chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort
Clinical narrative: With in 30 minutes of receiving my 1st does of the vaccine my mouth started burning like it was on fire and turned white; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FC3183), via an unspecified route of administration, administered in Arm Right on 03Sep2021 16:30 at the age of 57-year-old as dose 1, single for covid-19 immunisation from pharmacy or drug store. Medical history included Sjogren's syndrome, Raynaud's, Chilblains, chronic venous insufficiency, osteoarthritis and allergies to many antibiotics, tetanus shot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. Concomitant medication included vitamin b complex (VITAMIN B COMPLEX) and clonazepam (CLONAZEPAM) taken for an unspecified indication, start and stop date were not reported. The patient previously took antibiotics and experienced drug hypersensitivity, tetanus toxoid for immunisation and experienced allergy to vaccine.  On 03Sep2021 17:00 (within 30 minutes of receiving first does of the vaccine) patient experienced mouth started burning like it was on fire and turned white which ae resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The burning sensation has not stopped. Patient take a numbing mouthwash for the event that really doesnt help much. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with Covid 19; This is a spontaneous report from a contactable consumer (patient).  A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA7435 or FA7485) via an unspecified route of administration, in right arm on 03Aug2021 (at the age of 52-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included diabetes mellitus from an unknown date and unknown if ongoing. Reporter states he had been diabetic for years and years. The patient concomitant medication was not reported. Patient had not received any additional vaccines same date of the pfizer suspect. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Aug2021, the patient had been diagnosed with covid-19 a week after first dose of Pfizer COVID Vaccine. Event was considered as serious (hospitalization) by the reporter. The patient was hospitalized for diagnosed with covid-19 for 4 days. Reporter stated that the event resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included a result of sars-cov-2 test positive on an unspecified date in Aug2021. It was reported that he had testing done while he was hospitalized with COVID. The outcome of the event was recovered on an unspecified date in 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy, Vaccination failure
Clinical narrative: Testing positive for covid-19; Testing positive for covid-19; Pregnant; This is a spontaneous report from a contactable consumer (Patient). This consumer reported information for both mother and fetus/baby. This is a maternal report. A 32-years-old pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection; Lot Number: EP6955) dose 2 via intramuscular route of administration, administered in Arm Left on 26Mar2021 12:00 as dose 2, single and first dose of bnt162b2 (BNT162B2, solution for injection; Lot Number: EL3248) dose 1 via intramuscular route of administration, administered in Arm Left on 05Mar2021 13:00 as dose 1, single (At the age of 31-year) for covid-19 immunization. Medical history was not reported. Concomitant medication(s) included ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromium nicotinate, colecalciferol, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium hydroxide, manganese gluconate, nicotinamide, Phyto menadione, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, selenomethionine, sodium molybdate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTIVITAMIN FOR WOMEN) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 12Sep2021 07:00 the patient experienced testing positive for covid-19 on sept 13, 2021, and pregnant. The mother reported she became pregnant while taking bnt162b2. The mother was 28 Weeks pregnant at the onset of the event. The mother was due to deliver. On 13Sep2021 the patient underwent lab tests and procedures which included sars-cov-2 test result was positive, Nasal Swab. The outcome of the event testing positive for covid-19 was recovering for and it was unknown for the rest.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered at Public Health Clinic/Military facility, via an unspecified route in left arm on 18Aug2021 14:45 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient didn't receive any other vaccine in the 4 weeks prior to vaccination. She was not diagnosed with COVID-19 before vaccination and was not tested for COVID-19 post vaccination. The patient reported that, after the first vaccine dose, in Aug2021, she experienced a terrible headache for 3 days. The event outcome was unknown at the time of the report.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198197 Same reporter/vaccine, different dose/event
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of consciousness, Pallor, Somnolence
Clinical narrative: Passed out; Her lips were white; Slept all day and night; Fatigue; This is a spontaneous report from a contactable consumer (patient's mother)   A 15-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 11Sep2021 at 14:00 (Lot Number: 301358A), at the age of 15 years old, as 2nd single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. There were no prior vaccinations within 4 weeks of the BNT162b2 vaccination. Past drug vaccinations included the 1st BNT162b2 single dose (Lot: FA6780) administered on 22Jul2021 at about 10 am, in the left arm. The patient's mother stated that at 11am on 12Sep2021 her daughter woke up and came downstairs, then she saw stars and passed out. This lasted about a minute and then she came too, her lips were white when this happened. She was a lot better at the time of the reporting but after the passing out she slept all day and night. The reporter tried to wake her up to check on her but she kept sleeping. The patient also had fatigue on 12Sep2021 that at the time of the reporting was not all the way gone but the patient was better. The patient was treated with rest and liquids. The patient recovered from passing out and sleeping all day on 12Sep2021. The patient was recovering from fatigue. The outcome for pale lips was not specified. There was no need for a visit to Emergency Room, neither at the physician's office. According to the reporter the events were considered non-serious.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Loss of consciousness, Nausea
Clinical narrative: passed out / unconscious; convulsions; tired; chills; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered at Health Clinic, via an unspecified route in left arm on 08Sep2021 14:00 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm on 18Aug2021 14:45 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization, after which the patient experienced a terrible headache for 3 days. The patient didn't receive any other vaccine in the 4 weeks prior to vaccination. She was not diagnosed with COVID-19 before vaccination and was not tested for COVID-19 post vaccination. The patient reported that she was fine on the day of the second shot, but she woke up the following day very tired and with chills. After eating breakfast, she was overcome by nausea and dizziness and she passed out. She had convulsions while unconscious, so her husband called paramedics. All the events were reported to have occurred on 09Sep2021 at 09:00 and required Emergency room/department or urgent care. The events resolved on an unknown date after receiving treatment with ondansetron (ZOFRAN) for nausea, observation and unspecified tests.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: passed out / unconscious; convulsions; tired; chills; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered at Health Clinic, via an unspecified route in left arm on 08Sep2021 14:00 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm on 18Aug2021 14:45 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization, after which the patient experienced a terrible headache for 3 days. The patient didn't receive any other vaccine in the 4 weeks prior to vaccination. She was not diagnosed with COVID-19 before vaccination and was not tested for COVID-19 post vaccination. The patient reported that she was fine on the day of the second shot, but she woke up the following day very tired and with chills. After eating breakfast, she was overcome by nausea and dizziness and she passed out. She had convulsions while unconscious, so her husband called paramedics. All the events were reported to have occurred on 09Sep2021 at 09:00 and required Emergency room/department or urgent care. The events resolved on an unknown date after receiving treatment with ondansetron (ZOFRAN) for nausea, observation and unspecified tests.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Headache, Hypoaesthesia, Urticaria
Clinical narrative: Pains in my heart/ sharp pain like in your lung like a growing pain/piercing pain; Headache; Arms numb in and off first couple days; one hive on my face; This is a spontaneous report from a non-contactable consumer (patient herself).  A female patient of unknown age received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route, on unknown date at single dose for COVID-19 immunization. No relevant medical history and concomitant medications were provided. The patient stated that when she went to get her first dose of BNT162B2 the pharmacist pinched her arm when inserting the needle, caller seeking information if is this the correct way to administer. The patient also reported that she sat for 15 minutes in the pharmacy after and then when she left she sat in her car for 10 minutes more and felt sharp pain like in your lung like a growing pain, but that it was low in her uterus, piercing pain happened several times over that day. Also at that time she experienced headache that lasted just a few seconds.  Other side effects reported were: arms numb in and off first couple days, pains in my heart, felt similar as when I may have had COVID mildly before, period felt like it was going to start but it never did. These all went away. Then on day 6 and 7 really bad headache 2 and a half hours headaches. Caller also reports one hive on my face last one day and went away. She is scheduled to get her second shot in about 4 days. The patient had recovered from the events on unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out into a rash; This is a spontaneous report from a contactable physician (patient).   A 45-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 21Aug2021 between 10:00-11:00 AM (Lot Number: FC3180), at the age of 45 years old, as 1st single dose for COVID-19 immunisation. Medical history included allergy to many medications (unspecified). There were no concomitant medications. There were no prior vaccinations within 4 weeks from the 1st administration of BNT162b2. The patient reported that on 23Aug2021 she broke out into a rash. The patient was not sure if she was allergic to any of the ingredients in the vaccine. The patient had called her dermatologist and doctor but she did not visit any physician's office, nor went to ER. After a week, the rash went away. The patient got her 2nd dose of BNT162b2 on 11Sep2021 and rash re-appeared on 13Sep2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101199467 same reporter/patient, different dose/similar event
Sex: F
Vaccine: COVID19
Symptoms: Artery dissection, Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: 2 strokes in occipital lobe and dissection of artery; 2 strokes in occipital lobe and dissection of artery; This is a spontaneous report from a contactable consumer (patient) A 49-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6208) via an unspecified route of administration in Arm Left on 2021 as single dose for covid-19 immunisation.  Medical history included lupus, aplastic anemia (apls) and Raynauds; patient had unspecified allergies. Previously on 09Mar2021 (at 49 years) the patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: En6203) in Right arm for covid-19 immunisation.Concomitant medications included hydroxychloroquine; escitalopram oxalate (LEXAPRO); rivaroxaban (XARELTO) and vitamis, all taken for unspecified indication, start and stop date were not reported. Nasal Swab on 02Sep2021 was negative. The patient experienced 2 strokes in occipital lobe and dissection of artery on 07Aug2021 at 08:00 am. Patient was treated with Lovenox.Events results in Emergency room/department or urgent care and hospitalization for 4 days in Aug2021.Patient recovered with lasting effects on an unknown date in 2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: Rash and Blisters on arms and face; Rash and Blisters on arms and face; This is a spontaneous report from a contactable consumer (patient) . A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Fc3184), via an unspecified route of administration in Arm Left on 05Sep2021 (at 42 years) at 13:15 as single dose for covid-19 immunisation  .  The patient medical history was not reported. There were no concomitant medications.  Prior to vaccination the patient was not diagnosed with COVID-19; since the vaccination she has not been tested for COVID-19. On 08Sep2021 the patient experienced rash and blisters on arms and face. Events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse events included prednisone.Outcome of the event was recovering.No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I and my whole family came down with COVID. I was fully vaccinated; I and my whole family came down with COVID. I was fully vaccinated; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at dose 2, single and first dose at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient and whole family came down with COVID. Patient was fully vaccinated, and was able to take care of family while they were sick. Patient wrote to thank the company and also to protest the use of aborted fetal stem cells in the production of the vaccine. The outcome of the event was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Epistaxis, Faecaloma, Headache, Herpes zoster
Clinical narrative: Severe constipation and impaction; Severe constipation and impaction; Continual runny nose; Inflamed sinus passages which caused nose bleeds; Inflamed sinus passages which caused nose bleeds; Shingles outbreak in right nostril; Headache; Nausea; This is a spontaneous report from a contactable consumer (patient).   A 58-years-old female (not pregnant) patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 08Sep2021, at the age of 58 years old, as 2nd single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome with diarrhea, reflux disease (GERD), hypothyroidism, chronic shingles, and known allergies to sulfa, meperidine (DEMEROL), and amoxycillin. Past vaccination history included the 1st dose of BNt162b2 received on 18Aug2021 in the left arm, at the age of 58 years old. There were no other vaccinations within the 4 weeks prior to the 2nd dose of BNt162b2. The patient received unspecified concomitant drugs. The patient had not had COVID prior to vaccination and was not COVID tested post vaccination. On 09Sep2021, the patient experienced continuous runny nose, inflamed sinus passages which caused nose bleeds, shingles outbreak in right nostril, headache, nausea, and severe constipation and impaction. Treatment due to the events included valacyclovir (VALTREX), suppositories, Fleet Enema. The patient was recovering from the above-mentioned events.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rhinorrhoea, Sinusitis
Clinical narrative: Severe constipation and impaction; Severe constipation and impaction; Continual runny nose; Inflamed sinus passages which caused nose bleeds; Inflamed sinus passages which caused nose bleeds; Shingles outbreak in right nostril; Headache; Nausea; This is a spontaneous report from a contactable consumer (patient).   A 58-years-old female (not pregnant) patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 08Sep2021, at the age of 58 years old, as 2nd single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome with diarrhea, reflux disease (GERD), hypothyroidism, chronic shingles, and known allergies to sulfa, meperidine (DEMEROL), and amoxycillin. Past vaccination history included the 1st dose of BNt162b2 received on 18Aug2021 in the left arm, at the age of 58 years old. There were no other vaccinations within the 4 weeks prior to the 2nd dose of BNt162b2. The patient received unspecified concomitant drugs. The patient had not had COVID prior to vaccination and was not COVID tested post vaccination. On 09Sep2021, the patient experienced continuous runny nose, inflamed sinus passages which caused nose bleeds, shingles outbreak in right nostril, headache, nausea, and severe constipation and impaction. Treatment due to the events included valacyclovir (VALTREX), suppositories, Fleet Enema. The patient was recovering from the above-mentioned events.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac disorder, Cerebrovascular accident, Investigation
Clinical narrative: Stroke; AFib; a lot of heart things; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program via Regulatory Authority Support. A 74-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered at Movie theater, via an unspecified route in left arm on 18Feb2021, at 74 years of age, (Batch/Lot Number: EN6201) as single dose for COVID-19 immunization. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm on 28Jan2021, (Batch/Lot Number: EL9262) as single dose for COVID-19 immunization. The patient didn't receive any other vaccine within the 4 weeks previous to vaccination. Medical history included an unspecified neoplasm malignant and lymphoedema from cancer in her right arm, both from an unknown date and that's the reason why she can't receive shots in her right arm. The patient's concomitant medication included blood thinner. In Apr2021 the patient experienced stroke for which she was hospitalized from Apr2021 to an unknown date and it was determined she had atrial fibrillation (onset date unknown), assessed as medically significant and "a whole bunch of other things as well. She states she had just "a lot of heart things". The patient stated she was just trying to find out where she can get the third dose, as per her doctor's recommendation. She states she didn't have any problems with the first two shots, she is just concerned that she didn't get her third one. The patient stated she had tests done (unspecified). The events outcome was unknown at the time of the report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Cough, Fatigue, Hypersomnia, Illness
Clinical narrative: Spondylitis ankylosing aggravated; Ache; Sleep excessive; Cough; Fatigue; Illness; This is a Solicited report from FACILITATED COLLECT based on information received by Pfizer from Regulatory Authority (manufacturer control number: 21K-163-3976955-00. A contactable consumer (patient) reported that a 54-year-old male patient received bnt162b2 (Batch/Lot number was not reported), first dose intramuscular on 20Apr2021 at the age of 54-year-old as single dose, second dose intramuscular on 20May2021 at the age of 54-year-old as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, Solution for injection in pre-filled pen), subcutaneous from an unspecified date and ongoing, at unspecified dose for ankylosing spondylitis. The patient's medical history and concomitant medications were not reported. The patient experienced spondylitis ankylosing aggravated, ache, sleep excessive, cough, fatigue, illness in 2021. Solicited report from the Regulatory Authority by a consumer of an adult male with events of non-serious ankylosing spondylitis flare up, achiness, illness/fatigue/slept for 72 hours and cough with adalimumab (HUMIRA). There was no reported medical history. On unknown dates, the patient experienced ankylosing spondylitis flare up, achiness, illness/fatigue/slept for 72 hours and cough. Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect. On 20Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 20May2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. The action taken in response to the events for adalimumab was unknown. The outcome of events for cough was unknown, for other events was not resolved. The reporter's causality for the events of ankylosing spondylitis flare up and achiness with adalimumab was a reasonable possibility. The reporter's causality for the events of fatigue, slept for 72 hours, cough and was not provided. The reporter's causality for the event of illness with adalimumab was no reasonable possibility.   The reporter's assessment of the causal relationship of all events with the bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Spondylitis ankylosing aggravated, Ache, Sleep excessive, Cough, Fatigue, Illness and suspect drug BNT162B2 cannot be excluded.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Spondylitis ankylosing aggravated; Ache; Sleep excessive; Cough; Fatigue; Illness; This is a Solicited report from FACILITATED COLLECT based on information received by Pfizer from Regulatory Authority (manufacturer control number: 21K-163-3976955-00. A contactable consumer (patient) reported that a 54-year-old male patient received bnt162b2 (Batch/Lot number was not reported), first dose intramuscular on 20Apr2021 at the age of 54-year-old as single dose, second dose intramuscular on 20May2021 at the age of 54-year-old as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, Solution for injection in pre-filled pen), subcutaneous from an unspecified date and ongoing, at unspecified dose for ankylosing spondylitis. The patient's medical history and concomitant medications were not reported. The patient experienced spondylitis ankylosing aggravated, ache, sleep excessive, cough, fatigue, illness in 2021. Solicited report from the Regulatory Authority by a consumer of an adult male with events of non-serious ankylosing spondylitis flare up, achiness, illness/fatigue/slept for 72 hours and cough with adalimumab (HUMIRA). There was no reported medical history. On unknown dates, the patient experienced ankylosing spondylitis flare up, achiness, illness/fatigue/slept for 72 hours and cough. Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect. On 20Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 20May2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. The action taken in response to the events for adalimumab was unknown. The outcome of events for cough was unknown, for other events was not resolved. The reporter's causality for the events of ankylosing spondylitis flare up and achiness with adalimumab was a reasonable possibility. The reporter's causality for the events of fatigue, slept for 72 hours, cough and was not provided. The reporter's causality for the event of illness with adalimumab was no reasonable possibility.   The reporter's assessment of the causal relationship of all events with the bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Spondylitis ankylosing aggravated, Ache, Sleep excessive, Cough, Fatigue, Illness and suspect drug BNT162B2 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Cough, Drug ineffective, Headache
Clinical narrative: Dry cough; Throwing up; My stomach was not right for a couple days; Tested positive for Covid; Tested positive for Covid; Headache; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 2, SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Sep2021, the patient tested positive for covid. On 01Sep2021, patient had headache. On an unspecified date, the patient experienced dry cough, throwing up, my stomach was not right for a couple days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 03Sep2021. The outcome of the event tested positive for covid was unknown and other events outcome was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Dry cough; Throwing up; My stomach was not right for a couple days; Tested positive for Covid; Tested positive for Covid; Headache; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 2, SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Sep2021, the patient tested positive for covid. On 01Sep2021, patient had headache. On an unspecified date, the patient experienced dry cough, throwing up, my stomach was not right for a couple days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 03Sep2021. The outcome of the event tested positive for covid was unknown and other events outcome was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Pruritus, Rash
Clinical narrative: rash with both vaccines/rash now is on her neck, chest, and shoulder area; her neck is on fire; itchy; hot; This is a spontaneous report from a contactable physician (patient) A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Sep2021 14:00 (Batch/Lot Number: FC3182) as DOSE , SINGLE for covid-19 immunisation  .Age at vaccination 46:years.  Medical history included , Allergies: many medications.Age at vaccination :46 years old.The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 21Aug2021 (Time: Between 10:00-11:00AM;LOT: FC3180; vaccine site :  left arm ) and experienced rash. There were no concomitant medications.None prior vacciantions within 4 weeks.  The patient stated that she  experienced rash with both vaccines. She Got her second vaccination Saturday 11Sep2021. This morning, 13Sep2021, noticed the rash. Rash appeared after the same amount of time as it did with the first dose. Rash was reported as worsened but clarified her rash now is on her neck, chest, and shoulder area. All around her neck. Her neck was on fire.  Wants to scratch up into her scalp. Might be in her scalp, but not able to see it because of her hair. It is itchy and hot. It is on her back. Therapeutic measures were taken as a result of rash :She Has been taking Benadryl the entire time. The event didn't  result in ER or Physician office visit but she spoke with doctor and dermatologist. The outcome of the events was unknown.Additional information: Vaccination Facility Type: Pharmacy or Drug store;; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198306 same reporter/patient, different dose/event
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Wrong technique in product usage process
Clinical narrative: vaccine administered that was not reconstituted; vaccine administered that was not reconstituted; This is a spontaneous report from a contactable Nurse. This Nurse reported for 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FD0809; Expiration Date: 25Sep2021), dose 1 intramuscular, administered in Deltoid Left on 10Sep2021 15:30 (at the age of 57 years old) as dose 1, 0.3 ml single for covid-19 immunization. The Patient No medical history was reported. There were no concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Sep2021, the patient experienced vaccine administered that was not reconstituted. Incident report was filled out and it was reported to everyone at their office, including the nurse manager and provider.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: As per the information in the case provided, the causal association between the events  Wrong technique in product usage process and Poor quality vaccine administered and the suspect drug cannot be excluded.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased
Clinical narrative: Blood pressure was 178/90 mmHg; Heart rate went up/resting heart rate was 90 beats per minute; This is a spontaneous report from a contactable consumer (patient)  A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Sep2021 (Batch/Lot Number: FD8448) as DOSE 2, SINGLE for covid-19 immunisation  . Age at vaccination :56 years.The patient received the first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for covid-19 immunization (Anatomical Location: left shoulder). There were no concomitant medications and medical history. The clinical course was reported as follows: on 08 Sep2021 he received his second Covid 19 vaccine last Wednesday at around 9:00AM-9:30AM in the morning. His Covid 19 record card says FD8448. He works nights so after he received the vaccine he went home and slept because he had to work that night. He reports probably about 13 hours after he received the vaccine, around 10:00PM-11:00PM that night, he was sitting at his desk at work and his heart rate went up. His resting heart rate was 90 beats per minute. His blood pressure was 178/90 mmHg and it stayed that way for about 3 hours. He left work and was on his way home when he had to stop and call paramedics. The paramedics came to where he was stopped, and the paramedics checked him out. The paramedics put an ice bag on the back of his neck and he sat there for about 15 minutes. His symptoms calmed down enough that he felt safe enough to finish his drive home although his heartrate and blood pressure were still elevated. It probably lasted a total of about 5 hours and after that his heartrate and blood pressure returned to normal. While he was on his way home and if he was feeling bad when he passed by the emergency department close to his house, he would stop. But he didnt have to stop. He arrived home and he sat down and maybe within a couple hours everything was back to what he would call normal.Therapeutic measures were taken as a results of the events.The outcome of the events was recovered.No emergency room/phiscian office visit.Additional information : Vaccination Facility Type :Pharmacy/Drug Store;No prior vaccination within 4 weeks   Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: C-reactive protein, Dyspnoea, Hypersensitivity, Red blood cell sedimentation rate, Urticaria
Clinical narrative: I had a allergic reaction that I break out in hives; I had a allergic reaction that I break out in hives; had a little bit of difficulty in breathing; This is a spontaneous report from a contactable Nurse. A 31-years-old patient of an unspecified gender received bnt162b2 (BNT162B2) at age of 31 years via an unspecified route of administration, administered in Arm Left on 10Sep2021 (Batch/Lot Number: EW0164) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation and methylprednisolone acetate (METHYLPREDNISOLONE ACETATE), injection via an unspecified route of administration on 13Sep2021 (Batch/Lot number was not reported) as an unspecified dose for an unspecified indication. Medical history included fibromyalgia and rheumatoid arthritis. Concomitant medications included hydroxychloroquine (HYDROXYCHLOROQUINE) and sulfasalazine (SULFASALAZINE). On 13Sep2021 patient reported that "I had a allergic reaction that break out in hives and "I had a little bit of difficulty in breathing. All events with outcome of unknown. The patient reported that "bit of difficulty in breathing was not to the point that I have got I called the ambulance but I got 25mg Benadryl intramuscular and I got Solumedrol both as treatment. Patient underwent lab tests and procedures which included c-reactive protein: 0.4, red blood cell sedimentation rate: 11. Clinical course: patient received "COVID 19 shot on the 10th of September which is Friday. Today I went to my orthopedics and got methyl prednisolone injection in my 'wrist'. 5 min after leaving my orthopedic I had allergic reaction". I have a question the methyl Medrol the oral and the injection are they different or no?".; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 and methylprednisolone acetate cannot be excluded for the reported events urticaria, hypersensitivity and dyspnoea occurred in a plausible temporal relationship.  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.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Antibody test, Gynaecological examination, Haemorrhagic ovarian cyst
Clinical narrative: ovarian cyst/ Haemorrhagic Cyst; Irregular menstruation; Abnormal menstruation; Abdominal cramps and bloating; Abdominal cramps and bloating; This is a spontaneous report received from a contactable Physician. This is the second report of two reports. This report is related to the second vaccination dose. A 30-year-old patient of unknown gender received the second dose of bnt162b2 on 21May2021 at 16:00 (lot number: EW0170) Intramuscularly in left arm at single dose for COVID-19 immunization. Medical history included Acute appendicitis in 2011, Laparoscopic appendectomy in 2011. Concomitant medications were reported as none. Historical vaccine included the first dose of bnt162b2 on 30Apr2021 at 04:00 PM (Lot no: ER8731) (at the age of 30-years-old) Intramuscularly in right arm for COVID-19 immunization, experienced Abdominal cramps and bloating. Prior vaccination was reported as None. Family medical history was reported as None. Patient experienced Irregular menstruation (medically significant) on 02Jun2021 at 09:00 am, Abnormal menstruation on 02Jun2021, ovarian cyst/ Haemorrhagic Cyst (medically significant) on 30Jun2021, Abdominal cramps and bloating in 2021. The events were required physician office visit. Patient received treatment for events Irregular menstruation, ovarian cyst/ Haemorrhagic Cyst, Abnormal menstruation. Second vaccine dose administered on 21May2021. Abdominal cramps and bloating persisted. Abnormal menstruation on 02Jun2021. Patient was evaluated by OB/Gyn, FNP and Pelvic and transvaginal Ultrasound ordered 30Jun2021. Patient had ultrasounds at 3:21pm on 30Jun2021. Haemorrhagic Cyst noted on transvaginal ultrasound No history of ovarian cyst in patient prior. Lab data included: Antibody test to platelet factor IV on unknown date: Unknown results; Transvaginal ultrasound on 30Jun2021: Right away cyst, Haemorrhagic Cyst; Pelvic Ultrasound on 30Jun2021: Normal. The outcome of the events was not recovered. Physician considered the Pfizer product had a causal effect to the adverse events.; 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 Menstruation irregular, Haemorrhagic ovarian cyst and  Menstruation abnormal cannot be totally excluded.The impact of this report 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.
Sex: U
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular, Ultrasound scan vagina
Clinical narrative: ovarian cyst/ Haemorrhagic Cyst; Irregular menstruation; Abnormal menstruation; Abdominal cramps and bloating; Abdominal cramps and bloating; This is a spontaneous report received from a contactable Physician. This is the second report of two reports. This report is related to the second vaccination dose. A 30-year-old patient of unknown gender received the second dose of bnt162b2 on 21May2021 at 16:00 (lot number: EW0170) Intramuscularly in left arm at single dose for COVID-19 immunization. Medical history included Acute appendicitis in 2011, Laparoscopic appendectomy in 2011. Concomitant medications were reported as none. Historical vaccine included the first dose of bnt162b2 on 30Apr2021 at 04:00 PM (Lot no: ER8731) (at the age of 30-years-old) Intramuscularly in right arm for COVID-19 immunization, experienced Abdominal cramps and bloating. Prior vaccination was reported as None. Family medical history was reported as None. Patient experienced Irregular menstruation (medically significant) on 02Jun2021 at 09:00 am, Abnormal menstruation on 02Jun2021, ovarian cyst/ Haemorrhagic Cyst (medically significant) on 30Jun2021, Abdominal cramps and bloating in 2021. The events were required physician office visit. Patient received treatment for events Irregular menstruation, ovarian cyst/ Haemorrhagic Cyst, Abnormal menstruation. Second vaccine dose administered on 21May2021. Abdominal cramps and bloating persisted. Abnormal menstruation on 02Jun2021. Patient was evaluated by OB/Gyn, FNP and Pelvic and transvaginal Ultrasound ordered 30Jun2021. Patient had ultrasounds at 3:21pm on 30Jun2021. Haemorrhagic Cyst noted on transvaginal ultrasound No history of ovarian cyst in patient prior. Lab data included: Antibody test to platelet factor IV on unknown date: Unknown results; Transvaginal ultrasound on 30Jun2021: Right away cyst, Haemorrhagic Cyst; Pelvic Ultrasound on 30Jun2021: Normal. The outcome of the events was not recovered. Physician considered the Pfizer product had a causal effect to the adverse events.; 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 Menstruation irregular, Haemorrhagic ovarian cyst and  Menstruation abnormal cannot be totally excluded.The impact of this report 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inflammation, Pain, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19.; Tested positive for COVID-19.; Was treated for pain and inflammation.; Was treated for pain and inflammation.; This is a spontaneous report from a contactable consumer (Pfizer colleague). An adult male patient received bnt162b2 in Jun2021 (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was not reported whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine and the patient received any medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Admitted to ER approximately 6 weeks ago due to shortness of breath and fever. Lungs were determined to be clear. Was treated for pain and inflammation. Released approximately 12 hours later. Tested positive for COVID-19 in 2021. Patient received the treatment for the events including Ivermectin. The outcome of the events was recovered in 2021. The events did not result in death, hospitalization, disability, Congenital Anomaly. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.