chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nephrolithiasis, Pain in extremity, Rhinorrhoea, Sneezing
Clinical narrative: sneezed; runny nose; arm began to feel sore; couldn't sleep; kidney stones; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 10Mar2021 at 13:00 as a single dose for COVID-19 immunization.  Medical history included family history of lymphoma and back problems/pain from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that on the evening of the day of the vaccination, 10Mar2021, the patient's arm began to feel sore and she couldn't sleep due to the discomfort. The patient took ibuprofen to help the pain and it lasted for about three days. She also reported that on 14Mar2021, the patient had a very runny nose on the 4th day and says she sneezed 80-100 times. The patient said her friend took the vaccine and reported sneezing, as well. The patient took Tylenol before the vaccine. The patient added that she has back problems/pain and regularly takes 1-2 ibuprofen a day and was told by someone that she should not take ibuprofen because it could interfere with the vaccine. The patient wanted to know if this was true. The patient also reported that she has kidney stones on Mar2021 and was "screaming and hollering yesterday" because of the pain. She takes hydrangea root to break down the kidney stones and ibuprofen. She added that they've had 5 or 6 people around here lost and 2 cousins lost (died) to lymphoma and multiple people in her family have died from lymphoma. She was concerned the vaccine could cause lymphoma. The outcome of the event arm began to feel sore and couldn't sleep was recovered on Mar2021. The outcome of the other events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Pneumonia
Clinical narrative: pneumonia; bad asthma; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included allergy to insect bite from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported that her doctor never told her she was getting a steroid shot 4 days after the first dose. Held the 2nd dose for 2 weeks and the next appointment is on 05Apr2021. The patient have bad asthma and had pneumonia from it. The patient was very fit and healthy. Also got 2 flu shots in the past. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Pain in extremity, Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: developed blood clots in my left leg that began swelling some on 12Mar2021 and by Monday 15Mar2021 it was huge and 16Mar2021 big and hurting; developed blood clots in my left leg that began swelling some on 12Mar2021 and by Monday 15Mar2021 it was huge and 16Mar2021 big and hurting; developed blood clots in my left leg that began swelling some on 12Mar2021 and by Monday 15Mar2021 it was huge and 16Mar2021 big and hurting; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 02Mar2021 16:00 (at 71-year-old) as single dose for COVID-19 immunization. Medical history included Arthritis in knee. High blood pressure. Patient had no covid prior vaccination and no covid tested post vaccination. Patient has no known allergies. Concomitant medication included hydrochlorothiazide. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient developed blood clots in my left leg that began swelling some on 12Mar2021 17:00 and by Monday 15Mar2021 it was huge and 16Mar2021 big and hurting. So he went to urgent care and they sent him to hospital ER. The patient was hospitalized for 3 days. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Events treatment included Ultra sound, CT scan, heparin blood thinner. The outcome of the events was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid ptosis, Fatigue, Gait disturbance, Headache, Hemiplegia
Clinical narrative: Left side of neck, site of injection, elbow, joints and muscles down left side; Left side headache continuing to spread; Left jaw, cheek, nasal area swelling; left eye sagging/ occasional eye droop; Tired; general aches mostly on left side; wobbly; hives; skin itching; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534 and expiration date not provided) via an unspecified route of administration, administered in left arm on 15Mar2021 15:45 as a single dose for COVID-19 immunisation. Medical history included hypertension, chronic dry eye, Bells Palsy, arthritis, allergies to penicillin, injected iodine and food sensitivities. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan, multivitamin and ciclosporin (CEQUA). On 15Mar2021 15: 45, the patient experienced left side headache continuing to spread. Left jaw, cheek, nasal area swelling and left eye sagging (previous site of Bells Palsy attack)-Left side of neck, site of injection, elbow, joints and muscles down left side. She was tired and progressed to general aches mostly on left side and was somewhat "wobbly" on 15Mar2021 15:45. She later had hives and skin itching on an unspecified date in Mar2021 which lasted a couple of days. Tiredness continues and swelling in face and occasional eye droop at 4 days out. No treatment was given in response to the events. The outcome of the event fatigue was not recovered while the outcome of the rest of the events was recovered on an unspecified date in Mar2021. The patient has not been tested for COVID-19 post vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Swelling face, Urticaria
Clinical narrative: Left side of neck, site of injection, elbow, joints and muscles down left side; Left side headache continuing to spread; Left jaw, cheek, nasal area swelling; left eye sagging/ occasional eye droop; Tired; general aches mostly on left side; wobbly; hives; skin itching; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534 and expiration date not provided) via an unspecified route of administration, administered in left arm on 15Mar2021 15:45 as a single dose for COVID-19 immunisation. Medical history included hypertension, chronic dry eye, Bells Palsy, arthritis, allergies to penicillin, injected iodine and food sensitivities. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan, multivitamin and ciclosporin (CEQUA). On 15Mar2021 15: 45, the patient experienced left side headache continuing to spread. Left jaw, cheek, nasal area swelling and left eye sagging (previous site of Bells Palsy attack)-Left side of neck, site of injection, elbow, joints and muscles down left side. She was tired and progressed to general aches mostly on left side and was somewhat "wobbly" on 15Mar2021 15:45. She later had hives and skin itching on an unspecified date in Mar2021 which lasted a couple of days. Tiredness continues and swelling in face and occasional eye droop at 4 days out. No treatment was given in response to the events. The outcome of the event fatigue was not recovered while the outcome of the rest of the events was recovered on an unspecified date in Mar2021. The patient has not been tested for COVID-19 post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pneumonia, Vomiting
Clinical narrative: pneumonia; very ill; vomitted; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (reported as 60, unit unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got very ill, vomitted  and ended up with pneumonia after getting the vaccine. The outcome of the events was unknown.  Information about lot/batch number is requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Cough, Delirium, Dyspnoea, Vomiting
Clinical narrative: delirious; could not even form a thought; Dry cough; difficulty breathing; vomiting; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 79-year-old, administered in Arm Left on 23Feb2021 13:30 (Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included hypertension, glaucoma, and COVID-19. The patient had no known allergies. The patient was not pregnant. Concomitant medication included amlodipine taken for an unspecified indication, start and stop date were not reported; latanoprost taken for an unspecified indication, start and stop date were not reported. The patient experienced delirious, could not even form a thought, dry cough, difficulty breathing, vomiting on 24Feb2021. Adverse event: February 24; All side effects listed by CDC except vomiting, also had dry cough, difficulty breathing and delirious (could not even form a thought). No treatment received for the events. The outcome of the events was recovering. The event delirious was considered as serious (medically significant).   No other vaccine in four weeks. The patient was diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Arachnoid cyst, Blood pressure increased, Blood pressure measurement, Computerised tomogram, Dizziness
Clinical narrative: arachnoid cyst on brain; blood pressure shot up to 163/100.; dizziness; Tingling in forehead, back of head; numbness on right side of face; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 18Mar2021 09:00 AM (Batch/Lot Number: EN6208), at the age of 65-years at vaccination, as (SINGLE DOSE) for COVID -19 immunisation.  Medical history included Hashimoto's disease, high blood pressure, Hailey-Hailey, Known allergies: sulfa and dyes. The patient is not pregnant at the time of the report. The patient does not have COVID prior vaccination. Concomitant medications included lisinopril taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; calcium, ergocalciferol (CALCIUM +D) taken for an unspecified indication, start and stop date were not reported. On 18Mar2021 09:15 AM, the patient had dizziness, tingling in forehead, back of head, numbness on right side of face. The patient notified the staff. They suggested she wait an additional 5 minutes and take Benadryl when I got home. The patient took the Benadryl and slept all day and night. The next morning, 19Mar2021, the patient thought she was improving but by 12(noon), the numbness, tingling of face and head was back. Her blood pressure shot up to 163/100. She went to urgent care and they gave her Clonidine to bring blood pressure down. CT scan done and showed that the patient have arachnoid cyst on brain. The patient will be scheduled for MRI, MRA, and carotid artery ultrasound. She was given scripts; Clonidine and hydrochlorothiazide. The events arachnoid cyst on brain  and blood pressure shot up was assessed as serious, event caused hospitalization. The events involve emergency room visit. The outcome of the events was not recovered. Treatment was given for the events. The patient was not tested for COVID post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: arachnoid cyst on brain; blood pressure shot up to 163/100.; dizziness; Tingling in forehead, back of head; numbness on right side of face; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 18Mar2021 09:00 AM (Batch/Lot Number: EN6208), at the age of 65-years at vaccination, as (SINGLE DOSE) for COVID -19 immunisation.  Medical history included Hashimoto's disease, high blood pressure, Hailey-Hailey, Known allergies: sulfa and dyes. The patient is not pregnant at the time of the report. The patient does not have COVID prior vaccination. Concomitant medications included lisinopril taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; calcium, ergocalciferol (CALCIUM +D) taken for an unspecified indication, start and stop date were not reported. On 18Mar2021 09:15 AM, the patient had dizziness, tingling in forehead, back of head, numbness on right side of face. The patient notified the staff. They suggested she wait an additional 5 minutes and take Benadryl when I got home. The patient took the Benadryl and slept all day and night. The next morning, 19Mar2021, the patient thought she was improving but by 12(noon), the numbness, tingling of face and head was back. Her blood pressure shot up to 163/100. She went to urgent care and they gave her Clonidine to bring blood pressure down. CT scan done and showed that the patient have arachnoid cyst on brain. The patient will be scheduled for MRI, MRA, and carotid artery ultrasound. She was given scripts; Clonidine and hydrochlorothiazide. The events arachnoid cyst on brain  and blood pressure shot up was assessed as serious, event caused hospitalization. The events involve emergency room visit. The outcome of the events was not recovered. Treatment was given for the events. The patient was not tested for COVID post vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Pruritus, Skin tightness, Throat tightness
Clinical narrative: However at 2pm symptoms came back as before along with chest tightness and hives.; However at 2pm symptoms came back as before along with chest tightness and hives.; after 5 mins felt tightness in my throat; felt skin tightness; followed by itchy face, eyes and stomach; developed a cough; This is a spontaneous report from a contactable consumer.     A 30-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 11:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation.  Medical history included arthritis reactive from Aug2020 , thyroid cancer from Aug2020. Concomitant medications included lansoprazole (LANSOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; etodolac (ETODOLAC) taken for an unspecified indication, start and stop date were not reported; celecoxib (CELECOXIB) taken for an unspecified indication, start and stop date were not reported.  The patient  after 5 mins felt tightness in her throat, felt skin tightness,  followed by itchy face, eyes and stomach, developed a cough  on 19Mar2021 with outcome of recovering , however at 2pm symptoms came back as before along with chest tightness and hives on 19Mar2021 14:00 with outcome of recovering.  All the reported events were considered serious because Impotant Medical Events.  Course of the event. Adverse event: after 5 mins felt tightness in the throat, then felt skin tightness, followed by itchy face, eyes and stomach, and developed a cough. At 1200 the patient  was given 25mg of Benadryl, and then another dose at 12:30. This improved symptoms and the patient  was starting to consider going home. However at 2pm symptoms came back as before along with chest tightness and hives. she was given another 25mg of Beandryl and an ambulance was called. In the hospital they gave  epinephrine, famotidine and methylprednisolone, which helped almost immediately. After a few hours she was discharged home.  Follow up information has been requested. Lot number already obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: However at 2pm symptoms came back as before along with chest tightness and hives.; However at 2pm symptoms came back as before along with chest tightness and hives.; after 5 mins felt tightness in my throat; felt skin tightness; followed by itchy face, eyes and stomach; developed a cough; This is a spontaneous report from a contactable consumer.     A 30-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 11:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation.  Medical history included arthritis reactive from Aug2020 , thyroid cancer from Aug2020. Concomitant medications included lansoprazole (LANSOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; etodolac (ETODOLAC) taken for an unspecified indication, start and stop date were not reported; celecoxib (CELECOXIB) taken for an unspecified indication, start and stop date were not reported.  The patient  after 5 mins felt tightness in her throat, felt skin tightness,  followed by itchy face, eyes and stomach, developed a cough  on 19Mar2021 with outcome of recovering , however at 2pm symptoms came back as before along with chest tightness and hives on 19Mar2021 14:00 with outcome of recovering.  All the reported events were considered serious because Impotant Medical Events.  Course of the event. Adverse event: after 5 mins felt tightness in the throat, then felt skin tightness, followed by itchy face, eyes and stomach, and developed a cough. At 1200 the patient  was given 25mg of Benadryl, and then another dose at 12:30. This improved symptoms and the patient  was starting to consider going home. However at 2pm symptoms came back as before along with chest tightness and hives. she was given another 25mg of Beandryl and an ambulance was called. In the hospital they gave  epinephrine, famotidine and methylprednisolone, which helped almost immediately. After a few hours she was discharged home.  Follow up information has been requested. Lot number already obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:00 (Batch/Lot number was not reported) as single dose at the age of 69 years old, for covid-19 immunisation. Medical history included allergy to penicillin and quinolones, and patient cannot eat cheese and other ages food (not an allergy, a sensitity). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient takes unspecified concomitant medications. The patient previously took ciprofloxacin and codeine and experienced allergy with these medications. The patient previously received first dose of bnt162b2 on 11Feb2021 at the age of 59 years old for COVID-19 immunization (product: COVID 19, brand: Pfizer, lot number: EI3302, administration time: 01:00 PM, vaccine location: right arm). The patient did not receive any other vaccine four weeks prior to COVID vaccination. The patient experienced shingles on 12Mar2021 19:00. Therapeutic measures were taken as a result of shingles as Veltrex and triamcinolone were given as treatment to the patient. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was hospitalized due to the event on an unspecified date. The patient has not recovered from the event.   Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Severe bilateral tinnitus; Hearing loss; This is a spontaneous report from a contactable nurse reporting for self. A 38-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm  on 19Jan2021 (at the age of 38-years old) (Batch/Lot Number: EL1293) as a single dose for COVID-19 immunization. The patient had not received any other vaccines in the 4 weeks prior.  Medical history included postural orthostatic tachycardia syndrome (POTS) from an unknown date. The patient had not experienced COVID prior to vaccination. The patient's concomitant medications were not reported.  The patient previously received first dose of BNT 162b2 on 29Dec2020 at 12:00 PM, in left arm for COVID-19 immunization; and previously received CECLOR and experienced allergy.  The patient developed severe bilateral tinnitus and hearing loss on 04Feb2021 at 2:00am, 2 weeks after vaccination with 2nd dose. The event resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit, and Disability or permanent damage. As treatment for the events, the nurse reported "multiple visits to doctors and medications hearing." The outcome of the events severe bilateral tinnitus and hearing loss were not recovered. The patient wasnot COVID-tested post vaccination.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of tinnitus and hearing loss due to temporal relationship.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Audiogram abnormal, Deafness, Tinnitus
Clinical narrative: Severe bilateral tinnitus; Hearing loss; This is a spontaneous report from a contactable nurse reporting for self. A 38-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm  on 19Jan2021 (at the age of 38-years old) (Batch/Lot Number: EL1293) as a single dose for COVID-19 immunization. The patient had not received any other vaccines in the 4 weeks prior.  Medical history included postural orthostatic tachycardia syndrome (POTS) from an unknown date. The patient had not experienced COVID prior to vaccination. The patient's concomitant medications were not reported.  The patient previously received first dose of BNT 162b2 on 29Dec2020 at 12:00 PM, in left arm for COVID-19 immunization; and previously received CECLOR and experienced allergy.  The patient developed severe bilateral tinnitus and hearing loss on 04Feb2021 at 2:00am, 2 weeks after vaccination with 2nd dose. The event resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit, and Disability or permanent damage. As treatment for the events, the nurse reported "multiple visits to doctors and medications hearing." The outcome of the events severe bilateral tinnitus and hearing loss were not recovered. The patient wasnot COVID-tested post vaccination.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of tinnitus and hearing loss due to temporal relationship.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Breast pain, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: Severe pain under right breast around into upper right back.  Was hospitalized 12Mar2020 for two days.  Pain is still very intense; Severe pain under right breast around into upper right back.  Was hospitalized 12Mar2020 for two days.  Pain is still very intense.; This is a spontaneous report from a contactable other health professional (HCP). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in right arm on 11Feb2021 at 13:00 (Batch/Lot number was not reported) as single dose, then second dose via an unspecified route of administration, administered in right arm on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included Congestive heart failure (CHF), kidney stones, diabetes, penicillin allergy, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), both for unspecified indication. The patient previously took statin [nystatin] for unspecified indication. On 05Mar2021 at 04:00, the patient experienced severe pain under right breast around into upper right back. The patient was hospitalized on 12Mar2020 for two days. Pain is still very intense. The patient underwent lab tests and procedures which included nasal swab: negative on 18Mar2021. The patient had bloodwork, x-ray, MRI and EKG as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: The causal association cannot be excluded between the reported events of breast pain and back pain with BNT162B2 vaccine use due to strong temporal association. 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. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, X-ray
Clinical narrative: Severe pain under right breast around into upper right back.  Was hospitalized 12Mar2020 for two days.  Pain is still very intense; Severe pain under right breast around into upper right back.  Was hospitalized 12Mar2020 for two days.  Pain is still very intense.; This is a spontaneous report from a contactable other health professional (HCP). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in right arm on 11Feb2021 at 13:00 (Batch/Lot number was not reported) as single dose, then second dose via an unspecified route of administration, administered in right arm on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included Congestive heart failure (CHF), kidney stones, diabetes, penicillin allergy, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), both for unspecified indication. The patient previously took statin [nystatin] for unspecified indication. On 05Mar2021 at 04:00, the patient experienced severe pain under right breast around into upper right back. The patient was hospitalized on 12Mar2020 for two days. Pain is still very intense. The patient underwent lab tests and procedures which included nasal swab: negative on 18Mar2021. The patient had bloodwork, x-ray, MRI and EKG as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: The causal association cannot be excluded between the reported events of breast pain and back pain with BNT162B2 vaccine use due to strong temporal association. 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. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 test
Clinical narrative: has pneumonia in her right lung; This is a spontaneous report from a Pfizer sponsored program.  A contactable consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 27Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient (reporter's sister) has pneumonia in her right lung on an unspecified date. The patient was hospitalized for pneumonia in her right lung from 19Mar2021. The patient underwent lab tests and procedures which included covid test: unknown results on an unspecified date, She did a covid test but has not gotten the results yet. She is wondering what she should do about the second dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Erectile dysfunction, Heart rate, Heart rate increased, Night sweats
Clinical narrative: Unusual impotence; Extreme night sweats; Elevated heart rate resting rate of 100. My normal is 74 BPM; Shortness of breath; This is a spontaneous report from a contactable other health care professional. A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 02Mar2021 16:00 (at the age of 51-years-old) (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took tylenol and experienced allergies. The patient did not receive other vaccines in four weeks, and other medications in two weeks. On 12Mar2021 16:00, the patient experienced Elevated heart rate resting rate of 100. My normal is 74 BPM. Shortness of breath. Extreme night sweats. Unusual impotence. All started 10 day after injection. The outcome of the events was not recovered.; Sender's Comments: The company does not attribute the unusual impotence (PT: Erectile dysfunction) to BNT162b2, considering the event being an intercurrent disorder.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain
Clinical narrative: heart flutters; Chest pain over an hour after the second shot; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 20Mar2021 08:00 (Lot Number: En6207) as SINGLE DOSE for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient's medical history was not reported. The patient have unspecified concomitant medication. The patient was previously had BNT162B2 first dose of BNT162B2 (lot number: En6203) in the right arm on 27-FEB-2021 08:00 AM for COVID-19 immunization, previously took codeine and experienced allergy. The facility where the most recent COVID-19 vaccine was administered was in the Health Clinic/facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Mar2021 9:00 AM, the patient experienced chest pain over an hour after the second shot. Chest pains and heart flutters the next morning after the shot on 21Mar2021. The outcome of the events was recovering. It was unknown if treatment for the event was given to the patient.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: brachial neuropathy; This is a spontaneous report from a contactable consumer.  A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 16:00 (Batch/Lot Number: Pfizeren6206) as single dose for covid-19 immunisation (age at vaccination: 48 years)  .  Medical history included asthma,  drug hypersensitivity (allergy to Penicillin). Concomitant medications included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for an unspecified indication, start and stop date were not reported.  The patient experienced brachial neuropathy on 12Mar2021 with outcome of not recovered. The reported event was considered an Important Medical Event. (IME).  Course of the event: Initial pain subsided in 3 days, then returned with right shoulder joint pain, burning sensation in right side of neck, limited mobility in shoulder joint and severe pain. Dr. Diagnosed as brachial neuropathy. Its 2 weeks now, and still in severe pain. The patient is being treated with Pain meds  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, Asthenia, Breast disorder, Fatigue, Loss of consciousness
Clinical narrative: patient felt like she was going to black out; slipping consciousness; nauseous; weaknesses; fatigue/fatigue in waves; fever; swollen lymph nodes; right breast sharp cramping; palpitations; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 08Mar2021 17:30 (lot number: EN6206) at the age of 36 years old, as single dose for covid-19 immunization. Medical history included gilbert's syndrome, past lyme disease (treated), anxiety and asthma.There were no concomitant medications. The patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunization (product: COVID 19, brand: Pfizer, lot number: EL9266, administration time: 02:15 PM, vaccine location: left arm, dose number: 1). Day 1 to 3 post vaccination (Mar2021), the patient experienced fatigue with fever. On day 4 to 5 the patient felt fine. On day 6 to 12 (Mar2021), the patient experienced extreme fatigue in waves, swollen lymph nodes and right breast sharp cramping, and some palpitations. On day 12 (20Mar2021 08:45), the patient had extreme wave of fatigue hit and the patient felt like she was going to black out, nauseous, weaknesses, slipping consciousness, called ambulance. It was reported as unknown if treatment was given to the patient for the adverse events. The events resulted in visit to emergency room/department or urgent care. The patient has not been tested for COVID post vaccination. The patient was not diagnosed with COVID prior to vaccination. No other vaccines in four weeks and no other medications in two weeks prior to COVID vaccination. The patient was not pregnant at the time of vaccination. The patient recovered from fever on unspecified date in Mar2021. Outcome of the rest of the events was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Palpitations, Pyrexia
Clinical narrative: patient felt like she was going to black out; slipping consciousness; nauseous; weaknesses; fatigue/fatigue in waves; fever; swollen lymph nodes; right breast sharp cramping; palpitations; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 08Mar2021 17:30 (lot number: EN6206) at the age of 36 years old, as single dose for covid-19 immunization. Medical history included gilbert's syndrome, past lyme disease (treated), anxiety and asthma.There were no concomitant medications. The patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunization (product: COVID 19, brand: Pfizer, lot number: EL9266, administration time: 02:15 PM, vaccine location: left arm, dose number: 1). Day 1 to 3 post vaccination (Mar2021), the patient experienced fatigue with fever. On day 4 to 5 the patient felt fine. On day 6 to 12 (Mar2021), the patient experienced extreme fatigue in waves, swollen lymph nodes and right breast sharp cramping, and some palpitations. On day 12 (20Mar2021 08:45), the patient had extreme wave of fatigue hit and the patient felt like she was going to black out, nauseous, weaknesses, slipping consciousness, called ambulance. It was reported as unknown if treatment was given to the patient for the adverse events. The events resulted in visit to emergency room/department or urgent care. The patient has not been tested for COVID post vaccination. The patient was not diagnosed with COVID prior to vaccination. No other vaccines in four weeks and no other medications in two weeks prior to COVID vaccination. The patient was not pregnant at the time of vaccination. The patient recovered from fever on unspecified date in Mar2021. Outcome of the rest of the events was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Appendicitis, 27 days later; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 23Feb2021 13:15 at 67-year-old as single dose for COVID-19 immunization. Medical history included allergies: Cephalosporins. Patient is not pregnant. Facility type vaccine: Public Health Clinic. Patient had no Covid prior vaccination. The patient's concomitant medications were not reported. The patient previously took first  dose of bnt162b2 (lot number: EL9265) on 29Jan2021 12:30 at 67-year-old on left arm for COVID-19 immunization. On 18Mar2021 02:00, the patient experienced appendicitis, "27 days later". AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for appendicitis, 27 days later for 1 day. The patient underwent lab tests and procedures which included Nasal Swab: negative on 19Mar2021. Therapeutic measures were taken as a result of appendicitis, 27 days later (Surgery). The outcome of the event was recovering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Lymphadenopathy
Clinical narrative: she thought she was getting Bell's Palsy; Lymph nodes swelled; This a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 17:30 (at the age of 60years) as single dose for Covid-19 immunization. There was no medical history; no known allergies. The patient is not pregnant at the time of vaccination. Concomitant medications included colecalciferol (VITA D); ascorbic acid (VITAMIN C); fish oil; ubidecarenone (COQ10); magnesium; and zinc; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph nodes swelled on the same side where she received the shot. Also, the left side of her checks down to neck and shoulders felt weird, she can't quite explain the feeling; she thought she was getting Bell's Palsy which is one of the adverse reactions. She was alarmed as she was unaware of the swelling of the lymph nodes. The adverse events occurred on 19Mar2021 (16:30). There was no treatment received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering.  Information about lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injury, Pain, Stress, Thunderclap headache
Clinical narrative: 2+ weeks after vaccine chronic debilitating headaches; every day 24/7 on and off thunderclap headaches constantly; Very stressful; trauma; physical pain; This is a spontaneous report from a contactable Nurse (patient). A 22-years-old female patient (no pregnant) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 26Feb2021 13:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient previously took the first dose bnt162b2 on unspecified date for covid-19 immunization. The patient medical history was included covid.     The patient's concomitant medications were not reported.  On 03Jan2021, the patient experienced chronic debilitating headaches in a person that is fit and healthy with no regular headaches ever before. Was fine for 2 days after the second dose then every day 24/7 on and off thunderclap headaches constantly on 03Jan2021. Very aggressive and detrimental pain that is seemingly continuing to get worse. Very stressful and concerning as patient can't go back and not get the vaccine. Has cause a lot of physical pain and trauma as well as psychological on 03Jan2021. No treatment for events. The outcome of events was not recovered.  Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. No other vaccine in two weeks; Had covid prior vaccination; No covid tested post vaccination  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of 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: Infection
Clinical narrative: Developed infection; This is a spontaneous report from a contactable consumer (reported for father) via a Pfizer-sponsored program, COVAX US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose of Covid vaccine on 25Feb2021. The patient was due for the second dose yesterday (18Mar2021). The patient developed infection on an unspecified date and was put in ICU (Intensive Case Unit). The outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Musculoskeletal disorder, Rheumatoid arthritis, Scratch, Weight
Clinical narrative: he has severe rheumatoid arthritis; he was having problems with his feet.; he had scratched himself so much that he has open wounds on himself; he had scratched himself so much that he has open wounds on himself; down to 135 a couple of week before; This is a spontaneous report from a contactable consumer reporting for a patient. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), second dose via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 70 years old. The patient medical history included "he had complication from egg and orange" from an unspecified date and unspecified health conditions. The patient takes unspecified concomitant medications. The patient received the first dose of BNT162B2 on Feb2021 for covid-19 immunisation, at 70 years old and experienced itching and rash. It was reported that patient has serious health issues already. He has severe rheumatoid arthritis on an unspecified date. He has been given every rheumatoid arthritis medication (unspecified) on the market but none of them really helped him. Patient is now on an infusion of some kind of drugs (unspecified). He is on so many different unspecified medications and then he was having problems with his feet on an unspecified date, so the reporter bought the patient "Gold Bond Diabetic Lotion" (product name as reported), to put on his feet. The reporter does not know if this was all related because he is on so many medications. After the second shot, patient woke up on the morning of 19Mar2021 and he had scratched himself so much that he has open wounds on himself. The reporter talked with the patient regarding the cause of the event so the reporter said to stop using "Gold Bond Diabetic Lotion". The patient had had done that for several days and it did not seem to make a difference. Reporter stated they do not know if this is related to the COVID immunization, but they are trying to eliminate things and he is in touch with his doctor right now. The reporter stated that since the patient has rheumatoid arthritis and he is having a lot of health problems. The patient was down to 135 a couple of week before reporting time (2021). It has been about a month since he had extensive lab test because he has to go for extensive lab test every time before he has that infusion of those drugs on 03Mar2021. Patient would have gone for lab test the Friday before that, 26Feb2021 when he had extensive lab test. No treatment for events "he had scratched himself so much that he has open wounds on himself" and " down to 135 a couple of week before". Treatment was given for rheumatoid arthritis and problems with his feet (unspecified infusions and Gold Bond Diabetic Lotion). Outcome of the events was unknown.  Information about Lot/Batch number is requested.