chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood test, Bronchitis, Cluster headache, Computerised tomogram
Clinical narrative: Cluster headache; Bronchitis; UTI infection; sinus infection; Tremors in my hand, It's gotten worse; Lost over 15 pounds in three and a half weeks; This is a spontaneous report received from a contactable consumer. A 55-year-old female consumer (patient) reported for herself that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration in left arm on 28Jul2021 at 15:02 (at the age of 55-year-old) for COVID-19 immunisation. Relevant medical history included fibromyalgia, bipolar disorder and bronchitis. Concomitant medications included alprazolam (XANAX) for anxiety 1mg tablets 4 times a day then 3 times a day, gabapentin for a condition that she had in her legs (a fissure type, fissure balls), oxcarbazepine 300mg 1 and a half in the morning, first and a half in the evening and then first at the bedtime for bipolar disorder, salbutamol (ALBUTEROL) as rescue inhaler and hydrocodone bitartrate/paracetamol (HYDROCODONE/ACETAMINOPHEN) for 15 years 4 times a day then 3 times a day as needed. The patient was also taking five different medications for fibromyalgia and 'Flexural' (to be clarified) tablet at 10 milligrams tab, 3 times a day for severe muscular pain. The patient had a cluster headache that has not get rid of for three and half week. She also had  UTI infection, a sinus infection and bronchitis (new occurrence, not an aggravation of the medical history). The patient had a nebulized machine. She lost over 15 pounds in three and a half weeks and started having tremors in her hand. The patient was doing breathing treatment at home, she was on Azithromycin 250 milligrams tablet, take one by mouth daily for 10 days and Prednisone20 milligrams tablet, take one by mouth daily for 10 days. The cluster headache started within 24 hours the UTI was with started within 42 hours with the sinus infection on top. Headache was serious as causing hospitalization. Because of bronchitis the patient was on Flovent, helping her lungs to open (2 puffs usually once in the morning and then 12 hours later) and Flonase to try and keep her nose from the infection when she cannot breath. The patient did blood work earlier to check cholesterol, she also had CAT scan, MRI and ultrasound (no results provided). COVID test on 23Aug2021 was negative. Tremor was not resolved, outcome for the other events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, SARS-CoV-1 test, Sinusitis, Tremor, Ultrasound scan
Clinical narrative: Cluster headache; Bronchitis; UTI infection; sinus infection; Tremors in my hand, It's gotten worse; Lost over 15 pounds in three and a half weeks; This is a spontaneous report received from a contactable consumer. A 55-year-old female consumer (patient) reported for herself that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration in left arm on 28Jul2021 at 15:02 (at the age of 55-year-old) for COVID-19 immunisation. Relevant medical history included fibromyalgia, bipolar disorder and bronchitis. Concomitant medications included alprazolam (XANAX) for anxiety 1mg tablets 4 times a day then 3 times a day, gabapentin for a condition that she had in her legs (a fissure type, fissure balls), oxcarbazepine 300mg 1 and a half in the morning, first and a half in the evening and then first at the bedtime for bipolar disorder, salbutamol (ALBUTEROL) as rescue inhaler and hydrocodone bitartrate/paracetamol (HYDROCODONE/ACETAMINOPHEN) for 15 years 4 times a day then 3 times a day as needed. The patient was also taking five different medications for fibromyalgia and 'Flexural' (to be clarified) tablet at 10 milligrams tab, 3 times a day for severe muscular pain. The patient had a cluster headache that has not get rid of for three and half week. She also had  UTI infection, a sinus infection and bronchitis (new occurrence, not an aggravation of the medical history). The patient had a nebulized machine. She lost over 15 pounds in three and a half weeks and started having tremors in her hand. The patient was doing breathing treatment at home, she was on Azithromycin 250 milligrams tablet, take one by mouth daily for 10 days and Prednisone20 milligrams tablet, take one by mouth daily for 10 days. The cluster headache started within 24 hours the UTI was with started within 42 hours with the sinus infection on top. Headache was serious as causing hospitalization. Because of bronchitis the patient was on Flovent, helping her lungs to open (2 puffs usually once in the morning and then 12 hours later) and Flonase to try and keep her nose from the infection when she cannot breath. The patient did blood work earlier to check cholesterol, she also had CAT scan, MRI and ultrasound (no results provided). COVID test on 23Aug2021 was negative. Tremor was not resolved, outcome for the other events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Weight decreased
Clinical narrative: Cluster headache; Bronchitis; UTI infection; sinus infection; Tremors in my hand, It's gotten worse; Lost over 15 pounds in three and a half weeks; This is a spontaneous report received from a contactable consumer. A 55-year-old female consumer (patient) reported for herself that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration in left arm on 28Jul2021 at 15:02 (at the age of 55-year-old) for COVID-19 immunisation. Relevant medical history included fibromyalgia, bipolar disorder and bronchitis. Concomitant medications included alprazolam (XANAX) for anxiety 1mg tablets 4 times a day then 3 times a day, gabapentin for a condition that she had in her legs (a fissure type, fissure balls), oxcarbazepine 300mg 1 and a half in the morning, first and a half in the evening and then first at the bedtime for bipolar disorder, salbutamol (ALBUTEROL) as rescue inhaler and hydrocodone bitartrate/paracetamol (HYDROCODONE/ACETAMINOPHEN) for 15 years 4 times a day then 3 times a day as needed. The patient was also taking five different medications for fibromyalgia and 'Flexural' (to be clarified) tablet at 10 milligrams tab, 3 times a day for severe muscular pain. The patient had a cluster headache that has not get rid of for three and half week. She also had  UTI infection, a sinus infection and bronchitis (new occurrence, not an aggravation of the medical history). The patient had a nebulized machine. She lost over 15 pounds in three and a half weeks and started having tremors in her hand. The patient was doing breathing treatment at home, she was on Azithromycin 250 milligrams tablet, take one by mouth daily for 10 days and Prednisone20 milligrams tablet, take one by mouth daily for 10 days. The cluster headache started within 24 hours the UTI was with started within 42 hours with the sinus infection on top. Headache was serious as causing hospitalization. Because of bronchitis the patient was on Flovent, helping her lungs to open (2 puffs usually once in the morning and then 12 hours later) and Flonase to try and keep her nose from the infection when she cannot breath. The patient did blood work earlier to check cholesterol, she also had CAT scan, MRI and ultrasound (no results provided). COVID test on 23Aug2021 was negative. Tremor was not resolved, outcome for the other events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Had the first dose of the Pfizer Vaccine; Came down with Covid; This is a spontaneous report from a non-contactable consumer (patient's wife) from a Pfizer-sponsored program. This is the second case out of two cases in which the reporter is reporting for her husband. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: unknown), via an unspecified route of administration on 02Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Reportedly, the reporter and her husband had the first dose of the Pfizer Vaccine on 02Aug2021, and on 10Aug2021, they both came down with Covid, 8 days after. So, they were out of quarantine on the 22Aug2021 (22nd of this month) and now they want to go get their second dose, but the doctor told them that they have to wait 90 days. The patient underwent lab tests and procedures which included Covid Test: came down with covid on 10Aug2021. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101106375 Same reporter/drug/event, different patient.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Throat tightness
Clinical narrative: Anaphylactic reaction; light-headed; her throat started to get tight and close on her; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 18Aug2021 10:15 (Lot Number: EW0217) at age of 62-years-old as dose 1, single for COVID-19 immunisation.  Medical history included Asymmetric and Cancer on face, known allergies: yes. No other vaccine in four weeks. There were other medications in two weeks.  The patient felt light-headed, and then her throat started to get tight and close on her, had an Anaphylactic reaction on 18Aug2021 10:45 AM. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events included Epinephrine injection, Benadryl and Prednisone. The outcome of the events was recovered in Aug2021. There was no COVID prior vaccination. No COVID tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported for himself that a 28-years-old male patient received both dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was fully vaccinated with Pfizer COVID-19 vaccine and still tested positive for COVID-19. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, SARS-CoV-2 test, Tinnitus
Clinical narrative: hearing loss; Bilateral tinnitus; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on unknown date 18:30 (Lot Number: EK9231) as single dose, dose 2 via an unspecified route of administration, administered in right arm on unknown date (Lot Number: EL3249) as single dose for covid-19 immunisation. Medical history included pituitary micro adenoma; known allergies: sulfa. No history of hearing loss, no family history, no occupational/environmental history for hearing loss. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included bupropion, Hormone Replacement Therapy. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient received BNT162B2 on 28Dec2020 (unknown it was the date of the first dose or the second dose). The patient experienced bilateral tinnitus, had an audiogram which revealed moderate to severe sensorineural hearing loss (with left ear moderate and right ear severe) on 30Dec2020. The patient was not pregnant, not pregnant at time of vaccination. The events resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient received treatment as audiogram for the events. Covid-19 PCR (blood test) on 24Dec2020: Negative. Since the vaccination, the patient had been tested for COVID-19. Outcome of the events was not recovered. This report assessed a serious, disability.; Sender's Comments: Based on current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Hearing loss and Tinnitus. The case will be reassessed further upon receipt of additional information.  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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Hypersomnia, Memory impairment
Clinical narrative: Short term memory; brain fog; sleeping a lot; out of breath; This is a spontaneous report from a non-contactable consumer reported for himself. This 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC 59267-1000-01) via unspecified route of administration on 14Aug2021 01:00 AM at the age of 79 years old at single dose for COVID-19 immunization. Medical history included patient was diagnosed with COVID-19 prior to vaccination. No known allergies. Concomitant medications included triamterene, HCTZ. The patient experienced short term memory, brain fog, sleeping a lot, out of breath on 16Aug2021 with outcome of not recovered. Since the vaccination, the patient has not been tested for COVID-19.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Increase heart rate; This is a spontaneous report from a contactable physician  received via a sales representative.     A 13-years-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization.  Relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced increase heart rate serious for hospitalization with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate increased, Hypoaesthesia, Loss of consciousness
Clinical narrative: I felt like I was going to pass out; There was no way I could stand up without passing out; I had two more episodes like that; My heart rate was probably, it instantly, probably tripled; Skin tingling; Face was numb; Hands and feet were numb; I felt like I was having a heart attack; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration in left arm on an unspecified date, at 44 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Seventeen minutes after he received his first shot, he had "his heart rate was probably, it instantly, probably tripled and he felt like he was going to pass out, skin tingling, hands and feet were numb, face was numb. There was no way he could stand up without passing out, they picked him up at pharmacy and he had two more episodes like that within the next 15 minutes but they were not quite as intense, but he felt like he was having a heart attack". The patient asked if he could take the second vaccine dose. The patient stated he just took paracetamol (TYLENOL) the first two days and 'then he was good, afterwards". The reported events resolved on an unknown date.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: I felt like I was going to pass out; There was no way I could stand up without passing out; I had two more episodes like that; My heart rate was probably, it instantly, probably tripled; Skin tingling; Face was numb; Hands and feet were numb; I felt like I was having a heart attack; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration in left arm on an unspecified date, at 44 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Seventeen minutes after he received his first shot, he had "his heart rate was probably, it instantly, probably tripled and he felt like he was going to pass out, skin tingling, hands and feet were numb, face was numb. There was no way he could stand up without passing out, they picked him up at pharmacy and he had two more episodes like that within the next 15 minutes but they were not quite as intense, but he felt like he was having a heart attack". The patient asked if he could take the second vaccine dose. The patient stated he just took paracetamol (TYLENOL) the first two days and 'then he was good, afterwards". The reported events resolved on an unknown date.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Vertigo
Clinical narrative: Vertigo persisted daily for 4 months; This is a spontaneous report from a contactable other hcp.     A 43-years-old female patient received bnt162b2 (BNT162B2 BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 14:45 as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. It was Reported that, the patient experienced vertigo persisted daily for 4 months on Jan2021 with outcome of recovered on 30May2021. The patient underwent lab tests and procedures which included biopsy breast: negative on 06Jan2021.  Follow-Up (30Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Basedow's disease, Blood test
Clinical narrative: Very High Alt, and AST levels; Very High Alt, and AST levels; August 18, dx with Graves Disease; fatigue; weakness; rapid heart rate; breathlessness; May began losing weight; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Provided) via an unspecified route of administration at left arm on 03Mar2021 09:00 (at the age of 75-year-old) as dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Provided) via an unspecified route of administration at left arm on 11Feb2021 09:00 (at the age of 75-year-old) as dose 1, single for COVID-19 immunisation. Medical history included High cholesterol, high blood pressure, gastric reflux and concomitant medication included lisinopril, atorvastatin, calcium, vitamin D and vitamin B. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did have COVID prior to vaccination and it was no COVID tested post vaccination. It was reported that Jan2021 had physical exam with blood work -all tests were within normal range. In May began losing weight, June2021 began experiencing fatigue, weakness, rapid heart rate, and breathlessness. 18Aug2021, dx with Graves Disease and Very High Alt, and AST levels. The patient underwent lab tests and procedures which included alanine aminotransferase increased: very high on 18Aug2021, aspartate aminotransferase increased: very high on 18Aug2021, blood test: normal on Jan2021, heart rate: rapid on Jun2021, physical examination: normal on Jan2021. The events were considered as serious disability or permanent damage. Patient visits physician office for the events and treatment received for the events. Outcome of events was not recovered.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate, Heart rate increased, Physical examination
Clinical narrative: Very High Alt, and AST levels; Very High Alt, and AST levels; August 18, dx with Graves Disease; fatigue; weakness; rapid heart rate; breathlessness; May began losing weight; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Provided) via an unspecified route of administration at left arm on 03Mar2021 09:00 (at the age of 75-year-old) as dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Provided) via an unspecified route of administration at left arm on 11Feb2021 09:00 (at the age of 75-year-old) as dose 1, single for COVID-19 immunisation. Medical history included High cholesterol, high blood pressure, gastric reflux and concomitant medication included lisinopril, atorvastatin, calcium, vitamin D and vitamin B. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did have COVID prior to vaccination and it was no COVID tested post vaccination. It was reported that Jan2021 had physical exam with blood work -all tests were within normal range. In May began losing weight, June2021 began experiencing fatigue, weakness, rapid heart rate, and breathlessness. 18Aug2021, dx with Graves Disease and Very High Alt, and AST levels. The patient underwent lab tests and procedures which included alanine aminotransferase increased: very high on 18Aug2021, aspartate aminotransferase increased: very high on 18Aug2021, blood test: normal on Jan2021, heart rate: rapid on Jun2021, physical examination: normal on Jan2021. The events were considered as serious disability or permanent damage. Patient visits physician office for the events and treatment received for the events. Outcome of events was not recovered.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Very High Alt, and AST levels; Very High Alt, and AST levels; August 18, dx with Graves Disease; fatigue; weakness; rapid heart rate; breathlessness; May began losing weight; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Provided) via an unspecified route of administration at left arm on 03Mar2021 09:00 (at the age of 75-year-old) as dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Provided) via an unspecified route of administration at left arm on 11Feb2021 09:00 (at the age of 75-year-old) as dose 1, single for COVID-19 immunisation. Medical history included High cholesterol, high blood pressure, gastric reflux and concomitant medication included lisinopril, atorvastatin, calcium, vitamin D and vitamin B. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did have COVID prior to vaccination and it was no COVID tested post vaccination. It was reported that Jan2021 had physical exam with blood work -all tests were within normal range. In May began losing weight, June2021 began experiencing fatigue, weakness, rapid heart rate, and breathlessness. 18Aug2021, dx with Graves Disease and Very High Alt, and AST levels. The patient underwent lab tests and procedures which included alanine aminotransferase increased: very high on 18Aug2021, aspartate aminotransferase increased: very high on 18Aug2021, blood test: normal on Jan2021, heart rate: rapid on Jun2021, physical examination: normal on Jan2021. The events were considered as serious disability or permanent damage. Patient visits physician office for the events and treatment received for the events. Outcome of events was not recovered.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Menstruation irregular
Clinical narrative: Blood pressure went up, usual BP is 128/85 and had 147/100; Period became irregular, went from happening every 29 days to being completely off and unexpected; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 21-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EW0171), via an unspecified route of administration, administered in left arm on 03May2021 at 15:00 (age at the time of vaccination was 21 years) as dose 2, single for covid-19 immunisation at hospital. Medical history included, covid-19 from an unknown date and unknown if ongoing (the patient had COVID prior vaccination) and birth control from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norethisterone acetate (LOESTRIN) taken for birth control, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient was previously administered bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EW0162), via an unspecified route of administration, administered in left arm on 14Apr2021 at 16:15 (age at the time of vaccination was 21 years) as dose 1, single for covid-19 immunisation at hospital. It was reported that no other vaccine was administered to patient in four weeks. On 10May2021, the patient(s) blood pressure went up, usual bp was 128/85 and had 147/100, period became irregular, went from happening every 29 days to being completely off and unexpected. Also her blood pressure went up, usual BP is 128/85 and had 147/100 for a full month before it went away and came back down to normal levels. On 10May2021 the patient underwent lab tests and procedures which included blood pressure measurement: 147/100 (Usual BP is 128/85). The patient was not tested for COVID post vaccination. No treatment was received for AE. It was reported that the AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Eye swelling, Facial pain, Pain in extremity, Swelling face
Clinical narrative: My arm hasn't hurt, only if I lift it a lot; under my eye it's so swollen that it is oozing water / it was a build of water from a sore from her face and not water coming from her eye; Today I woke up with a swollen face/very evident; hives; under my eye it's so swollen that it is oozing water; small blood vessels in my left eyes that burst/some blood vessels in her right eye burst; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date, NDC number: unknown), via an unspecified route of administration, administered in left arm on 25Aug2021 (age at vaccination was 48 years) as DOSE 1, SINGLE for covid-19 immunisation. No medical history reported. Concomitant medication was not reported, but patient stated that she was only taking her menopause pill. It was a vitamin that patient has been taking for years. Does not wish to add at this time. Does not think that it is related to this. On an unspecified date the patient was experienced my arm hasn't hurt, only if I lift it a lot and under my eye it's so swollen that it is oozing water / it was a build of water from a sore from her face and not water coming from her eye; On 25Aug2021, experienced some blood vessels in her right eye burst; On 26Aug2021, experienced face is swollen, hives, under my eye it's so swollen that it is oozing water. The report received as, yesterday, the patient received the Pfizer Covid 19 vaccine and today patient has a reaction to it. Today, patient woke up with a swollen face and small blood vessels in eyes that burst. What worries patient most are the hives and the swollen face, it was very evident. The patient was little worried, this hadn't happened to patient before. The patient arm hasn't hurt, only if patient lift it a lot, but patient face was swollen and under patient eye it's so swollen that it was oozing water. The patient washing the face normally and patient going to put on sunscreen. Later confirmation got that it was a build of water from a sore from her face and not water coming from her eye. Clarified that beneath both eyes are swollen. Treatment was reported as none. No investigation assessment was done. Outcome of the events pain in arm and facial pain was unknown and remaining events were not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: My arm hasn't hurt, only if I lift it a lot; under my eye it's so swollen that it is oozing water / it was a build of water from a sore from her face and not water coming from her eye; Today I woke up with a swollen face/very evident; hives; under my eye it's so swollen that it is oozing water; small blood vessels in my left eyes that burst/some blood vessels in her right eye burst; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date, NDC number: unknown), via an unspecified route of administration, administered in left arm on 25Aug2021 (age at vaccination was 48 years) as DOSE 1, SINGLE for covid-19 immunisation. No medical history reported. Concomitant medication was not reported, but patient stated that she was only taking her menopause pill. It was a vitamin that patient has been taking for years. Does not wish to add at this time. Does not think that it is related to this. On an unspecified date the patient was experienced my arm hasn't hurt, only if I lift it a lot and under my eye it's so swollen that it is oozing water / it was a build of water from a sore from her face and not water coming from her eye; On 25Aug2021, experienced some blood vessels in her right eye burst; On 26Aug2021, experienced face is swollen, hives, under my eye it's so swollen that it is oozing water. The report received as, yesterday, the patient received the Pfizer Covid 19 vaccine and today patient has a reaction to it. Today, patient woke up with a swollen face and small blood vessels in eyes that burst. What worries patient most are the hives and the swollen face, it was very evident. The patient was little worried, this hadn't happened to patient before. The patient arm hasn't hurt, only if patient lift it a lot, but patient face was swollen and under patient eye it's so swollen that it was oozing water. The patient washing the face normally and patient going to put on sunscreen. Later confirmation got that it was a build of water from a sore from her face and not water coming from her eye. Clarified that beneath both eyes are swollen. Treatment was reported as none. No investigation assessment was done. Outcome of the events pain in arm and facial pain was unknown and remaining events were not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Dyspnoea, Fatigue, Poor quality sleep
Clinical narrative: shortness of breath appears; I felt burning in the heart area; I have constant pain in the chest, sometimes lower, sometimes stronger; I feel constant fatigue, tiredness; I don't have enough sleep; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EW0186, expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 02Aug2021 (age at vaccination: 42-years-old) as dose 2, single for covid-19 immunisation. The patient did not have any other medical history or known allergies. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EW0181, expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 23Jun2021 (age at vaccination: 42-years-old) as dose 1, single for covid-19 immunisation. On 02Aug2021, patient felt burning in the heart area which lasted for 2-3 weeks, after that he had constant pain in the chest, sometimes lower, sometimes stronger. After the second shot, he felt constant fatigue, tiredness as he did not have enough sleep. Often, when walking, shortness of breath appeared, and chest pain increased. Patient did not receive any treatment for the events. He did not have covid prior vaccination and not tested for covid post vaccination. Patient did not have other vaccine in four weeks and not received other medications in two weeks. The outcome of the event burning in the heart area was recovered and the other events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She states that she and a few of her coworkers all tested positive after they had already had the first dose of the Pfizer COVID 19 vaccination; She states that she and a few of her coworkers all tested positive after they had already had the first dose of the Pfizer COVID 19 vaccination; This is a spontaneous report from a contactable consumer or other non HCP. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, she and a few of her coworkers all tested positive on an unspecified date after they had already had the first dose of the Pfizer COVID 19 vaccination. She and one other coworker have both tested negative now. She would like to know if she needed to start the series over again or if she can receive her second dose of the vaccine today or not as she was due to take her second vaccination today but she was informed by her coworker that if you tested positive after getting the first dose, you were not supposed to get the second dose and patient was trying to figure it out. The patient underwent lab tests and procedures which included SARS-COV-2 test which was positive on an unspecified date; she and one other coworker have both tested negative now. The outcome of event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Hyperhidrosis, Pruritus
Clinical narrative: Headache; itching head to toe; sweating like crazy; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer reported for herself.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EW0196), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EW0198), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization.  Medical history included panic attack and depression from an unknown date and unknown if ongoing. The concomitant medications were not reported. On an unspecified date, the patient experienced itching head to toe, sweating like crazy and has a headache nearly 24 hours a day everyday. The patient stated that ever since she got the vaccines, she has been having headaches. The patient took the two injections and has been going to the doctor ever since; having to pay copays and even went to the hospital. The nurse at the insurance company thought it was a hormone imbalance because the patient was not having her period but she has not had her period in 18 years since she had an ablation. The patient mentioned that she had to quit her job as an infant caretaker and now she has no benefits. They can't figure out where the headache, itching sweating is coming from. The patient stated that she is going crazy. The patient reported that they weaned her off of all her antidepressants or panic attack pills. They tried an itch medication that does not work; the patient already tried all the over the counter antihistamines. The patient underwent lab tests and procedures which included Cat Scan of her head- can't figure out where the headache. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Joint stiffness, Movement disorder, Urinary tract infection
Clinical narrative: UTI; Joint Stiffness and Pain; Joint Stiffness and Pain; couldn't get out of the chair; reactive inflammatory arthritis from the vaccine; This is a spontaneous report from a contactable consumer. An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was Unknown) via an unspecified route of administration on 05Mar2021 (at the age of 80-year-old) as dose 2, single for COVID Prophylaxis. Patient had no medical history and no concomitant medications. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12Feb2021 (at the age of 80-year-old) as dose 1, single for COVID Prophylaxis. It was reported that the patient come to the ER with really bad joint stiffness and pain, reactive inflammatory arthritis that started a little after her first vaccine. It was stated that in 2021, the joint stiffness and pain, reactive inflammatory arthritis got a lot worsened after her second dose. Caller stated her doctor tried her going on a Prednisone burst and taper which helped but when she stopped the Prednisone it got worse and she had to call an ambulance because she couldn't get out of the chair in 2021. On 25Aug2021, the patient had UTI (urinary tract infection) and the patient was on Solumedrol IV, Antibiotic Levofloxacin for a UTI that they started treating. On the same date (25Aug2021), the patient was hospitalized which was ongoing (at the time of reporting, the patient was in the hospital) for the events of UTI, joint stiffness and pain, reactive inflammatory arthritis and couldn't get out of the chair. Caller stated that the physician put down the disease, reactive inflammatory arthritis from the vaccine in 2021. The patient was visited Physician Office for all events except UTI. On 25Aug2021, the patient visited Emergency Room for all reported events. Relevant tests were none. Outcome of the event UTI was unknown and the other events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Deafness, Product administered at inappropriate site, SARS-CoV-2 test
Clinical narrative: Lost hearing in left ear only in early june 2021. Currenty not able to hear as before; Anatomical Location: Leg Right; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 66-years-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in right leg on 24Mar2021 (age at vaccination was 66 years) as dose number unknown, single for COVID-19 immunization. The patient had known allergy to Penicillin from an unknown date. The patient did not have any other medical history. The patient did not receive any concomitant medications or other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 04Jun2021, the patient lost hearing in left ear only in early Jun2021. Currently not able to hear as before. No treatment was received for the event deafness. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests which included blood test: negative and COVID-19 test: negative on 20Aug2021. The device date was reported as 26Aug2021. The outcome of the event deafness was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain
Clinical narrative: Severe chest pain, particularly the heart.; Severe chest pain, particularly the heart.; This is a spontaneous report from a Non-contactable Other HCP (patient herself). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 19Aug2021 13:15 (age at vaccination: 25-years) as dose number unknown, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patients medical history included covid-19 prior to vaccination, from an unspecifed date and unknown if ongoing. Concomitant medications were not reported. The patient was not tested for covid post vaccination. On 24Aug2021, patient experienced severe chest pain, particularly the heart. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment regimen was given as a result of the adverse events. The outcome of event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, SARS-CoV-2 test, Skin graft, Thrombosis, Wound
Clinical narrative: Large bruise followed by clotting event; Large bruise followed by clotting event; Wound care; Skin grafting; This is a spontaneous report from a contactable other hcp (patient). A 21-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in arm on 2021 (Batch/Lot Number: EL1283) (at the age of 21-years-old) as SINGLE for covid-19 immunization at Workplace clinic. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in left arm on 14Jan2021 (Batch/Lot number: EL0140) (at the age of 21-years-old) as SINGLE for covid-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had no known allergies. Patient medical history was reported as no. Patient concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) and pseudoephedrine (PSEUDOFED) and hair/nails supplement; all taken for an unspecified indication, start and stop date were not reported for any. The patient did not receive any other vaccines within 4 weeks. On 06Feb2021, the patient experienced large bruise followed by clotting event within a month post vaccination that leads to tissue removal, wound care and skin grafting. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. It was reported that the patient was hospitalized for all of the events for 2 days from 2021 to 2021. The patient underwent lab tests and procedures which included sars-cov-2 test (test type: nasal Swab) which was found to be negative on 05Mar2021.The patient was provided with surgery, wound care, lovenox shots as a treatment received. The reporter considered the event as serious (Requires inpatient or prolongation of hospitalization). The outcome of events was recovered with lasting effects.   Information on the lot/batch number has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles; pain from shingles/pain from them was much worst.; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 89-year-old male patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 (Batch/Lot Number: EN6ZCI) as DOSE 2, SINGLE (at the age of 88-year-old) for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive other products. Historical vaccine included first dose of bnt162b2 on 30Jan2021 (Batch/lot number: ELGZ65, Unknown dosage shot to her right arm) for covid-19 immunisation. The patient experienced shingles and pain from shingles/pain from them was much worst on an unknown date of 2021. The patient stated that they shingles killing her and the pain was really bad. Stated that it has been one month since she was told that she had the shingles. Stated that she went to emergency room on 30Jul2021 due to shingles. The reporter stated that nurse stated that the shingles were lighter. The pain from them was much worst. The patient prescribed with prednisone twice and a low dose of Gabapentin. The patient not taken Gabapentin yet as she stated that if the other dose of prednisone helps her then she will not take Gabapentin. The doctor gave her some creamy stuff and she was doing that too. Therapeutic measures were taken as a result of the events. The outcome of events reported as not recovered.  Follow-up attempts are completed. No further information is expected.