chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac infection, Chest pain, Dyspnoea, Pneumonia
Clinical narrative: pneumonia; inflammation to the heart; Shortness of breath; chest pain; This is a spontaneous report from a contactable consumer (patient).   A 14-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0150, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 22May2021 08:00 at age of 14 years old as a single dose for covid-19 immunisation. Medical history included pericarditis with inflammation. The patient's concomitant medications were not reported.  The patient previously took vancomycin and experienced allergies. The patient experienced pneumonia, inflammation to the heart, shortness of breath, chest pain, all on 23May2021 07:00.  The outcome of the events was not recovered. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events resulted in emergency room/department or urgent care. The patient received treatment for the events included Antibiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Musculoskeletal stiffness, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Right biceps pain and weakness, tingling in right hand and digits #1, 2, 3 began about 3 to 4 hours after vaccination. Difficulty lifting arm above head due to pain, stiffness, weakness. Improvement in symptoms on Day 2 and more improvement Day 3. Soreness and some weakness when lifting right arm above head in day 4.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Servere chest pain, likely described from this article
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: 4:00 pm 6/7/21 left shoulder pain becoming noticeable 10:00 pm 6/7/21 body aches and fever, temp 98.3 F which is about 1.5 F above normal, 2 acetaminophen 500 mg, went to bed 11:00, fell asleep 11:50 pm 5:30 am 6/8/21, aches continue, temp 99.8 6:00 am 6/8/21, 2 ibuprofen 200 mg, file this report, try to sleep
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: Congestive heart failure; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 24Apr2021 10:00 at age of 61years old as a single dose for COVID-19 immunisation.  Medical history included congestive heart failure from Mar2013 to an unknown date, Chronic Kidney Disease Stage 2, cured Type 2 Diabetes from Dec2019 to an unknown date. Concomitant medication included losartan. The patient experienced congestive heart failure on 04May2021 12:00 with outcome of recovering. Therapeutic measures were taken as a result of congestive heart failure. The adverse event result in following: Emergency room/department or urgent care. Treatment for the adverse event included LASIK Intravenous (IV). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0168, expiration date not provided), 2nd dose via an unspecified route of administration, administered in Arm Left on 15May2021 09:30 at age of 61years old as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Body height, Eye irritation, Inflammation, Iridocyclitis
Clinical narrative: now inflammation that is causing blindness; eye irritation; inflammation; Open-Angle Glaucoma; Uveitis; Granulomatous Anterior Uveitis; Uveitic Ocular Hypertension; This is a spontaneous report from a contactable consumer (patient).   A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: er8735; Expiration Date: 31Jul2021), 1st dose via an unspecified route of administration, administered in Arm Left on 01May2021 at age of 36 years old as a single dose for COVID-19 immunisation. Medical history included celiac disease and gastroparesis. The patient's concomitant medications were not reported. The patient experienced open-angle glaucoma, uveitis, granulomatous anterior uveitis, uveitic ocular hypertension, all on 16May2021, now inflammation that is causing blindness, eye irritation, inflammation, all on an unspecified date. The patient underwent lab tests and procedures which included weight: 73.48 kg, height: 145cm, both on an unknown date. Therapeutic measures were taken as a result of all events. The outcome of the events was not recovered. Clinical course: consumer stated, "I was calling to report a possible side effect I do not see to do it online so I decided to call in." Consumer stated, "I had started to having a eye irritation that has turned into glaucoma that they are thinking had a now inflammation that is causing blindness." Consumer informed about Pfizer medical information department. Consumer stated, "Expiration July 31, 2021." Consumer stated, "Its started on Sunday ( Later confirmed May 16 2021)." Site of vaccination: consumer stated," Left arm." Other medication for medical conditions: consumer stated, "No , nothing Its all diet , its diet regulation." Lab Test: consumer  stated, "No, everything comes negative." Still experiencing the events:  consumer  stated, "Yes, its same." Outcome of events: consumer stated," Same." Treatment in response to events:  Consumer stated,  Valacyclovir, Cyclopentolate, Brimonidine, Acetazolamide, Prednisolone." There had no known allergies. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. The adverse events (open-angle glaucoma, uveitis, granulomatous anterior uveitis, uveitic ocular hypertension) resulted in following: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The treatment for the adverse events was included medications and eye drops. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hypertension, Open angle glaucoma, Uveitis, Weight
Clinical narrative: now inflammation that is causing blindness; eye irritation; inflammation; Open-Angle Glaucoma; Uveitis; Granulomatous Anterior Uveitis; Uveitic Ocular Hypertension; This is a spontaneous report from a contactable consumer (patient).   A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: er8735; Expiration Date: 31Jul2021), 1st dose via an unspecified route of administration, administered in Arm Left on 01May2021 at age of 36 years old as a single dose for COVID-19 immunisation. Medical history included celiac disease and gastroparesis. The patient's concomitant medications were not reported. The patient experienced open-angle glaucoma, uveitis, granulomatous anterior uveitis, uveitic ocular hypertension, all on 16May2021, now inflammation that is causing blindness, eye irritation, inflammation, all on an unspecified date. The patient underwent lab tests and procedures which included weight: 73.48 kg, height: 145cm, both on an unknown date. Therapeutic measures were taken as a result of all events. The outcome of the events was not recovered. Clinical course: consumer stated, "I was calling to report a possible side effect I do not see to do it online so I decided to call in." Consumer stated, "I had started to having a eye irritation that has turned into glaucoma that they are thinking had a now inflammation that is causing blindness." Consumer informed about Pfizer medical information department. Consumer stated, "Expiration July 31, 2021." Consumer stated, "Its started on Sunday ( Later confirmed May 16 2021)." Site of vaccination: consumer stated," Left arm." Other medication for medical conditions: consumer stated, "No , nothing Its all diet , its diet regulation." Lab Test: consumer  stated, "No, everything comes negative." Still experiencing the events:  consumer  stated, "Yes, its same." Outcome of events: consumer stated," Same." Treatment in response to events:  Consumer stated,  Valacyclovir, Cyclopentolate, Brimonidine, Acetazolamide, Prednisolone." There had no known allergies. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. The adverse events (open-angle glaucoma, uveitis, granulomatous anterior uveitis, uveitic ocular hypertension) resulted in following: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The treatment for the adverse events was included medications and eye drops. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bedridden, Breast mass, Chest pain, Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) intramuscularly on arm left on 17May2021 at 09:45 AM at age of 69-year-old at single dose for COVID-19 immunisation. Patient was not pregnant at time of vaccination and events onset. Medical history included arthritis, penicillin allergy and latex allergy. Concomitant medications included levomilnacipran hydrochloride (FETZIMA) received within 2 weeks of vaccination. Patient experienced large painful lumps in breasts, pain in ribcage and across back. Patient was bedridden and this was the 6th day (23May2021). Onset date of events was 17May2021 at time of 02:15 PM (reported as 02:15). Events were reported as serious as disability. Outcome of the events was recovered with sequel. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Lymphadenopathy, Neuropathy peripheral, Rash
Clinical narrative: shingles; Rash on right arm started to appear; Swollen lymph node above left collar bone/ swollen lymph nodes in right groin and right armpit; neuropathy; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received second dose of BNT162B2 (Lot Number: ER8736), via an unspecified route of administration, administered in left arm on 18May2021 at 09:30 AM at age of 30-year-old as single dose for covid-19 immunisation. Medical history included anxiety and depression, Cephalosporins allergy. The patient previously received first dose of BNT162B2 (Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 27Apr2021 at 09:30 AM at age of 30-year-old as single dose for covid-19 immunisation. Concomitant medication included welbutrin 300mg long acting. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was diagnosed with neuropathy on 19May2021 at 7:00 AM (1 day after the vaccine), swollen lymph node above left collar bone on 20May2021 (2 days after the vaccine), swollen lymph nodes in right groin and right armpit on 21May2021 (day 3 after the vaccine), rash on right arm started to appear on 22May2021 (4 days after the vaccine), shingles on 23May2021 (5 days after vaccine). The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Valacyclovir 1gm tabs twice daily (2x daily). The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Palpitations, Pericarditis, Polymerase chain reaction
Clinical narrative: pericarditis; shortness of breath; heart palpitations; chest tightness; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included protein (whey protein isolate); multivitamin [vitamins nos]; vitamin d3. The patient experienced pericarditis, shortness of breath, heart palpitations, chest tightness on 16Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received treatment for the adverse event included indomethacin and colchicine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR) with Nasal Swab was negative on 17Apr2021; negative on 21Apr2021. The outcome of the event pericarditis was unknown, the outcome of the other events was not resolved.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable other hcp (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 11Jan2021 10:45 (Batch/Lot number was not reported) at the age of 40 years old, as 2ND DOSE, SINGLE DOSE, and dose 1 via an unspecified route of administration, administered in left arm on 23Dec2020 10:30 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included mild hypertension and exposure to an unvaccinated person who became COVID positive. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 01May2021 07:00 AM, the patient had a breakthrough infection and was found to be COVID positive on 03May2021. It was a mild to moderate infection. The patient was exposed to an unvaccinated person who became COVID positive. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatments received which included Tylenol, fluticasone propionate, omeprazole. The patient was recovering from the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent Nasal swab/RT-PCR test for COVID-19 on 03May2021 and tested positive. The events were reported as non-serious by the reporter.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose normal, Blood pressure measurement, Blood test normal, Cerebrovascular accident
Clinical narrative: stroke like symptoms; joint pains; can not walk or perform my routine, hard to work; heart palpitations; can not walk or perform my routine, hard to work; This is a spontaneous report from a contactable consumer (patient). The 36-years-old male patient received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced stroke like symptoms, joint pain, can not walk or perform my routine, hard to work, heart palpitations on an unspecified date. Reported as: The patient had no significant medical conditions. The patient got the first dose of COVID vaccine three weeks ago and been to multiple doctors and emergency room in three weeks. "I had stroke like symptoms but all CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans returned normal, all my blood work, blood sugar levels, blood pressure, thyroid levels are normal. I have joint pains so severe that I can not walk or perform my routine, hard to work( I work desk job). On top of it, I have heart palpitations for the last two days and no one knows why". The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Gait inability, Loss of personal independence in daily activities, Magnetic resonance imaging, Palpitations
Clinical narrative: stroke like symptoms; joint pains; can not walk or perform my routine, hard to work; heart palpitations; can not walk or perform my routine, hard to work; This is a spontaneous report from a contactable consumer (patient). The 36-years-old male patient received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced stroke like symptoms, joint pain, can not walk or perform my routine, hard to work, heart palpitations on an unspecified date. Reported as: The patient had no significant medical conditions. The patient got the first dose of COVID vaccine three weeks ago and been to multiple doctors and emergency room in three weeks. "I had stroke like symptoms but all CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans returned normal, all my blood work, blood sugar levels, blood pressure, thyroid levels are normal. I have joint pains so severe that I can not walk or perform my routine, hard to work( I work desk job). On top of it, I have heart palpitations for the last two days and no one knows why". The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Thyroid function test
Clinical narrative: stroke like symptoms; joint pains; can not walk or perform my routine, hard to work; heart palpitations; can not walk or perform my routine, hard to work; This is a spontaneous report from a contactable consumer (patient). The 36-years-old male patient received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced stroke like symptoms, joint pain, can not walk or perform my routine, hard to work, heart palpitations on an unspecified date. Reported as: The patient had no significant medical conditions. The patient got the first dose of COVID vaccine three weeks ago and been to multiple doctors and emergency room in three weeks. "I had stroke like symptoms but all CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans returned normal, all my blood work, blood sugar levels, blood pressure, thyroid levels are normal. I have joint pains so severe that I can not walk or perform my routine, hard to work( I work desk job). On top of it, I have heart palpitations for the last two days and no one knows why". The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Dyspnoea, Fatigue
Clinical narrative: 12 days after first dose vomited clotted blood; 12 days after first dose vomited clotted blood; chest tightness; extreme fatigue to the point of barely being able to walk continued for several weeks.; extreme fatigue to the point of barely being able to walk continued for several weeks.; bleeding; elevated HR; BP; elevated HR; BP; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6202) via an unspecified route of administration, administered on the left arm on 01Mar2021 as 1st dose, single for COVID-19 immunization. Medical history included Echo from Nov2020, exposure to A. flavus in 2014 with development of fungal ball in sphenoid cavity causing brain injury and all body damage, Autonomic disorder developed tachycardia. Concomitant medications were not reported. It was reported that 12 days after first dose on 13Mar2021, patient vomited clotted blood; hospitalized. The patient was hospitalized from 13Mar2021 to 15Mar2021. Cleared and discharged after a day unknown cause of bleeding on 16Mar2021. Elevated HR; BP; difficulty breathing, chest tightness and extreme fatigue to the point of barely being able to walk continued for several weeks. Events were considered serious, disability. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. No treatment was received. Covid test post vaccination: Nasal Swab on 22Mar2021 and 10Apr2021 Negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event vomited clotted blood was recovered on 15Mar2021 while not recovered for the other events.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Haematemesis, Haemorrhage, Heart rate, Heart rate increased
Clinical narrative: 12 days after first dose vomited clotted blood; 12 days after first dose vomited clotted blood; chest tightness; extreme fatigue to the point of barely being able to walk continued for several weeks.; extreme fatigue to the point of barely being able to walk continued for several weeks.; bleeding; elevated HR; BP; elevated HR; BP; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6202) via an unspecified route of administration, administered on the left arm on 01Mar2021 as 1st dose, single for COVID-19 immunization. Medical history included Echo from Nov2020, exposure to A. flavus in 2014 with development of fungal ball in sphenoid cavity causing brain injury and all body damage, Autonomic disorder developed tachycardia. Concomitant medications were not reported. It was reported that 12 days after first dose on 13Mar2021, patient vomited clotted blood; hospitalized. The patient was hospitalized from 13Mar2021 to 15Mar2021. Cleared and discharged after a day unknown cause of bleeding on 16Mar2021. Elevated HR; BP; difficulty breathing, chest tightness and extreme fatigue to the point of barely being able to walk continued for several weeks. Events were considered serious, disability. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. No treatment was received. Covid test post vaccination: Nasal Swab on 22Mar2021 and 10Apr2021 Negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event vomited clotted blood was recovered on 15Mar2021 while not recovered for the other events.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: 12 days after first dose vomited clotted blood; 12 days after first dose vomited clotted blood; chest tightness; extreme fatigue to the point of barely being able to walk continued for several weeks.; extreme fatigue to the point of barely being able to walk continued for several weeks.; bleeding; elevated HR; BP; elevated HR; BP; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6202) via an unspecified route of administration, administered on the left arm on 01Mar2021 as 1st dose, single for COVID-19 immunization. Medical history included Echo from Nov2020, exposure to A. flavus in 2014 with development of fungal ball in sphenoid cavity causing brain injury and all body damage, Autonomic disorder developed tachycardia. Concomitant medications were not reported. It was reported that 12 days after first dose on 13Mar2021, patient vomited clotted blood; hospitalized. The patient was hospitalized from 13Mar2021 to 15Mar2021. Cleared and discharged after a day unknown cause of bleeding on 16Mar2021. Elevated HR; BP; difficulty breathing, chest tightness and extreme fatigue to the point of barely being able to walk continued for several weeks. Events were considered serious, disability. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. No treatment was received. Covid test post vaccination: Nasal Swab on 22Mar2021 and 10Apr2021 Negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event vomited clotted blood was recovered on 15Mar2021 while not recovered for the other events.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dysarthria, SARS-CoV-2 test
Clinical narrative: COVID test result positive; Slurred speech, difficulty putting thoughts to words in complete sentences; Slurred speech, difficulty putting thoughts to words in complete sentences; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 14May2021 08:00 (Batch/Lot Number: EW0177.CCC-MN, as reported) (at the age of 15 years old) as 1st dose, single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication included ibuprofen. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered at Clinic. The patient experienced slurred speech, difficulty putting thoughts to words in complete sentences on 14May2021 08:30 and COVID test result positive on 18May2021. There was no treatment for the events. No COVID prior vaccination. The patient underwent lab tests and procedures which included PCR Saliva (COVID-19 test): positive  on 18May2021. The outcome of the events was recovered on unspecified date.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Muscle spasms, Vaginal haemorrhage
Clinical narrative: bleeding; Vaginal spotting and some discomfort (cramping); Vaginal spotting and some discomfort (cramping); Vaginal spotting and some discomfort (cramping); This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient (not pregnant) received bnt162b2, dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization at the age of 26 years old. The patient received bnt162b2, dose 2 via an unspecified route of administration on 19Apr2021 13:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization The patient medical history was not reported. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced bleeding, vaginal spotting and some discomfort (cramping) on 05Apr2021. Reported as: Vaginal spotting and some discomfort (cramping). Its has been occurring since the fist dose in March. I am on the birth control Yaz but I am regular with taking it and it has been the same birth control for over a year. I have not had regular spotting before and I went to an OBGYN on 5/12 and there were no abnormalities that would indicate another cause of the bleeding. It's not serious but I'm reporting in the hope that your studies begin including effects on things like menstrual cycle because it sounds like there are effects like this happening.The adverse event result Doctor or other healthcare professional office/clinic visit. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Computerised tomogram, Herpes zoster, Hypoaesthesia
Clinical narrative: Severe pain in right lower back; Severe pain in right lower back; traveled to lower right abdomen; It left a numb feeling behind; The caller thinks he has a rare case of shingles happening; Slight swelling on right side; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 48-year-old, via an unspecified route of administration, administered in left deltoid on 23Apr2021 (Lot Number: EW0171; Expiration Date: 31Aug2021) as 1st dose, single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia from 2021 and ongoing (states he was diagnosed about 2 months ago) and had shingles once already when he was 20 years old. The patient's concomitant medications were not reported. The patient stated that he had the first dose of the vaccine on 23Apr2021. The patient experienced severe pain in his right lower back on 23Apr2021. He spent 24Apr2021, 25Apr2021, and 26Apr2021 at the hospital in the Emergency Room getting treated for severe pain in his right lower back. He states they ran all kinds of tests, but they could not figure out what was going on.  States he was not admitted to the hospital during that time; he was treated for severe pain in his right lower back in the Emergency Room. The patient mentions that his wife also had the vaccine and she had a sore arm and some body soreness, but she wasn't sick or anything like that. He states he was still recovering from severe pain in his right lower back. The pain migrated from his back around to the lower right side of his abdomen on Apr2021. States that it left a numb feeling behind on Apr2021. The patient stated that after reading and after seeing 5 doctors; the patient told his oncologist that he thinks he has a rare case of shingles happening on Apr2021. He thinks it was the very rare kind where you don't have a rash appear. He had shingles once already when he was 20 years old. This time he thinks that was what it was again with no rash, just pain and discomfort. The severe pain in his right lower back was much better than it was. Says his skin looks normal. There was some slight swelling on his right side on Apr2021. The patient states that when it was time for his second dose of the vaccine, he hadn't recovered from the first dose. He did not go get his second dose; states his doctor agreed with that decision. Severe pain in right lower back, traveled to lower right abdomen resulted in emergency room and physician office visit. The patient underwent lab tests and procedures on Apr2021 which included CT scan (they were checking his lymphatic system), MRI and Ultrasound were done at the Emergency Room. The patient stated they found nothing on these tests. The outcome of the event low back pain was recovering and for the rest of the events was unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Swelling, Ultrasound scan
Clinical narrative: Severe pain in right lower back; Severe pain in right lower back; traveled to lower right abdomen; It left a numb feeling behind; The caller thinks he has a rare case of shingles happening; Slight swelling on right side; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 48-year-old, via an unspecified route of administration, administered in left deltoid on 23Apr2021 (Lot Number: EW0171; Expiration Date: 31Aug2021) as 1st dose, single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia from 2021 and ongoing (states he was diagnosed about 2 months ago) and had shingles once already when he was 20 years old. The patient's concomitant medications were not reported. The patient stated that he had the first dose of the vaccine on 23Apr2021. The patient experienced severe pain in his right lower back on 23Apr2021. He spent 24Apr2021, 25Apr2021, and 26Apr2021 at the hospital in the Emergency Room getting treated for severe pain in his right lower back. He states they ran all kinds of tests, but they could not figure out what was going on.  States he was not admitted to the hospital during that time; he was treated for severe pain in his right lower back in the Emergency Room. The patient mentions that his wife also had the vaccine and she had a sore arm and some body soreness, but she wasn't sick or anything like that. He states he was still recovering from severe pain in his right lower back. The pain migrated from his back around to the lower right side of his abdomen on Apr2021. States that it left a numb feeling behind on Apr2021. The patient stated that after reading and after seeing 5 doctors; the patient told his oncologist that he thinks he has a rare case of shingles happening on Apr2021. He thinks it was the very rare kind where you don't have a rash appear. He had shingles once already when he was 20 years old. This time he thinks that was what it was again with no rash, just pain and discomfort. The severe pain in his right lower back was much better than it was. Says his skin looks normal. There was some slight swelling on his right side on Apr2021. The patient states that when it was time for his second dose of the vaccine, he hadn't recovered from the first dose. He did not go get his second dose; states his doctor agreed with that decision. Severe pain in right lower back, traveled to lower right abdomen resulted in emergency room and physician office visit. The patient underwent lab tests and procedures on Apr2021 which included CT scan (they were checking his lymphatic system), MRI and Ultrasound were done at the Emergency Room. The patient stated they found nothing on these tests. The outcome of the event low back pain was recovering and for the rest of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID and symptomatic; diagnosed with COVID and symptomatic; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient diagnosed with COVID and symptomatic/got COVID-19 after first vaccination but before second one in recent weeks.  Event took place after use of product. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: I have cancer; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient took first shot Pfizer at Hospital on 17Apr2021. The patient didn't get the second shot because the patient was in the hospital and the patient had cancer so the patient missed the appointment. The patient want to take the 2nd shot on Sunday. When probed for permission to probe, Consumer refused and said that he/she really didn't feel better. He/she just had a question. The outcome of the event was not recovered.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer Colleague. A patient of unspecified age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient diagnosed with COVID and symptomatic/got COVID-19 after first vaccination but before second one in recent weeks. Event took place after use of product. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID-19 after first vaccination but before the second one; got COVID-19 after first vaccination but before the second one; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient got COVID-19 after first vaccination but before the second one. Event outcome was unknown.    Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID and symptomatic; diagnosed with COVID and symptomatic; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender (retired employee) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on an unspecified date, dose 2 via an unspecified route of administration on an unspecified date, both at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was fully vaccinated, diagnosed with COVID and symptomatic. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: had a period for approx. 10 days after both vaccines. She was post menopausal; This is a spontaneous report from a contactable consumer (reported for herself). A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:30 (at the age of 57 years old) (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 11:15 (at the age of 57 years old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Hypothyroidism, post menopausal. No known allergies. Concomitant medication received within 2 weeks of vaccination included levothyroxine sodium (TIROSINT). Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a period for approx. 10 days after both vaccines. She was post menopausal. The event started in Mar2021. No treatment for the event. The reporter considered as the event was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: has slight cold; This is a spontaneous report from a Pfizer sponsored program(CEP: 159558). A contactable consumer (patient herself) reported that a Female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown, NDC number: Unknown, UPC number: Unknown, Expiry Date: Unknown), via an unspecified route of administration on 24Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It is reported that, she will be having 2nd dose tomorrow morning; On an Unspecified dat, patient had slight cold  and she wanted to get opinion if she can go ahead and take 2nd dose of vaccine tomorrow (on unspecified date)". She also stated, Yes she will like an opinion but that day.Patient asked that, Will they be open today like then the reason she asked she was supposed to get it tomorrow (unspecified date) morning 07:40am." Reporter seriousness for the event was unspecified. Outcome of the event was unknown.  Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Eye pain, Headache, Lung disorder, Nasopharyngitis
Clinical narrative: Caller states he doesn't want to make other people sick and right now he is in quarantine since he does not know if he has COVID-19 or not.; right now he is in quarantine since he does not know if he has COVID-19 or not; fever; headache; cold; his body hurts; lungs hurt; eyes hurt; sore throat; Caller states before with the first and second shot he got no symptoms except a sore arm; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 27Apr2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The vaccination facility explained he may have some symptoms over the next couple of days be did not have any. The patient began having symptoms two days ago which was three weeks later from his second dose. The patient would like to know since he has received both doses and experiencing side effects that include fever, headache and a cold can he take medication for it or does he need to go to a doctor. His body hurts, lungs hurt, eyes hurt and he has a sore throat too. Yesterday he brought alka-seltzer plus cold and flu and it didn't help as he was still sore today. Today he has not had a fever but he had a fever yesterday and the day before. Before with the first and second shot he got no symptoms except a sore arm. The patient would like to know if he can go outside. He doesn't want to make other people sick and right now he was in quarantine since he does not know if he has COVID-19 or not. He was not going to work right now either. The patient received treatment for events. Outcome of the event was unknown.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Pyrexia, Suspected COVID-19
Clinical narrative: Caller states he doesn't want to make other people sick and right now he is in quarantine since he does not know if he has COVID-19 or not.; right now he is in quarantine since he does not know if he has COVID-19 or not; fever; headache; cold; his body hurts; lungs hurt; eyes hurt; sore throat; Caller states before with the first and second shot he got no symptoms except a sore arm; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 27Apr2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The vaccination facility explained he may have some symptoms over the next couple of days be did not have any. The patient began having symptoms two days ago which was three weeks later from his second dose. The patient would like to know since he has received both doses and experiencing side effects that include fever, headache and a cold can he take medication for it or does he need to go to a doctor. His body hurts, lungs hurt, eyes hurt and he has a sore throat too. Yesterday he brought alka-seltzer plus cold and flu and it didn't help as he was still sore today. Today he has not had a fever but he had a fever yesterday and the day before. Before with the first and second shot he got no symptoms except a sore arm. The patient would like to know if he can go outside. He doesn't want to make other people sick and right now he was in quarantine since he does not know if he has COVID-19 or not. He was not going to work right now either. The patient received treatment for events. Outcome of the event was unknown.  Follow-up attempts completed. No further information is expected.