not resolved.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of ear pain,sorethroat,cough. The case will be reassessed once new information is available. 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Full blood count, Metabolic function test, Thyroid function test, Tinnitus
Clinical narrative: Hearing loss; Tinnitus/constant ringing in the ears; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via unspecified route of administration in left arm on 03May2021 (lot number: EW0153) at single dose for COVID-19 immunization. The relevant medical history included ongoing high blood pressure (had for 6-7 years), ongoing thyroid problems from 2012, acute asthma from unspecified date, she is overweight from unspecified date. Concomitant medications included unspecified medications. She was on 7-8 different medications. They were maintenance and blood pressure medications. She was on blood pressure medication because she was overweight. She was trying to get off of it. She was not on anything for diabetes or cancer. The patient previously received the first dose of BNT162B2 (Lot Number: ER8732) on 12Apr2021 at the age of 44 years old for Covid-19 immunization and experienced tinnitus. The patient had received both doses of the Pfizer Covid 19 vaccine. She reported after receiving the first dose of the vaccine on 03May2021 (as reported) she had severe tinnitus and hearing loss and constant ring in the. She stated that at first she had a few episodes and didn't know what it was. It got a little better and then she got the second dose and it has gotten worse after that. She thought she was now at a plateau. She clarified that she received the first dose on 12Apr2021. The tinnitus started the next day and had worsened since the second dose. The hearing loss started after the second dose. She received the second dose on 03May2021. The hearing loss started in May2021, a week or two after getting the second dose. She added that she saw her doctor and he mentioned that he saw lots of patients that their blood pressure and hearing were affected. Her doctor didn't know what to do. The doctor was still documenting what his patients were telling him. She saw the doctor on Friday. He did a full blood work panel including a CBC, metabolic panel, thyroid panel. She had a full blood work panel since she had had issues. She wanted to make sure there was nothing in her blood that was alarming other than the hearing loss and tinnitus. They called this morning and said everything was normal and to report it and she could go to a specialist if she wanted to. The patient who had received both doses of the Pfizer BioNTech COVID-19 vaccine and stated that she would like to report an adverse event. She did not have the precise dates of vaccination but mentioned that she received the first dose of the Pfizer BioNTech COVID-19 vaccine on 03May2021 (as reported). She mentioned having developed severe tinnitus, hearing loss and constant ringing in the ears since receiving the Pfizer BioNTech COVID19 vaccine and would like to report it. She did not have a request. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Gait disturbance, Migraine, Nervous system disorder, Platelet count
Clinical narrative: platelet count bottomed out; debilitating migraines; stroke like symptoms; unknown neurological disorder; not be able to walk without falling; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25May2021 13:00 at age of 31-year-old (Lot Number: EW0173) at single dose for COVID-19 immunisation at facility pharmacy or drug store. The patient's medical history was not reported. There was no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. There was no other vaccine within 4 weeks prior to the COVID vaccine. The patient previously took bnt162b2 dose 1 for COVID-19 immunisation. On 30May2021, her platelet count bottomed out, she had debilitating migraines that cause stroke like symptoms, she had an unknown neurological disorder that caused her to not be able to walk without falling, 2 hospital stayed. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was hospitalized for the events from May2021 for 5 days. It was unknown if any treatment was received for the events. The patient underwent lab tests and procedures which included platelet count: reduced, platelet count bottomed out on 30May2021, since the vaccination,  the patient had been tested for COVID-19 via nasal swab in 2021 with unknown result. The outcome of the events was not resolved.; Sender's Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events platelet count decreased, migraine, cerebrovascular accident, nervous system disorder and gait disturbance.  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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, SARS-CoV-2 test
Clinical narrative: platelet count bottomed out; debilitating migraines; stroke like symptoms; unknown neurological disorder; not be able to walk without falling; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25May2021 13:00 at age of 31-year-old (Lot Number: EW0173) at single dose for COVID-19 immunisation at facility pharmacy or drug store. The patient's medical history was not reported. There was no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. There was no other vaccine within 4 weeks prior to the COVID vaccine. The patient previously took bnt162b2 dose 1 for COVID-19 immunisation. On 30May2021, her platelet count bottomed out, she had debilitating migraines that cause stroke like symptoms, she had an unknown neurological disorder that caused her to not be able to walk without falling, 2 hospital stayed. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was hospitalized for the events from May2021 for 5 days. It was unknown if any treatment was received for the events. The patient underwent lab tests and procedures which included platelet count: reduced, platelet count bottomed out on 30May2021, since the vaccination,  the patient had been tested for COVID-19 via nasal swab in 2021 with unknown result. The outcome of the events was not resolved.; Sender's Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events platelet count decreased, migraine, cerebrovascular accident, nervous system disorder and gait disturbance.  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional
Clinical narrative: Shortness of breath was caused by movement; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 30Mar2021 12:00 (at 36-year-old, non-pregnant at the time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication was none. No other vaccine in four weeks. No other medications in two weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 09Mar2021 12:00 (at 36-year-old) as dose 1, single for COVID-19 immunization. The patient experienced shortness of breath on 12Apr2021 22:45. Seriousness criteria was reported as disabling/incapacitating. Clinical details: the patient started having shortness of breath two weeks after the second dose. Initially it was very severe. She spent that week mostly in bed. Shortness of breath was caused by movement. She was still having it. She still cannot do chores. Her doctors were having a hard time figuring out what has happened. Now they wanted her to see a heart specialist. The event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No treatment was received. The outcome of the event was not recovered. No covid prior vaccination. No covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Dizziness, Dyspnoea, Heart rate, Heart rate abnormal
Clinical narrative: heartache jumped even during short walking; significantly elevated resting heart rate of 100bpm and slow walking heart rate of 125bpm and evening parking above 140bpm; shortness of breath; a bit of dizziness; heart rate during light activity feels strained; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 09:00 at age of 56-year-old (Lot Number: EW0153) as dose 2, single for covid-19 immunisation.  The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Pfizer, Lot number EP7534) on 17Mar2021 08:00 PM at age of 56-year-old in Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient had no other medical history. There were no concomitant medications.  It was reported his normal resting heartrate was 65bpm. Within 6 hours of the second injection, he experienced significantly elevated resting heart rate of 100bpm and slow walking heart rate of 125bpm and evening parking above 140bpm just walking to the bathroom. This condition lasted for three days, lessening day to day. However, his resting heart rate remained higher than to the average with periods of rapid and sometimes uneven feeling heartbeat for a couple weeks. He also experienced shortness of breath and a bit of dizziness when his heartache jumped even during short walking. Currently, resting heart rate is back to his normal zone but his heart rate during light activity feels strained, with shortness of breath. The event onset date was 09Apr2021 09:00, no treatment was received, the outcome of the events was recovered with Sequel.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: heartache jumped even during short walking; significantly elevated resting heart rate of 100bpm and slow walking heart rate of 125bpm and evening parking above 140bpm; shortness of breath; a bit of dizziness; heart rate during light activity feels strained; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 09:00 at age of 56-year-old (Lot Number: EW0153) as dose 2, single for covid-19 immunisation.  The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Pfizer, Lot number EP7534) on 17Mar2021 08:00 PM at age of 56-year-old in Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient had no other medical history. There were no concomitant medications.  It was reported his normal resting heartrate was 65bpm. Within 6 hours of the second injection, he experienced significantly elevated resting heart rate of 100bpm and slow walking heart rate of 125bpm and evening parking above 140bpm just walking to the bathroom. This condition lasted for three days, lessening day to day. However, his resting heart rate remained higher than to the average with periods of rapid and sometimes uneven feeling heartbeat for a couple weeks. He also experienced shortness of breath and a bit of dizziness when his heartache jumped even during short walking. Currently, resting heart rate is back to his normal zone but his heart rate during light activity feels strained, with shortness of breath. The event onset date was 09Apr2021 09:00, no treatment was received, the outcome of the events was recovered with Sequel.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Electric shock sensation, Pain in extremity, Paraesthesia
Clinical narrative: He had electrical shocks throughout his body; experience a prickly/tingling feeling in his arms and upper torso/the sensation migrate to his whole upper body where he felt paresthesia; sore arm; his vision was interrupted where he could see grey like on a TV screen when you do not have a channel - grey static - and it kept happening; This is a spontaneous report from a contactable consumer (patient).  A 59-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jun2021 at single dose in left arm for COVID-19 immunisation at the age of 59-year-old. Lot number was EW0191. Medical history and concomitant medications were none. The patient received vaccine dose on 06Jun2021 in the left arm. Later that day he started to experience a prickly/ tingling feeling in his arms and upper torso. It varied in intensity and has continued since receiving the vaccine. Patient received his first shot back on 06Jun2021 and afterward he had the typical sore arm and then it kind of migrated into paresthesia, like a prickly, tingly feeling in his arm. It lasted for a couple of weeks and was varying in intensity. On 24Jun2021, the sensation migrated to his whole upper body where he felt paresthesia in his upper torso. When, it was never a certain movement, but when he moved at all he would receive an electrical shock throughout his whole body in Jun2021. It was not that he was under paralysis, but his vision was interrupted where he could see grey like on a TV screen when you do not have a channel, grey static and it kept happening in Jun2021. The tingling had radiated in his arm throughout his body and he knew it had to do with the shot. This was new, nothing he had experienced before. Vision loss was considered medically significant. He had electrical shocks throughout his body and it would happen several times, dozens of times throughout the day and it happened just say 30 times, then the next day 15 times, then probably 10 times. Now he was just still with paresthesia throughout his upper body and a tingling feeling. The patient was not treated for the events. The outcome of the events was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chromatopsia, Dissociation, Electric shock sensation, Pain in extremity, Paraesthesia
Clinical narrative: He had electrical shocks throughout his body; experience a prickly/tingling feeling in his arms and upper torso/the sensation migrate to his whole upper body where he felt paresthesia; sore arm; his vision was interrupted where he could see grey like on a TV screen when you do not have a channel - grey static - and it kept happening; This is a spontaneous report from a contactable consumer (patient).  A 59-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jun2021 at single dose in left arm for COVID-19 immunisation at the age of 59-year-old. Lot number was EW0191. Medical history and concomitant medications were none. The patient received vaccine dose on 06Jun2021 in the left arm. Later that day he started to experience a prickly/ tingling feeling in his arms and upper torso. It varied in intensity and has continued since receiving the vaccine. Patient received his first shot back on 06Jun2021 and afterward he had the typical sore arm and then it kind of migrated into paresthesia, like a prickly, tingly feeling in his arm. It lasted for a couple of weeks and was varying in intensity. On 24Jun2021, the sensation migrated to his whole upper body where he felt paresthesia in his upper torso. When, it was never a certain movement, but when he moved at all he would receive an electrical shock throughout his whole body in Jun2021. It was not that he was under paralysis, but his vision was interrupted where he could see grey like on a TV screen when you do not have a channel, grey static and it kept happening in Jun2021. The tingling had radiated in his arm throughout his body and he knew it had to do with the shot. This was new, nothing he had experienced before. Vision loss was considered medically significant. He had electrical shocks throughout his body and it would happen several times, dozens of times throughout the day and it happened just say 30 times, then the next day 15 times, then probably 10 times. Now he was just still with paresthesia throughout his upper body and a tingling feeling. The patient was not treated for the events. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Dyspnoea, Eye disorder, Headache
Clinical narrative: Allergic reaction; Experiencing shortness of breath and indicates can barely breathe; Swelling/tightness and mucous in the face and throat.; Swelling/tightness and mucous in the face and throat.; Sore throat; Chest is getting tighter and tighter; Could not keep her eyes open; First dose Thursday shortly after a pain went down the other arm; Burning down her other arm; Headache; Nausea; Whole body aching; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Jun2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported first dose Thursday (22Jun2021) shortly after a pain went down the other arm. Reporter experiencing shortness of breath and indicated she could barely breathe. She reached out to her doctor for prednisone on recommendations of Pharmacist. She asked if she did just kill herself. Health care professional (HCP) declined prednisone and hung up on reporter. Caller (patient) also indicated swelling/tightness and mucous in the face and throat. She described it as a sore throat. She asked if she was going to die. The caller was calling about the Pfizer COVID shot. The caller got the first shot and shortly after she got burning down her other arm and shortness of breath. The caller woke up in the middle of the night with a headache, nausea, her whole body aching, and she could not keep her eyes open. The caller was still having the allergic reaction. The caller's chest was getting tighter and tighter and she could barely breathe. The caller's pharmacist said to get some prednisone but the health center that the caller went to said no and left the caller with nothing. The caller was freaking out and can barely breathe. The caller thought she was going to die. The caller felt like she just killed herself with the shot. She asked if there was any help out there. It was asked if the caller was really going to die. The case was reported as non-serious. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Nausea, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Allergic reaction; Experiencing shortness of breath and indicates can barely breathe; Swelling/tightness and mucous in the face and throat.; Swelling/tightness and mucous in the face and throat.; Sore throat; Chest is getting tighter and tighter; Could not keep her eyes open; First dose Thursday shortly after a pain went down the other arm; Burning down her other arm; Headache; Nausea; Whole body aching; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Jun2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported first dose Thursday (22Jun2021) shortly after a pain went down the other arm. Reporter experiencing shortness of breath and indicated she could barely breathe. She reached out to her doctor for prednisone on recommendations of Pharmacist. She asked if she did just kill herself. Health care professional (HCP) declined prednisone and hung up on reporter. Caller (patient) also indicated swelling/tightness and mucous in the face and throat. She described it as a sore throat. She asked if she was going to die. The caller was calling about the Pfizer COVID shot. The caller got the first shot and shortly after she got burning down her other arm and shortness of breath. The caller woke up in the middle of the night with a headache, nausea, her whole body aching, and she could not keep her eyes open. The caller was still having the allergic reaction. The caller's chest was getting tighter and tighter and she could barely breathe. The caller's pharmacist said to get some prednisone but the health center that the caller went to said no and left the caller with nothing. The caller was freaking out and can barely breathe. The caller thought she was going to die. The caller felt like she just killed herself with the shot. She asked if there was any help out there. It was asked if the caller was really going to die. The case was reported as non-serious. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Throat tightness
Clinical narrative: Allergic reaction; Experiencing shortness of breath and indicates can barely breathe; Swelling/tightness and mucous in the face and throat.; Swelling/tightness and mucous in the face and throat.; Sore throat; Chest is getting tighter and tighter; Could not keep her eyes open; First dose Thursday shortly after a pain went down the other arm; Burning down her other arm; Headache; Nausea; Whole body aching; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Jun2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported first dose Thursday (22Jun2021) shortly after a pain went down the other arm. Reporter experiencing shortness of breath and indicated she could barely breathe. She reached out to her doctor for prednisone on recommendations of Pharmacist. She asked if she did just kill herself. Health care professional (HCP) declined prednisone and hung up on reporter. Caller (patient) also indicated swelling/tightness and mucous in the face and throat. She described it as a sore throat. She asked if she was going to die. The caller was calling about the Pfizer COVID shot. The caller got the first shot and shortly after she got burning down her other arm and shortness of breath. The caller woke up in the middle of the night with a headache, nausea, her whole body aching, and she could not keep her eyes open. The caller was still having the allergic reaction. The caller's chest was getting tighter and tighter and she could barely breathe. The caller's pharmacist said to get some prednisone but the health center that the caller went to said no and left the caller with nothing. The caller was freaking out and can barely breathe. The caller thought she was going to die. The caller felt like she just killed herself with the shot. She asked if there was any help out there. It was asked if the caller was really going to die. The case was reported as non-serious. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Palpitations, SARS-CoV-2 test
Clinical narrative: received his first dose of the series "back around February or end of March/then got COVID19; got COVID19 "without going anywhere; had shortness of breath with palpitations; had shortness of breath with palpitations; This is a spontaneous report from a contactable consumer (Mother). A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date 2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received his first dose of the series "back around February or end of March." The family then got COVID19 "without going anywhere." After having the virus, he had shortness of breath with palpitations before he had the chance to get the 2nd dose of the COVID19 vaccine.Her son got the 2nd dose of the vaccine 22Jun2021 after the pharmacy advised him, he did not need to re start the vaccine series. Since having the 2nd dose, he has had achy arms, palpitations, shortness of breath, and chest heaviness. The patient underwent lab tests and procedures which included COVID-19: positive on an unspecified date. The outcome of events was unknown.  information about lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Thrombosis
Clinical narrative: I can feel a clot in arm making it very painful; My left arm has been in pain; I cannot use my left arm.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 23Apr2021 11:00 (Lot Number: EW0172) as single dose for covid-19 immunisation at 53 years old. The patient medical history was not reported. Concomitant medication(s) included lisinopril (unknown manufacturer, 5 mg) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955) on 27Mar2021 at 10:00 in left arm when 53 years old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced can feel a clot in arm making it very painful (thrombosis) (medically significant), his left arm has been in pain (pain in extremity) (non-serious) and cannot use his left arm (mobility decreased) (non-serious) on 23Apr2021 with outcome of not recovered. The patient reported that his left arm has been in pain since the time of injection and now he can feel a clot in arm making it very painful and he cannot use his left arm. The patient was not treated for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Metamorphopsia, Vision blurred
Clinical narrative: she is losing her vision completely; patient's vision went blurry after the first vaccine/few days later the patient took the second dose of the vaccine and its 3 months and no vision came back; vision became distorted; This is a spontaneous report from a contactable consumer (patient and her husband). A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 23Feb2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose; dose 2 via an unspecified route of administration on 25Mar2021 (Lot Number: ER8727) as single dose, both at the age of 79-years-old for covid-19 immunisation.  The patient medical history was none.  The patient's concomitant medications were none. The patient had both doses of the Pfizer covid vaccine. After the first dose she complained of visual disturbance which affected her sight, she was losing her vision on 27Feb2021 which went away after 1 month. Patient proceeded to take the second dose, and since has had the same visual disturbance from the previous dose, but this time it has not gone away. The patient received the first dose on 23Feb2021 and on 27Feb2021 the patients vision became distorted. Reporter stated she has seen 3 specialists and was now calling to find out if this side effect has been reported. The patient had been seeing an Ophthalmologist. Then about 20Mar2021 or 21Mar2021, the patient was on bromfenac sodium (PROLENSA), which was like an ibuprofen for the eye, her vision came back. A few days later the patient took the second dose of the vaccine and its 3 months and no vision came back. The patients vision has worsened since March. The patients vision went blurry on 27Feb2021 after the first vaccine and now she was losing her vision completely. The reporter wanted to know what he can do to keep the patient from going blind. Outcome of the events was not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Chills, Erythema of eyelid, Pruritus, Rash
Clinical narrative: rashes on his hand; swelling of his eyelid; Itching; redness of his eyelid; "covid toe" blisters; chill; This is a spontaneous report from a Pfizer sponsored program by two contactable consumers (one of them was patient's wife and the other was patient self).   A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration, administered in Arm on 31Mar2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 57-year-old) for COVID-19 immunisation.  The patient medical history was not reported.  Concomitant medications included ibuprofen; acetylsalicylic acid, ascorbic acid (ASPIRIN).  The patient previously received BNT162B2 (at an unknown age) for COVID-19 immunisation as dose 1 and no reaction reported.  The patient did not take any vaccination 4 weeks prior to COVID 19 Vaccine.  Vaccination Facility Type was a set up clinic.  The patient received his second dose of BNT162B2 on 31Mar2021 and had been experiencing AEs. The patient's wife was wondering what they should do about the AEs. The patient had been having rashes on his hand and swelling of his eyelid. The patient has been diagnosed with the "covid toe" blisters on his toe that keep coming back and getting reinfected, and rashes on his hand that keep coming back and redness of his eyelid for which they had used hydrocortisone. Right after his second dose of BNT162B2, he experienced chill, struggled for a day and that the blisters on his foot and rashes on his hands and then his eyelids appeared 3 or 4 days later.  The consumer wanted to know how long will these AEs last.  Treatment included the patient went up to Podiatrist, they had the patient on some antibiotics for some days or so and then he used hydrocortisone for the itching and he had also taken the Benadryl time to time. Anatomical location of administration was in the arm.  Outcome of the events was unknown.  Information on Lot/Batch information has been requested.