chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspepsia, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Dizziness; Increase heart rate immediately following vaccine; Then just fatigue later in day and carried on a few days later; am experiencing increased Short of breath; heartburn; This is a spontaneous report from a contactable nurse. This 38-year-old female nurse (patient) reported for herself that a 38-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 01May2021 12:30 (Batch/Lot Number: EWU171) as single dose for covid-19 immunisation. Medical history included hypertrophic cardiomyopathy. Concomitant medications included metoprolol taken for an unspecified indication, start and stop date were not reported. The patient experienced dizziness, increase heart rate immediately following vaccine. Then just fatigue later in day and carried on a few days later. Patient had hypertrophic cardiomyopathy and am experiencing increased SOB, heartburn and overall extreme fatigue from 01May2021 12:45. Outcome of events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable other hcp. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 11Feb2021 (Lot number was not reported) as 2ND DOSE, SINGLE; dose 1 intramuscular on 21Jan2021 (Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hypothyroidism (hypothyroid). Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient received 2 doses of Pfizer on 21Jan2021 and 11Feb2021 and went on to develop covid on 06Apr2021. Event result patient to doctor or other healthcare professional office/clinic visit. No treatment received. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: positive on 06Apr2021. The outcome of the events was unknown. The patient is not pregnant.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Brain stem haemorrhage, Dizziness, Headache, Tinnitus
Clinical narrative: Headache; Dizzy; had a hemorrhagic stroke in her left pontine/diagnosed with Pontine hemorrhage; white blood cell count was a little elevated; her ear was ringing; This is a spontaneous report from a contactable consumer (patient's husband). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 43 years old on 24Apr2021 14:00 (lot number EW0171) given in her left arm at single dose for COVID-19 immunization. Medical history included slightly elevated blood pressure. Concomitant medication included amlodipine besilate (NORVASC) for slightly elevated blood pressure. Historical Vaccine included first dose of BNT162B2 (lot number ER8734) at the age of 43 years old given in her left arm on 03Apr2021 between 14:00-16:00 for COVID-19 immunization. Caller said his wife was in the hospital right now. He said she got the Pfizer COVID-19 vaccine on 24Apr2021 and then on 06May2021 she had a headache and was dizzy, then was admitted to the hospital and they found out she had a hemorrhagic stroke in her left pontine. Caller said that he was asked to report it due to proximity of this happening to getting the vaccine. Caller said his wife's headache and feeling dizzy started on 06May2021 at 2:30. He said that there was no treatment done for the headache. Patient described the headache she was experiencing feeling like she was a little dizzy, and said her ear was ringing, so he took her to go to bathroom and she said she didn't think she was able to stand anymore. He said he was holding her. He called the ambulance and they took her to the hospital where she was admitted 06May2021. This was within an hour or so, since she went by ambulance. Patient was diagnosed with pontine hemorrhage, which they could not treat, a pontine hemorrhage was not treatable, it had to stop bleeding on its own. He said for treatment they have let her rest, there was no surgical option for it, and no interventions that could be done. Caller said his wife's white blood cell count was a little elevated, but nothing came to his mind right now. The outcome of the events were unknown. Information on Lot/Batch number was available. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: Headache; Dizzy; had a hemorrhagic stroke in her left pontine/diagnosed with Pontine hemorrhage; white blood cell count was a little elevated; her ear was ringing; This is a spontaneous report from a contactable consumer (patient's husband). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 43 years old on 24Apr2021 14:00 (lot number EW0171) given in her left arm at single dose for COVID-19 immunization. Medical history included slightly elevated blood pressure. Concomitant medication included amlodipine besilate (NORVASC) for slightly elevated blood pressure. Historical Vaccine included first dose of BNT162B2 (lot number ER8734) at the age of 43 years old given in her left arm on 03Apr2021 between 14:00-16:00 for COVID-19 immunization. Caller said his wife was in the hospital right now. He said she got the Pfizer COVID-19 vaccine on 24Apr2021 and then on 06May2021 she had a headache and was dizzy, then was admitted to the hospital and they found out she had a hemorrhagic stroke in her left pontine. Caller said that he was asked to report it due to proximity of this happening to getting the vaccine. Caller said his wife's headache and feeling dizzy started on 06May2021 at 2:30. He said that there was no treatment done for the headache. Patient described the headache she was experiencing feeling like she was a little dizzy, and said her ear was ringing, so he took her to go to bathroom and she said she didn't think she was able to stand anymore. He said he was holding her. He called the ambulance and they took her to the hospital where she was admitted 06May2021. This was within an hour or so, since she went by ambulance. Patient was diagnosed with pontine hemorrhage, which they could not treat, a pontine hemorrhage was not treatable, it had to stop bleeding on its own. He said for treatment they have let her rest, there was no surgical option for it, and no interventions that could be done. Caller said his wife's white blood cell count was a little elevated, but nothing came to his mind right now. The outcome of the events were unknown. Information on Lot/Batch number was available. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Headache, Malaise, Pain
Clinical narrative: Arm was swollen and sore; Arm was swollen and sore; Felt under the weather/Did not feel well; Fever; Felt achy; Headache; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Arm Left on 19Apr2021 11:00 (Lot Number: ER8731) as 1st dose, single for covid-19 immunisation. Medical history included Chronic pain, covid-19 from Jan2021, Aneurysm on an artery to her spleen, Multiple back and hip surgeries, 8 Surgeries, Cholesterol, Osteoporosis, Nerve pain, pain, Multiple failed fusions. Concomitant medications included atorvastatin taken for cholesterol; colecalciferol (VITAMIN D) taken for osteoporosis; gabapentin taken for Nerve pain; marijuana taken for pain; calcium. The patient previous received the Trumemba meningococcal vaccine in 2017 for immunization and experienced Seizures; Meningococcal vaccine for immunization and experienced felt under the weather; Pneumococcal vaccine for immunization. She did not feel well after vaccine. She stated her temperature never got above 99 after the first dose. Arm was swollen and sore, felt under the weather, fever, felt achy, headache; they were occurred maybe 20 to 21 hours after vaccine (20Apr2021). Her arm was swollen and sore. She felt under theadds that this was for about 5 days, her temperature was 99 and that was as high as it got. She felt achy and her arm was sore. She had a headache. She added that this went into the second day and she started feeling worse. She had COVID in January, which is probably why she reacted to the first shot. She stated that is what she has heard. She started to feel better until she got the second shot. The causality as yes. She received a chest xray at the end of Feb2021 and she just saw pulmonologist and has to go back for a pulmonary function test. She confirmed this was from before the vaccine and to follow up after she has had Covid. The patient reported the events as serious as medically significant. The outcome of the events was recovering.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events Arm was swollen and sore, Felt under the weather/Did not feel well, Fever, Felt achy and Headache cannot be excluded.  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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm was swollen and sore; Arm was swollen and sore; Felt under the weather/Did not feel well; Fever; Felt achy; Headache; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Arm Left on 19Apr2021 11:00 (Lot Number: ER8731) as 1st dose, single for covid-19 immunisation. Medical history included Chronic pain, covid-19 from Jan2021, Aneurysm on an artery to her spleen, Multiple back and hip surgeries, 8 Surgeries, Cholesterol, Osteoporosis, Nerve pain, pain, Multiple failed fusions. Concomitant medications included atorvastatin taken for cholesterol; colecalciferol (VITAMIN D) taken for osteoporosis; gabapentin taken for Nerve pain; marijuana taken for pain; calcium. The patient previous received the Trumemba meningococcal vaccine in 2017 for immunization and experienced Seizures; Meningococcal vaccine for immunization and experienced felt under the weather; Pneumococcal vaccine for immunization. She did not feel well after vaccine. She stated her temperature never got above 99 after the first dose. Arm was swollen and sore, felt under the weather, fever, felt achy, headache; they were occurred maybe 20 to 21 hours after vaccine (20Apr2021). Her arm was swollen and sore. She felt under theadds that this was for about 5 days, her temperature was 99 and that was as high as it got. She felt achy and her arm was sore. She had a headache. She added that this went into the second day and she started feeling worse. She had COVID in January, which is probably why she reacted to the first shot. She stated that is what she has heard. She started to feel better until she got the second shot. The causality as yes. She received a chest xray at the end of Feb2021 and she just saw pulmonologist and has to go back for a pulmonary function test. She confirmed this was from before the vaccine and to follow up after she has had Covid. The patient reported the events as serious as medically significant. The outcome of the events was recovering.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events Arm was swollen and sore, Felt under the weather/Did not feel well, Fever, Felt achy and Headache cannot be excluded.  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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Oesophageal pain, Paraesthesia
Clinical narrative: Tingling in esophagus and chest.; warm/burning sensation in esophagus; warm/burning sensation in chest.; This is a spontaneous report from a contactable Other Health Professional (patient). This is the 1st of 2 reports for the second dose.  A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in right arm at age of 34-years, on 11May2021 14:00 (Lot Number: EW0173) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included systemic lupus. And the patient diagnosed with COVID-19 prior to vaccination. She had not tested for COVID-19 since the vaccination. The patient was not pregnant. There were concomitant medications but unspecified (the patient received other medications within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical Vaccine included the first dose of BNT162B2 that was administered in right arm at age of 34-years, on 22Apr2021 10:15 (Lot Number: ER8730) for covid-19 immunisation. The patient experienced tingling and warm/burning sensation in esophagus and chest on 11May2021. Treatment received included Benadryl for above events. Events outcome was unknown.  No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the available information the events Paraesthesia, Oesophageal pain and Chest pain are most likely related to an intercurrent or underlying condition which is not related to the subject drug.  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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Lymph node pain, Vaccination site pain
Clinical narrative: Very unusually heavy period; painful lymph nodes in armpit and under arm of right side where shot was administered; painful lymph nodes in armpit and under arm of right side where shot was administered; This is a spontaneous report from a non-contactable other hcp (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Pregnant at the time of vaccination was No. No known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was none. The patient's concomitant medications were not reported. After 1st shot, the patient experienced painful lymph nodes in armpit and under arm of right side where shot was administered. This pain started 5 days post vaccine and lasted 3 weeks! The patient also experienced very unusually heavy period as well. The adverse events resulted Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Advil, counseling. The outcome of events "painful lymph nodes in armpit and under arm of right side where shot was administered" was not recovered, the other event was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: feeling tired/excessively tired; left arm was shaking a lot/left arm was shaky like a heartbeat; knocked her out; sleepy; her left arm was sore/still had some left arm pain; excessive, bad diarrhea; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female consumer patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170) via an unspecified route of administration, in arm left, on 07May2021 15:00 (at the age of 48-year-old) as single dose for COVID-19 immunization. Medical history included ongoing migraine; patient had another allergic reaction but she wasn't sure what it was from. Her forehead got swollen and she had hives all over her body. It wasn't from medication. Her friend had traveled overseas and brought back candy and she ate a piece of the candy. Within 20 minutes of eating the candy her eyes started to get itchy and the hives started. Concomitant medication included migraine medicine when she needed but she did not get a migraine with the Covid 19 vaccines and patient declined to provide the name of the medication. The patient previously had allergy to cefalexin (KEFLEX), she got really bad diarrhea when she took cefalexin (happened about 3 or 4 years ago). The patient previous receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), in arm left, on 16Apr2021 14:00 (at the age of 48-year-old) as single dose for COVID-19 immunization, then it was the next day she noticed, on 17Apr2021, her tiredness and her arm soreness, the arm soreness only lasted about 2 days, and the tiredness only lasted for a day. Patient received her second vaccine on 07May2021. She felt ok the day she got the vaccine but the following day (08May2021), she was sleepy and her left arm was sore and she thought that was normal. Then Saturday night, 08May2021, she got really excessive, bad diarrhea. She thought maybe that's part of the vaccine maybe it wasn't. The diarrhea continued into Sunday morning, 09May2021 and she called the appointment center for her primary care doctor. Her arm was sore, she was still feeling tired and her left arm was shaking a lot. She asked the appointment center to notify her doctor. She was supposed to work Sunday night, 09May2021, and she needed a work note. She had been leaving messages at her doctor's office and no one was returning her calls. She was wanting to know if someone here at Pfizer could help her. She received the second Covid 19 vaccine on 07May2021 and the second Covid-19 vaccine hit her more and knocked her out the following day (08May2021). She was really excessively tired and her left arm was really sore. When she got up she was resting her arm and her left arm was shaky like a heartbeat. She still had some left arm pain but it's improved. Her left arm shaking lasted for about a day and a half. No AE require a visit to emergency room and physician office. No prior vaccinations (within 4 weeks). The outcome of the event "her left arm was sore/still had some left arm pain" was recovering, of other events was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Aggression, Condition aggravated, Coprolalia, Decreased appetite, Dizziness
Clinical narrative: 1-20 minute bouts where tics appear "seizure-like," repetitive; many persistent involuntary tics including coprolalia and violent motor tics; had one minor chronic tic before vaccination/many persistent involuntary tics including coprolalia and violent motor tics/Noticed increase in severity and frequency; many persistent involuntary tics including coprolalia and violent motor tics; Tics often include hitting oneself and banging head against things/violent; significant distress; persistent headache; chronic fatigue/sleepiness; lightheadedness; decrease in appetite; feeling of pressure in certain locations inside the head; intermittent earaches in both ears; persistent feeling of brain being "on fire," and "like a parasite has invaded the brain."; chronic fatigue/sleepiness; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female non-pregnant patient received bnt162b2  (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 26Mar2021 as first single dose and on 16Apr2021 as second single dose (Batch/Lot number was not reported) for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included asthma, allergy to nuts, penicillin and ongoing chronic tic. No other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Concomitant medications included duloxetine; atomoxetine; hydroxyzine; loratadine. The patient previously took amoxicillin and experienced allergies. The patient experienced neurological symptoms included many persistent involuntary tics including coprolalia and violent motor tics. Smaller tics can be suppressed for minimal amounts of time before uncontrolled, violent/loud tics occur in rapid succession. Tics often include hitting oneself and banging head against things. The patient had one minor chronic tic before vaccination. Initial onset occurred nine days after vaccination from 04Apr2021. Noticed increase in severity and frequency approximately nine days after second dose of Pfizer vaccine. Symptoms cause significant distress. Additional symptoms included: persistent headache (from date of first vaccine to present); chronic fatigue/sleepiness; light-headedness; decrease in appetite; feeling of pressure in certain locations inside the head not related to the skull or skin; intermittent earaches in both ears; persistent feeling of brain being "on fire" and "like a parasite had invaded the brain, start date was 26Mar2021; and "1- 20 minute bouts where tics appear "seizure-like," repetitive, violent, and controlling".  The patient underwent lab tests and procedures which included Spit test: negative (other) on 26Mar2021 and Apr2021, Covid test: negative on 26Mar2021 and on Apr2021. The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received; the patient was not recovered.  Information on lot/batch number has been request.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Emotional distress, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: 1-20 minute bouts where tics appear "seizure-like," repetitive; many persistent involuntary tics including coprolalia and violent motor tics; had one minor chronic tic before vaccination/many persistent involuntary tics including coprolalia and violent motor tics/Noticed increase in severity and frequency; many persistent involuntary tics including coprolalia and violent motor tics; Tics often include hitting oneself and banging head against things/violent; significant distress; persistent headache; chronic fatigue/sleepiness; lightheadedness; decrease in appetite; feeling of pressure in certain locations inside the head; intermittent earaches in both ears; persistent feeling of brain being "on fire," and "like a parasite has invaded the brain."; chronic fatigue/sleepiness; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female non-pregnant patient received bnt162b2  (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 26Mar2021 as first single dose and on 16Apr2021 as second single dose (Batch/Lot number was not reported) for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included asthma, allergy to nuts, penicillin and ongoing chronic tic. No other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Concomitant medications included duloxetine; atomoxetine; hydroxyzine; loratadine. The patient previously took amoxicillin and experienced allergies. The patient experienced neurological symptoms included many persistent involuntary tics including coprolalia and violent motor tics. Smaller tics can be suppressed for minimal amounts of time before uncontrolled, violent/loud tics occur in rapid succession. Tics often include hitting oneself and banging head against things. The patient had one minor chronic tic before vaccination. Initial onset occurred nine days after vaccination from 04Apr2021. Noticed increase in severity and frequency approximately nine days after second dose of Pfizer vaccine. Symptoms cause significant distress. Additional symptoms included: persistent headache (from date of first vaccine to present); chronic fatigue/sleepiness; light-headedness; decrease in appetite; feeling of pressure in certain locations inside the head not related to the skull or skin; intermittent earaches in both ears; persistent feeling of brain being "on fire" and "like a parasite had invaded the brain, start date was 26Mar2021; and "1- 20 minute bouts where tics appear "seizure-like," repetitive, violent, and controlling".  The patient underwent lab tests and procedures which included Spit test: negative (other) on 26Mar2021 and Apr2021, Covid test: negative on 26Mar2021 and on Apr2021. The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received; the patient was not recovered.  Information on lot/batch number has been request.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test negative, Saliva analysis, Seizure like phenomena, Somnolence
Clinical narrative: 1-20 minute bouts where tics appear "seizure-like," repetitive; many persistent involuntary tics including coprolalia and violent motor tics; had one minor chronic tic before vaccination/many persistent involuntary tics including coprolalia and violent motor tics/Noticed increase in severity and frequency; many persistent involuntary tics including coprolalia and violent motor tics; Tics often include hitting oneself and banging head against things/violent; significant distress; persistent headache; chronic fatigue/sleepiness; lightheadedness; decrease in appetite; feeling of pressure in certain locations inside the head; intermittent earaches in both ears; persistent feeling of brain being "on fire," and "like a parasite has invaded the brain."; chronic fatigue/sleepiness; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female non-pregnant patient received bnt162b2  (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 26Mar2021 as first single dose and on 16Apr2021 as second single dose (Batch/Lot number was not reported) for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included asthma, allergy to nuts, penicillin and ongoing chronic tic. No other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Concomitant medications included duloxetine; atomoxetine; hydroxyzine; loratadine. The patient previously took amoxicillin and experienced allergies. The patient experienced neurological symptoms included many persistent involuntary tics including coprolalia and violent motor tics. Smaller tics can be suppressed for minimal amounts of time before uncontrolled, violent/loud tics occur in rapid succession. Tics often include hitting oneself and banging head against things. The patient had one minor chronic tic before vaccination. Initial onset occurred nine days after vaccination from 04Apr2021. Noticed increase in severity and frequency approximately nine days after second dose of Pfizer vaccine. Symptoms cause significant distress. Additional symptoms included: persistent headache (from date of first vaccine to present); chronic fatigue/sleepiness; light-headedness; decrease in appetite; feeling of pressure in certain locations inside the head not related to the skull or skin; intermittent earaches in both ears; persistent feeling of brain being "on fire" and "like a parasite had invaded the brain, start date was 26Mar2021; and "1- 20 minute bouts where tics appear "seizure-like," repetitive, violent, and controlling".  The patient underwent lab tests and procedures which included Spit test: negative (other) on 26Mar2021 and Apr2021, Covid test: negative on 26Mar2021 and on Apr2021. The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received; the patient was not recovered.  Information on lot/batch number has been request.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Tic
Clinical narrative: 1-20 minute bouts where tics appear "seizure-like," repetitive; many persistent involuntary tics including coprolalia and violent motor tics; had one minor chronic tic before vaccination/many persistent involuntary tics including coprolalia and violent motor tics/Noticed increase in severity and frequency; many persistent involuntary tics including coprolalia and violent motor tics; Tics often include hitting oneself and banging head against things/violent; significant distress; persistent headache; chronic fatigue/sleepiness; lightheadedness; decrease in appetite; feeling of pressure in certain locations inside the head; intermittent earaches in both ears; persistent feeling of brain being "on fire," and "like a parasite has invaded the brain."; chronic fatigue/sleepiness; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female non-pregnant patient received bnt162b2  (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 26Mar2021 as first single dose and on 16Apr2021 as second single dose (Batch/Lot number was not reported) for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included asthma, allergy to nuts, penicillin and ongoing chronic tic. No other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Concomitant medications included duloxetine; atomoxetine; hydroxyzine; loratadine. The patient previously took amoxicillin and experienced allergies. The patient experienced neurological symptoms included many persistent involuntary tics including coprolalia and violent motor tics. Smaller tics can be suppressed for minimal amounts of time before uncontrolled, violent/loud tics occur in rapid succession. Tics often include hitting oneself and banging head against things. The patient had one minor chronic tic before vaccination. Initial onset occurred nine days after vaccination from 04Apr2021. Noticed increase in severity and frequency approximately nine days after second dose of Pfizer vaccine. Symptoms cause significant distress. Additional symptoms included: persistent headache (from date of first vaccine to present); chronic fatigue/sleepiness; light-headedness; decrease in appetite; feeling of pressure in certain locations inside the head not related to the skull or skin; intermittent earaches in both ears; persistent feeling of brain being "on fire" and "like a parasite had invaded the brain, start date was 26Mar2021; and "1- 20 minute bouts where tics appear "seizure-like," repetitive, violent, and controlling".  The patient underwent lab tests and procedures which included Spit test: negative (other) on 26Mar2021 and Apr2021, Covid test: negative on 26Mar2021 and on Apr2021. The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received; the patient was not recovered.  Information on lot/batch number has been request.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Headache, Hypersomnia, Nausea, Thrombosis
Clinical narrative: Vaginal bleeding in a menopausal woman with blood clots.; Vaginal bleeding in a menopausal woman with blood clots.; Also slept for 13 hours the day following the shot and had a continual headache with nausea; Also slept for 13 hours the day following the shot and had a continual headache with nausea; Also slept for 13 hours the day following the shot and had a continual headache with nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06May2021 at 09:45 at single dose in left arm for COVID-19 immunisation at the age of 56-year-old. Lot number EW0183. Medical history included menopausal woman. Concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 at 10:30, Lot number EW0164, dose number: 1, in left arm. On 06May2021, the patient also slept for 13 hours the day following the shot and had a continual headache with nausea. On 10May2021, the patient experienced vaginal bleeding in a menopausal woman with blood clots. It was very concerning; the patient was going to Ob/Gyn soon. The patient underwent ultrasound and biopsy. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Follow up needed, further information has been requested
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vaginal haemorrhage
Clinical narrative: Vaginal bleeding in a menopausal woman with blood clots.; Vaginal bleeding in a menopausal woman with blood clots.; Also slept for 13 hours the day following the shot and had a continual headache with nausea; Also slept for 13 hours the day following the shot and had a continual headache with nausea; Also slept for 13 hours the day following the shot and had a continual headache with nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06May2021 at 09:45 at single dose in left arm for COVID-19 immunisation at the age of 56-year-old. Lot number EW0183. Medical history included menopausal woman. Concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 at 10:30, Lot number EW0164, dose number: 1, in left arm. On 06May2021, the patient also slept for 13 hours the day following the shot and had a continual headache with nausea. On 10May2021, the patient experienced vaginal bleeding in a menopausal woman with blood clots. It was very concerning; the patient was going to Ob/Gyn soon. The patient underwent ultrasound and biopsy. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Follow up needed, further information has been requested
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Rash pruritic, Urticaria
Clinical narrative: 90% of his body has a rash on it; breaking out in rash; it's over like 45% of his body, his toes and his legs; that's very itchy; rash all over his body; Hives covering over 50% of my body that randomly come and go; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (mother) and a contactable consumer (patient) reported that a 37-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 07May2021 (Batch/Lot Number: EW0168) as single dose for covid-19 immunization. Medical history included adult-onset diabetes developed just a few years ago that was controlled with a pill. He was not a insulin diabetic patient and unknown renal disorder Concomitant medication included metformin taken for diabetes; lisinopril taken for diabetes as to protect kidneys. He had his first vaccine on Friday evening of this last week and by Monday he was in the ER, 90% of his body has a rash on it, and it looked out as he poured some hot water on him, it's over like 45% of his body, his toes and his legs. He went to an urgent care, walk-in and that's very itchy and so they sent him over to look in hospital and they put him on steroids and Benadryl and anti-itchy cream (Treatment), he was missing work because he had got this rash all over his body. The event was also reported as hives covering over 50% of body that randomly come and go. Events were started from May2021. The patient underwent lab tests and procedures which included blood sugar monitor continuously which was tested on machine. The outcome of the events was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: First dose: just some pain; First dose: fatigue; This is a spontaneous report from a contactable nurse (the patient herself). A 39-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6199, Exp 30Jun2021) intramuscular in left arm on 04Mar2021 12:50 (at the age of 39-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes flu shot in Feb2021 (exact date unspecified). Other relevant medical history was not reported. Concomitant medications included vitamins (unspecified) taken for years. The patient experienced some fatigue from 04Mar2021 and just some pain on an unspecified date. It was further specified that she experienced fatigue the same day/night she got the first vaccine. She was just really, really exhausted and mentioned she just had some pain. She confirmed she recovered completely from the fatigue and pain. No seriousness was reported for the events. The events resolved on an unspecified date and both were considered related to the vaccine.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Swelling face
Clinical narrative: felt like Bell's palsy like a paralysis in my face; Swelling in face; This is a spontaneous report from a contactable consumer (the patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0168) via an unspecified route of administration, administered in Arm Right on 11May2021 10:00 at age of 63-year-old at single dose for COVID-19 immunisation. Medical history included Bell's palsy (reported as "I had in my life I had Bell's palsy"). No other medical history. There were no concomitant medications. On 11May2021, the patient had like some swelling in her face and she was still having it. She had in her life she had Bell's palsy and that was what it felt like, it felt like paralysis in her face (also reported as "felt like bell's palsy like a paralysis in my face") and she wondered if she had to go to the emergency room. No treatment received for the events. No investigation assessment. The outcome of event "swelling in face" was not recovered, the outcome of event "felt like bell's palsy like a paralysis in my face" was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Pain in extremity
Clinical narrative: lot of pain in the vaccinated arm/ 2 of her fingers feel pain; 2 of her fingers feel pain, and numb; pain is all the way in the back and it's getting worse; This is a spontaneous report from a contactable consumer reporting for her wife.    A 50-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported.     The patient received the first dose of BNT162B2 on an unknown date. The patient's concomitant medications were not reported.  The patient experienced lot of pain in the vaccinated arm/ 2 of her fingers feel pain, 2 of her fingers feel numb,  pain is all the way in the back and it's getting worse  all on an unspecified date with outcome of unknown.   She has been taking some medication ibuprofen 800mg 3 times a day but that's not helping The reporter is wondering  if the patient should be  taken  to the ER or wait 3 days to see the doctor This has been going on for 2 weeks already. The reporter doesn't know if this is  the side effect from the vaccine. If they put it in the wrong position or in the nerve. She's not getting better and she's getting worse and it's past 7 days.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Pain; Headache; Severe Myalgia to legs nest day after 2nd dose then to shoulders, arms; This is a spontaneous report from a contactable physician. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205) via intramuscular on 27Feb2021 (at the age of 37-year-old) as single dose for COVID-19 immunisation. Medical history included right blepharospasm, history of angioedema, vulvodynia, and endometriosis. Concomitant medication was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EM9810) intramuscularly on 06Feb2021 (at the age of 37-year-old) as single dose for COVID-19 immunisation. The patient experienced pain and headache on an unspecified date, experienced severe myalgia to legs nest day after 2nd dose then to shoulders, arms on 28Feb2021. None prior vaccinations within 4 weeks. Seriousness criteria for event pain was reported as disability. The outcome of the events was unknown. Reporter considered the suspect product had a causal effect to the adverse event.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205) to reported events is possible based on temporal association and known profile of the product.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm only; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received bnt162b2 (BNT162B2), first dose via an unspecified route of administration on 26Feb2021 at age of 68-year-old (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included the patient had Bell's Palsy about 10 years ago. The patient's concomitant medications were not reported.  The patient experienced sore arm only on 26Feb2021 with outcome of unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: experienced small amount of pain at the injection site of left shoulder/his coworker experienced similar side effects with the Pfizer Covid-19 Vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history was and concomitant medications were not reported. On an unspecified date, the patient experienced small amount of pain at the injection site of left shoulder/his coworker experienced similar side effects with the Pfizer COVID-19 vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test
Clinical narrative: feeling kind of sick on it two days later on Saturday on 17Apr2021/I have got the COVID/he had left was like a little pneumonia; This is a spontaneous report from a contactable consumer (patient). A 43 years old male patient received  Covid-19 Vaccine (unspecified trade name) dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: GD7533) as single dose for covid-19 immunization. Medical history included blood testosterone low. Concomitant medication included testosterone cipionate taken for testosterone low regularly for a year 500 ml a week. The patient didn't have any adverse effect or anything like but he can add a peculiar situation where he got first vaccination and then after he didn't know when he actually got COVID. The patient got first vaccine on Thursday and started feeling kind of sick on it two days later on Saturday on 17Apr2021 and then the patient got tested on Sunday on 18Apr2021 and it actually turned out that the patient had got the COVID. The pharmacist said well don't get second one if still have symptoms. The patient had not got the second vaccination. The second shot was scheduled for last week on 06May2021 when the patient cancelled it and he still had symptoms. He felt pretty fine, he thought all he had left was like a little pneumonia. He took for pneumonia antibiotic Benzonatate 100 mg. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Peripheral swelling
Clinical narrative: had swelling off and on in different limbs but not in this arm; after he had the Pfizer Covid vaccine, left arm had gotten bigger/arm that he got it in was swollen, almost the entire arm; had swelling off and on in different limbs but not in this arm; after he had the Pfizer Covid vaccine, left arm had gotten bigger/arm that he got it in was swollen, almost the entire arm; This is a spontaneous report from a contactable physician (patient himself). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on an unspecified date (Batch/Lot number and Expiration date were not reported) as the 1st dose, single for COVID-19 immunization. Relevant medical history included an accident a year prior reporting in 2020 and had swelling off and on in different limbs, but not in this arm from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient stated that he received two doses of the Pfizer vaccine, the last one was one week prior reporting. He stated that the arm that he got it in was swollen, almost the entire arm and wanted to know if he needed to get it checked out. The patient further stated that he had an accident a year prior reporting and had swelling off and on in different limbs, but not in this arm; he stated that after he had the Pfizer Covid vaccine, the left arm had gotten bigger on an unspecified date. The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on an unspecified date (Batch/Lot number and Expiration date were not reported) to reported events is possible based on temporal association and known profile of the product.