chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Joint swelling, Ligament pain, Ligamentitis
Clinical narrative: All joints are inflamed, swollen and extremely painful.; All joints are inflamed, swollen and extremely painful.; All joints are inflamed, swollen and extremely painful.; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; This is a spontaneous report from contactable consumer (patient). A non-pregnant 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 26Feb2021 at 18:30 (at the age of 73 years old) (Lot Number: EN6202, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included lupus and known allergies to penicillin and cephalosphorins. Concomitant medications included prednisone; and boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN). The patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, unknown expiration) on 03Feb2021 at 20:30 in right arm for COVID-19 immunisation at the age of 73 years old. The patient experienced all joints are inflamed, swollen and extremely painful; and muscles, ligaments, tendons etc are also inflamed and painful on 27Feb2021 at 05:00. The patient not been able to exit her house. The events resulted in physician office visit. The patient received treatment for the events. The patient did not receive other vaccines in four weeks. The patient had not yet recovered from the events. The events were assessed as serious (disability).   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Myositis, Tendon pain, Tendonitis
Clinical narrative: All joints are inflamed, swollen and extremely painful.; All joints are inflamed, swollen and extremely painful.; All joints are inflamed, swollen and extremely painful.; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; This is a spontaneous report from contactable consumer (patient). A non-pregnant 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 26Feb2021 at 18:30 (at the age of 73 years old) (Lot Number: EN6202, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included lupus and known allergies to penicillin and cephalosphorins. Concomitant medications included prednisone; and boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN). The patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, unknown expiration) on 03Feb2021 at 20:30 in right arm for COVID-19 immunisation at the age of 73 years old. The patient experienced all joints are inflamed, swollen and extremely painful; and muscles, ligaments, tendons etc are also inflamed and painful on 27Feb2021 at 05:00. The patient not been able to exit her house. The events resulted in physician office visit. The patient received treatment for the events. The patient did not receive other vaccines in four weeks. The patient had not yet recovered from the events. The events were assessed as serious (disability).   No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Poor quality product administered, Product temperature excursion issue
Clinical narrative: she received the first dose of the Pfizer covid 19 vaccine on 07Apr2021 and was told it was ineffective because of the way it was stored.; she received the first dose of the Pfizer covid 19 vaccine on 07Apr2021 and was told it was ineffective because of the way it was stored.; she received the first dose of the Pfizer covid 19 vaccine on 07Apr2021 and was told it was ineffective because of the way it was stored.; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 14:00 (Lot number: UNKNOWN) at the age of 18 years, as a single dose for COVID-19 immunization.  Medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient reported that she received the first dose of the Pfizer COVID-19 vaccine on 07Apr2021 and was told it was ineffective because of the way it was stored. She received notification that Covid-19 vaccine was stored incorrectly and that the vaccine was ineffective. The patient stated they informed her she needed to be revaccinated but did not tell her when. The patient wanted to know what Pfizer says about that. She wanted to see if Pfizer would recommended that she restart the Covid-19 vaccine series and get both doses of the Covid-19 vaccine.  The patient reported that she was not getting much help on what she should do next. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: getting infected with covid after the 1st dose; getting infected with covid after the 1st dose.; This is a spontaneous report from a contactable Pharmacist. A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 30Jan2021 (Lot number: UNKNOWN) as a single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The pharmacist inquired  that since it has been more than 6 weeks, whether the patient needs to restart the covid vaccine series after getting infected with covid after the 1st dose. The pharmacist would like to know whether the patient should get the 2nd dose of the covid vaccine or if his history of covid infection is considered the 2nd dose. The 1st dose was  received on 30Jan2021 and he contracted covid between both doses so 2nd dose was postponed. The patient had lab tests which included sars-cov-2 test: infected on unspecified date. He has had several negatives since then.  The clinical outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Magnetic resonance imaging, Tinnitus
Clinical narrative: hearing loss; bad tinnitus in his left ear; This is a spontaneous report from a contactable consumer.   A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on 14Feb2021 11:30 (Batch/Lot Number: EL9266; Expiration Date: 31May2021) as SINGLE DOSE (at the age of 39-year-old years) for covid-19 immunisation.  The Patient received second dose in left arm on 07Mar2021 11:45 lot number: EN6201, expiration date: Jun2021.  Medical history included ongoing asthma which was diagnosed when he was 9 years old. He states the he is also susceptible to chest infections.  There were no concomitant medications.  The patient experienced hearing loss (medically significant) on Feb2021 with outcome of not recovered and bad tinnitus in his left ear on Feb2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included acoustic stimulation tests: this morning it's in his right ear on 21Apr2021 and  acoustic stimulation tests: hearing loss on 2021 the hearing loss was initially only in his left ear; magnetic resonance imaging: negative on unspecified date.  He is an audio engineer and sound editor and that is how he makes his money. He states that today (21Apr2021) will make the 5th hearing test in total and his hearing hasn't gotten any better.  Three weeks ago it was only the left ear and as of today the right (21Apr2021) ear is also being affected.  Symptoms started in Left ear and are now in the right ear as well. An MRI was done and that was negative. He thinks it is related to the vaccine. The patient went to the physician office for treatment.  The patient did not have additional vaccines administered on same date of the Pfizer Suspect.  The patient had no prior vaccination within 4 weeks.    Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pneumonia, Pruritus, SARS-CoV-2 test
Clinical narrative: Pneumonia; Itchy, dry, non-productive cough; Itchy, dry, non-productive cough; Itchy, dry, non-productive cough; This is a spontaneous report from a contactable consumer (reporting for self). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),dose 1 via an unspecified route of administration, administered in Left Arm on 03Apr2021 (Batch/Lot Number: ER8732) as SINGLE DOSE (at the age of 63 years) for covid-19 immunisation.  Medical history included ongoing chronic obstructive pulmonary disease (diagnosed for a decade), ongoing hypertension (diagnosed for a decade), ongoing type 2 diabetes mellitus (5-6 years ago diagnosed, very well maintained type 2 diabetes), ongoing pneumonia (He has been hospitalized 4 different times for pneumonia. In Dec2020 when he had pneumonia, they did not hospitalize him. He has had pneumonia 5 time since 1982. Concomitant medication included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. "He gets the flu shot every, and he has had the shingles shot. He also gets the pneumonia vaccine every 2 years." The patient experienced pneumonia (hospitalization) on an unspecified date with outcome of not recovered, itchy, on 08Apr2021 with outcome of unknown, dry cough on 08Apr2021 with outcome of not recovered and non-productive cough on 08Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on Oct2020.  On 13Apr2021 He reported it to the doctor and he told the patient to skip a dose of Lisinopril that sometimes it can have those symptoms of a deep nonproductive cough. He skipped the medication, and it hasn't gotten better. He thinks it is from the COVID vaccine.  At the peak of his cough, he probably had 6 days where he coughed uncontrollably for 24 hours in a day.  He still has a cough.  Therapeutic measures were taken as a result of pneumonia. The doctor didn't do a chest X-ray or COVID test.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate, Heart rate abnormal, Pain in extremity
Clinical narrative: Most arrhythmias and heart beat subsided; Most arrhythmias and heart beat subsided; Pain in arm kept her awake that night; This is a spontaneous report from a non-contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced arrhythmia, heart rate abnormal and pain in arm. The events were described as "some side effects she had the first 5 minutes after the injection most arrhythmias and heart beat subsided within first 5 minutes of having the shot, they asked me to wait 15 minutes. The pain in arm kept her awake that night". The patient recovered from arrhythmia and heart rate abnormal on an unspecified date, while clinical outcome of pain in arm was unknown at time of this report.  No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear discomfort, Ear pain, Hypoaesthesia
Clinical narrative: ear is still blocked; ear aches; ear aches and is numb; no hearing in my left ear; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown), via an unspecified route of administration in the left arm on 25Feb2021 at 17:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history was none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 27Feb2021 at 07:00, the patient woke up with no hearing in the left ear. Some hearing had come back but the ear was still blocked as of an unspecified date. The ear ached and was numb as of an unspecified date. The patient visited the ear nose and throat (ENT) doctor and was treated with steroids, twice, for the events. The patient was scheduled for an MRI. The patient reported that she was perfectly fine with no problems prior to the vaccine. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of "no hearing in my left ear", "ear is still blocked", "ear aches and is numb" was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Hypersensitivity
Clinical narrative: shortness of breath; My heart rate was up; Feels like I'm having an allergic reaction; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history included she had severe allergies. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunization and didn't have anything. Patient stated she took her 2nd dose last Friday (16Apr2021) and 2 hours after her heart rate was up and had shortness of breath. It was not consistent it went away and came back. It started with her heart rate going up then the shortness of breath, then she had to do breathing exercise to calm down and it went away. She didn't have anything after the 1st dose. Patient added she had severe allergies, she carried an EpiPen, this felt like she was having an allergic reaction. She wished she never took this vaccine. Patient said she would be seeing her doctor today. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Pruritus, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: typical reported symptoms that mimic COVID; I went into a-fib; itchy inner arm; This is a spontaneous report from a contactable other HCP (healthcare professional/patient). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. It was reported that the patient had no known diseases or conditions. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications ("other medications in two weeks") were reported as no. It was reported that the patient was not on any medications prior to the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EL9266) via an unspecified route of administration in the right arm on 03Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation and experienced sore arm. On 25Mar2021 at 08:45 the patient experienced I went into a-fib and itchy inner arm and on an unspecified date the patient experienced typical reported symptoms that mimic COVID. The clinical course was reported as follows "I had just sore arm after shot 1, but after shot 2 I went into a-fib. I also had the typical reported symptoms that mimic COVID and itchy inner arm." The adverse events I went into a-fib and itchy inner arm resulted in a physician office visit and the event I went into a-fib required treatment with blood thinner and calcium blocker. The patient was tested for COVID-19 post vaccination on 07Apr2021 with a nasal swab which was negative. The clinical outcomes of the events I went into a-fib and itchy inner arm were not recovered/not resolved and the clinical outcome of typical reported symptoms that mimic COVID were unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Atrial fibrillation cannot be excluded.  The case will be reassessed if additional information becomes 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: I had DVTs in my right calf that landed me in the ER a week after my first shot.; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 at 10:45 AM (Lot number: UNKNONW), at the age of 33 years, as a single dose for COVID-19 immunization.  Medical history included protein C deficiency, drug hypersensitivity to Sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no concomitant medications. The patient reported "I had DVT's in my right calf that landed me in the emergency room (ER) a week after my first shot on 08Mar2021. Therapeutic measures were taken as a result of "I had DVTs in my right calf that landed me in the emergency room (ER) and included blood thinning medication. The clinical outcome of DVT was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Muscle spasms, Nausea, Pyrexia
Clinical narrative: vomiting; a severe migraine headache for 5-7 days; chills; fever; vertigo; slept all day long; she also had a full leg charlie horse; Nausea; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The next day on 07Apr2021, the patient vomited at least 30 times, had a severe migraine headache for 5-7 days as well as chills, fever, vertigo and slept all day long. She also had a full leg charlie horse. When she spoke to her HCP about the vaccine, they suggested getting the second dose and enduring the side effects is better than dying of covid and wrote prescriptions for migraines and nausea. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vertigo, Vomiting
Clinical narrative: vomiting; a severe migraine headache for 5-7 days; chills; fever; vertigo; slept all day long; she also had a full leg charlie horse; Nausea; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The next day on 07Apr2021, the patient vomited at least 30 times, had a severe migraine headache for 5-7 days as well as chills, fever, vertigo and slept all day long. She also had a full leg charlie horse. When she spoke to her HCP about the vaccine, they suggested getting the second dose and enduring the side effects is better than dying of covid and wrote prescriptions for migraines and nausea. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable Other healthcare professional (HCP). A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 03Apr2021 (Lot number was not reported) as SINGLE DOSE (at age of 57 years old) for covid-19 immunisation.  Medical history included diabetes from an unknown date and unknown if ongoing , covid from an unknown date and unknown if ongoing.  Patient did no have any known allergies. Concomitant medication(s) included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; glipizide taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported.   The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The vaccination was given in a hospital. The patient experienced bell's palsy on 11Apr2021. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of bell's palsy which included Prednisone, Valacyclovir. Outcome of the event was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information about lot/batch number has been requested.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between event Bell's Palsy and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) 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: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Aphthous ulcer, Drug interaction, Platelet count increased, Tongue discolouration, Tongue ulceration
Clinical narrative: chancre like sore on his tongue; chancre like sore on his tongue; welts on his tongue; some white circular canker type sores came on my tongue around the tip area; Vaccine and hydroxyurea might be working against each other; This is a spontaneous report from a contactable consumer. A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 70 years old) for covid-19 immunisation;  hydroxyurea (HYDROXYUREA), route of administration, start and stop date, batch/lot number and dose were not reported for Platelet count high.  The patient had been taking hydroxyurea for 24 years now. The patient medical history was not reported.  The patient's concomitant medications were not reported.  After the first dose, in 2021, the patient experienced chancre like sore on his tongue and some white circular canker type sores came on my tongue around the tip area. After the first one, there was some welts that came up on my tongue in 2021. So from 19Feb2021 until a couple days ago he has not been able to see the doctor who prescribed the hydroxyurea to him and when he met with him he was saying that the vaccine and hydroxyurea might be working against each other. So, today he has not taken any hydroxyurea. He has not done anything to the welts, they look almost like canker sores but they are clearing up on their own right now. He has not taken it from yesterday morning and the welts seem to be clearing up now since he did not take it but he doesn't know for how long he can not take the hydroxyurea. He received the second shot on 15Mar2021. The action taken in response to the event for hydroxyurea was temporarily withdrawn on an unspecified date. Outcome of the events chancre like sore on his tongue, welts on his tongue, some white circular canker type sores came on my tongue around the tip area was recovering. Outcome of the event Vaccine and hydroxyurea might be working against each other was unknown.  Information about the Lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Urticaria
Clinical narrative: chancre like sore on his tongue; chancre like sore on his tongue; welts on his tongue; some white circular canker type sores came on my tongue around the tip area; Vaccine and hydroxyurea might be working against each other; This is a spontaneous report from a contactable consumer. A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 70 years old) for covid-19 immunisation;  hydroxyurea (HYDROXYUREA), route of administration, start and stop date, batch/lot number and dose were not reported for Platelet count high.  The patient had been taking hydroxyurea for 24 years now. The patient medical history was not reported.  The patient's concomitant medications were not reported.  After the first dose, in 2021, the patient experienced chancre like sore on his tongue and some white circular canker type sores came on my tongue around the tip area. After the first one, there was some welts that came up on my tongue in 2021. So from 19Feb2021 until a couple days ago he has not been able to see the doctor who prescribed the hydroxyurea to him and when he met with him he was saying that the vaccine and hydroxyurea might be working against each other. So, today he has not taken any hydroxyurea. He has not done anything to the welts, they look almost like canker sores but they are clearing up on their own right now. He has not taken it from yesterday morning and the welts seem to be clearing up now since he did not take it but he doesn't know for how long he can not take the hydroxyurea. He received the second shot on 15Mar2021. The action taken in response to the event for hydroxyurea was temporarily withdrawn on an unspecified date. Outcome of the events chancre like sore on his tongue, welts on his tongue, some white circular canker type sores came on my tongue around the tip area was recovering. Outcome of the event Vaccine and hydroxyurea might be working against each other was unknown.  Information about the Lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Chest X-ray normal, Electrocardiogram normal, Glossodynia, Heart rate increased
Clinical narrative: chancre like sore on his tongue; chancre like sore on his tongue; welts on his tongue; some white circular canker type sores came on my tongue around the tip area; Vaccine and hydroxyurea might be working against each other; This is a spontaneous report from a contactable consumer. A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 70 years old) for covid-19 immunisation;  hydroxyurea (HYDROXYUREA), route of administration, start and stop date, batch/lot number and dose were not reported for Platelet count high.  The patient had been taking hydroxyurea for 24 years now. The patient medical history was not reported.  The patient's concomitant medications were not reported.  After the first dose, in 2021, the patient experienced chancre like sore on his tongue and some white circular canker type sores came on my tongue around the tip area. After the first one, there was some welts that came up on my tongue in 2021. So from 19Feb2021 until a couple days ago he has not been able to see the doctor who prescribed the hydroxyurea to him and when he met with him he was saying that the vaccine and hydroxyurea might be working against each other. So, today he has not taken any hydroxyurea. He has not done anything to the welts, they look almost like canker sores but they are clearing up on their own right now. He has not taken it from yesterday morning and the welts seem to be clearing up now since he did not take it but he doesn't know for how long he can not take the hydroxyurea. He received the second shot on 15Mar2021. The action taken in response to the event for hydroxyurea was temporarily withdrawn on an unspecified date. Outcome of the events chancre like sore on his tongue, welts on his tongue, some white circular canker type sores came on my tongue around the tip area was recovering. Outcome of the event Vaccine and hydroxyurea might be working against each other was unknown.  Information about the Lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Laboratory test abnormal, Urticaria
Clinical narrative: chancre like sore on his tongue; chancre like sore on his tongue; welts on his tongue; some white circular canker type sores came on my tongue around the tip area; Vaccine and hydroxyurea might be working against each other; This is a spontaneous report from a contactable consumer. A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 70 years old) for covid-19 immunisation;  hydroxyurea (HYDROXYUREA), route of administration, start and stop date, batch/lot number and dose were not reported for Platelet count high.  The patient had been taking hydroxyurea for 24 years now. The patient medical history was not reported.  The patient's concomitant medications were not reported.  After the first dose, in 2021, the patient experienced chancre like sore on his tongue and some white circular canker type sores came on my tongue around the tip area. After the first one, there was some welts that came up on my tongue in 2021. So from 19Feb2021 until a couple days ago he has not been able to see the doctor who prescribed the hydroxyurea to him and when he met with him he was saying that the vaccine and hydroxyurea might be working against each other. So, today he has not taken any hydroxyurea. He has not done anything to the welts, they look almost like canker sores but they are clearing up on their own right now. He has not taken it from yesterday morning and the welts seem to be clearing up now since he did not take it but he doesn't know for how long he can not take the hydroxyurea. He received the second shot on 15Mar2021. The action taken in response to the event for hydroxyurea was temporarily withdrawn on an unspecified date. Outcome of the events chancre like sore on his tongue, welts on his tongue, some white circular canker type sores came on my tongue around the tip area was recovering. Outcome of the event Vaccine and hydroxyurea might be working against each other was unknown.  Information about the Lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Aphthous ulcer, Drug interaction, Platelet count increased, Tongue discolouration, Tongue ulceration
Clinical narrative: Tongue sore; the doctor felt like the hydroxyurea and the vaccine were sort of fighting each other; pulse and blood pressure increased; pulse and blood pressure increased; Welts on his tongue; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received bnt162b2 (BNT162B2,Manufacturer Pfizer-BioNTech) via an unspecified route of administration in arm left, at single dose, for COVID-19 immunisation: 1st dose on 19Feb2021 at 13:30 (Lot Number: EN6200) and 2nd dose on 15Mar2021 at 14:30 (Lot Number: EN6208); hydroxyurea (unknown manufacturer), via an unspecified route of administration, from an unspecified date  and ongoing (for about 24 years), at 500 mg 2x/day (on Monday Wednesday and Friday ) and at 500 mg 1x/day (on the other days) for platelet count increased. Medical history included platelet count increased, heart rate increased. Concomitant medications included atenolol (unknown manufacturer) for approximately 15 years and hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA). The patient experienced pulse and blood pressure increased (medically significant) on Apr2021 with outcome of unknown, welts on his tongue (non-serious) on 20Feb2021 with outcome of unknown, tongue sore (non-serious) on an unspecified date with outcome of unknown. His doctor felt like the hydroxyurea and the vaccine were sort of fighting each other. The events pulse and blood pressure increased required emergency room visit on 19Apr2021 and 20Apr2021. All the events required physician office visit. The patient underwent lab tests and procedures which included blood pressure measurement: increased in Apr2021, blood pressure measurement: up to 181/91 on 20Apr2021, blood pressure measurement: 105/62 on 21Apr2021, blood pressure measurement: 111/64 on 21Apr2021, chest x-ray: nothing wrong in heart/lungs on 19Apr2021, chest x-ray: nothing wrong in heart/lungs on 20Apr2021, electrocardiogram: nothing wrong in heart/lungs on 19Apr2021, electrocardiogram: nothing wrong in heart/lungs on 20Apr2021, heart rate: increased in Apr2021, heart rate: 114 on 20Apr2021, heart rate: 69 on 21Apr2021, heart rate: 66 on 21Apr2021.  The action taken in response to the events  for hydroxyurea was permanently withdrawn on an unspecified date.  Therapeutic measures were taken as a result of welts on tongue and included treatment with lidocaine 2% viscous solution and 5 mg  Benadryl and 5 mg antacid mixed into a paste and puts on the welts and lisinopril tablet at 10 mg daily for blood pressure increased. The reporter stated that the welts went away but he could see they were still there at the edge of the surface, not gone away fully. Patient stated that he experienced the events with both doses of vaccine. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Urticaria
Clinical narrative: Tongue sore; the doctor felt like the hydroxyurea and the vaccine were sort of fighting each other; pulse and blood pressure increased; pulse and blood pressure increased; Welts on his tongue; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received bnt162b2 (BNT162B2,Manufacturer Pfizer-BioNTech) via an unspecified route of administration in arm left, at single dose, for COVID-19 immunisation: 1st dose on 19Feb2021 at 13:30 (Lot Number: EN6200) and 2nd dose on 15Mar2021 at 14:30 (Lot Number: EN6208); hydroxyurea (unknown manufacturer), via an unspecified route of administration, from an unspecified date  and ongoing (for about 24 years), at 500 mg 2x/day (on Monday Wednesday and Friday ) and at 500 mg 1x/day (on the other days) for platelet count increased. Medical history included platelet count increased, heart rate increased. Concomitant medications included atenolol (unknown manufacturer) for approximately 15 years and hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA). The patient experienced pulse and blood pressure increased (medically significant) on Apr2021 with outcome of unknown, welts on his tongue (non-serious) on 20Feb2021 with outcome of unknown, tongue sore (non-serious) on an unspecified date with outcome of unknown. His doctor felt like the hydroxyurea and the vaccine were sort of fighting each other. The events pulse and blood pressure increased required emergency room visit on 19Apr2021 and 20Apr2021. All the events required physician office visit. The patient underwent lab tests and procedures which included blood pressure measurement: increased in Apr2021, blood pressure measurement: up to 181/91 on 20Apr2021, blood pressure measurement: 105/62 on 21Apr2021, blood pressure measurement: 111/64 on 21Apr2021, chest x-ray: nothing wrong in heart/lungs on 19Apr2021, chest x-ray: nothing wrong in heart/lungs on 20Apr2021, electrocardiogram: nothing wrong in heart/lungs on 19Apr2021, electrocardiogram: nothing wrong in heart/lungs on 20Apr2021, heart rate: increased in Apr2021, heart rate: 114 on 20Apr2021, heart rate: 69 on 21Apr2021, heart rate: 66 on 21Apr2021.  The action taken in response to the events  for hydroxyurea was permanently withdrawn on an unspecified date.  Therapeutic measures were taken as a result of welts on tongue and included treatment with lidocaine 2% viscous solution and 5 mg  Benadryl and 5 mg antacid mixed into a paste and puts on the welts and lisinopril tablet at 10 mg daily for blood pressure increased. The reporter stated that the welts went away but he could see they were still there at the edge of the surface, not gone away fully. Patient stated that he experienced the events with both doses of vaccine. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Chest X-ray normal, Electrocardiogram normal, Glossodynia, Heart rate increased
Clinical narrative: Tongue sore; the doctor felt like the hydroxyurea and the vaccine were sort of fighting each other; pulse and blood pressure increased; pulse and blood pressure increased; Welts on his tongue; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received bnt162b2 (BNT162B2,Manufacturer Pfizer-BioNTech) via an unspecified route of administration in arm left, at single dose, for COVID-19 immunisation: 1st dose on 19Feb2021 at 13:30 (Lot Number: EN6200) and 2nd dose on 15Mar2021 at 14:30 (Lot Number: EN6208); hydroxyurea (unknown manufacturer), via an unspecified route of administration, from an unspecified date  and ongoing (for about 24 years), at 500 mg 2x/day (on Monday Wednesday and Friday ) and at 500 mg 1x/day (on the other days) for platelet count increased. Medical history included platelet count increased, heart rate increased. Concomitant medications included atenolol (unknown manufacturer) for approximately 15 years and hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA). The patient experienced pulse and blood pressure increased (medically significant) on Apr2021 with outcome of unknown, welts on his tongue (non-serious) on 20Feb2021 with outcome of unknown, tongue sore (non-serious) on an unspecified date with outcome of unknown. His doctor felt like the hydroxyurea and the vaccine were sort of fighting each other. The events pulse and blood pressure increased required emergency room visit on 19Apr2021 and 20Apr2021. All the events required physician office visit. The patient underwent lab tests and procedures which included blood pressure measurement: increased in Apr2021, blood pressure measurement: up to 181/91 on 20Apr2021, blood pressure measurement: 105/62 on 21Apr2021, blood pressure measurement: 111/64 on 21Apr2021, chest x-ray: nothing wrong in heart/lungs on 19Apr2021, chest x-ray: nothing wrong in heart/lungs on 20Apr2021, electrocardiogram: nothing wrong in heart/lungs on 19Apr2021, electrocardiogram: nothing wrong in heart/lungs on 20Apr2021, heart rate: increased in Apr2021, heart rate: 114 on 20Apr2021, heart rate: 69 on 21Apr2021, heart rate: 66 on 21Apr2021.  The action taken in response to the events  for hydroxyurea was permanently withdrawn on an unspecified date.  Therapeutic measures were taken as a result of welts on tongue and included treatment with lidocaine 2% viscous solution and 5 mg  Benadryl and 5 mg antacid mixed into a paste and puts on the welts and lisinopril tablet at 10 mg daily for blood pressure increased. The reporter stated that the welts went away but he could see they were still there at the edge of the surface, not gone away fully. Patient stated that he experienced the events with both doses of vaccine. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Laboratory test abnormal, Urticaria
Clinical narrative: Tongue sore; the doctor felt like the hydroxyurea and the vaccine were sort of fighting each other; pulse and blood pressure increased; pulse and blood pressure increased; Welts on his tongue; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received bnt162b2 (BNT162B2,Manufacturer Pfizer-BioNTech) via an unspecified route of administration in arm left, at single dose, for COVID-19 immunisation: 1st dose on 19Feb2021 at 13:30 (Lot Number: EN6200) and 2nd dose on 15Mar2021 at 14:30 (Lot Number: EN6208); hydroxyurea (unknown manufacturer), via an unspecified route of administration, from an unspecified date  and ongoing (for about 24 years), at 500 mg 2x/day (on Monday Wednesday and Friday ) and at 500 mg 1x/day (on the other days) for platelet count increased. Medical history included platelet count increased, heart rate increased. Concomitant medications included atenolol (unknown manufacturer) for approximately 15 years and hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA). The patient experienced pulse and blood pressure increased (medically significant) on Apr2021 with outcome of unknown, welts on his tongue (non-serious) on 20Feb2021 with outcome of unknown, tongue sore (non-serious) on an unspecified date with outcome of unknown. His doctor felt like the hydroxyurea and the vaccine were sort of fighting each other. The events pulse and blood pressure increased required emergency room visit on 19Apr2021 and 20Apr2021. All the events required physician office visit. The patient underwent lab tests and procedures which included blood pressure measurement: increased in Apr2021, blood pressure measurement: up to 181/91 on 20Apr2021, blood pressure measurement: 105/62 on 21Apr2021, blood pressure measurement: 111/64 on 21Apr2021, chest x-ray: nothing wrong in heart/lungs on 19Apr2021, chest x-ray: nothing wrong in heart/lungs on 20Apr2021, electrocardiogram: nothing wrong in heart/lungs on 19Apr2021, electrocardiogram: nothing wrong in heart/lungs on 20Apr2021, heart rate: increased in Apr2021, heart rate: 114 on 20Apr2021, heart rate: 69 on 21Apr2021, heart rate: 66 on 21Apr2021.  The action taken in response to the events  for hydroxyurea was permanently withdrawn on an unspecified date.  Therapeutic measures were taken as a result of welts on tongue and included treatment with lidocaine 2% viscous solution and 5 mg  Benadryl and 5 mg antacid mixed into a paste and puts on the welts and lisinopril tablet at 10 mg daily for blood pressure increased. The reporter stated that the welts went away but he could see they were still there at the edge of the surface, not gone away fully. Patient stated that he experienced the events with both doses of vaccine. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Headache, Heart rate, Heart rate increased
Clinical narrative: stroking; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW01B1/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 (at the age of 67 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included ongoing hypertension (HTN) and COVID-19 on an unspecified date. The patient had known allergies to ciprofloxacin (CIPRO), latex and iodine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Apr2021 at 12:00AM, the patient reported that after having her first vaccine on 19Apr2021, the next morning her blood pressure went up to 210/110 and HR 130 with a pounding headache and reported "thought I was stroking". The patient received treatment for these events which included extra medicine: an extra dose of losartan, clonopin and two acetaminophen (TYLENOL) and slept 24 hours. The outcome of the events blood pressure went up, heart rate increased, headache and "thought I was stroking" was recovering. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported events and  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) 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.