chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Pain, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: body hurting/body hurts/body aches; can hardly walk; weakness; swollen arm/; Swollen arm where the injection was given; This is a spontaneous report from a contactable consumer (patient herself). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA7485), via an unspecified route of administration, administered in left arm on 13Jul2021 (age at vaccination: 58 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included covid-19, ongoing diabetes mellitus, sinusitis, thyroiditis and pain. Concomitant medication(s) included topiramate (has been on for a couple of years) taken for headache; gabapentin (has been on for a few years); levothyroxine sodium (THYROXINE) (has been on for a couple of years) taken for thyroiditis; estradiol; montelukast sodium (SINGULAIR) 10mg taken for sinusitis; pravastatin; metformin 500mg taken for diabetes mellitus and hydrocodone taken for pain in her back and down her legs. On 13Jul2021, the patient's body was hurting/body hurts/body aches, can hardly walk, weakness, swollen arm where the injection was given which started yesterday evening and has gone down some since she soaked it. The patient stated that body pain started last night, or actually yesterday when she was at work; weakness started yesterday evening, it was about the same and has not gotten better. There was no treatment was given for the adverse events. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room and physician's office. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unknown date. The outcome of the event pain, gait disturbance, asthenia, was not recovered; peripheral swelling, vaccination site pain was recovering. There was no product quality complaint (PQC) present.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: body hurting/body hurts/body aches; can hardly walk; weakness; swollen arm/; Swollen arm where the injection was given; This is a spontaneous report from a contactable consumer (patient herself). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA7485), via an unspecified route of administration, administered in left arm on 13Jul2021 (age at vaccination: 58 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included covid-19, ongoing diabetes mellitus, sinusitis, thyroiditis and pain. Concomitant medication(s) included topiramate (has been on for a couple of years) taken for headache; gabapentin (has been on for a few years); levothyroxine sodium (THYROXINE) (has been on for a couple of years) taken for thyroiditis; estradiol; montelukast sodium (SINGULAIR) 10mg taken for sinusitis; pravastatin; metformin 500mg taken for diabetes mellitus and hydrocodone taken for pain in her back and down her legs. On 13Jul2021, the patient's body was hurting/body hurts/body aches, can hardly walk, weakness, swollen arm where the injection was given which started yesterday evening and has gone down some since she soaked it. The patient stated that body pain started last night, or actually yesterday when she was at work; weakness started yesterday evening, it was about the same and has not gotten better. There was no treatment was given for the adverse events. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room and physician's office. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unknown date. The outcome of the event pain, gait disturbance, asthenia, was not recovered; peripheral swelling, vaccination site pain was recovering. There was no product quality complaint (PQC) present.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: Fever of 103 degrees Fahrenheit, after second vaccine; Caller states her daughter left work and came home sick around midnight.; This is a spontaneous report from a contactable consumer (Patient's mother). A female patient of an unspecified age received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 13Jul2021 at 18:30 (Batch/Lot Number: FA6780) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever of 103 degrees fahrenheit, after second vaccine on an unspecified date. Reporter states her daughter left work and came home sick around midnight on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 103 degrees fahrenheit on an unspecified date. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, SARS-CoV-2 antibody test, Scan
Clinical narrative: extraordinarily high blood pressure; headaches; This is a spontaneous report from contactable consumers (patient himself and his wife) via a Pfizer sponsored program. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included blood cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took rituximab for blood cancer from an unspecified date (explained that he completed Rituximab almost 1.5 years ago). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (batch/lot number not reported) for covid-19 immunisation. The patient reported that he has always had normal blood pressure with routine checks every three months with HCP and or oncologist. He noted following the vaccine series he experienced headaches that went away and then headaches returned in 2-3 weeks with a number "sudden health issues"  on an unspecified date in 2021 but came back to extraordinarily high blood pressure found at the end of March2021. While under medical evaluation in end of Mar2021 he mentioned his blood pressure was 200/100. He has had various scan of kidneys, heart and lungs looking for a cause but none was found.  MDs can not find any triggering reason for hypertension. His wife further reported that the patient received a negative antibody test following full series of Pfizer Covid 19 vaccine. She is curious why a negative antibody test would result following complete vaccination. The patient underwent lab tests and procedures which included blood pressure measurement: normal on an unspecified date, blood pressure measurement: extraordinarily high blood pressure (blood pressure was 200/100) on Mar2021, sars-cov-2 antibody test: negative and scan: scan of kidneys, heart and lungs and none was found on an unspecified date. The patient did not recover from the events.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Echocardiogram, Transient ischaemic attack
Clinical narrative: the patient had a stroke,reporter further stated that they called it a mini stroke; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6206), via an unspecified route of administration on 27Mar2021 (at an unspecified age) at dose 2, single in the left arm for COVID-19 immunization. Medical history included borderline blood pressure. The patient had no other vaccines received on the day of vaccination of the Pfizer vaccine. Concomitant medications included amlodipine for borderline blood pressure and omeprazole; both ongoing. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6202, expiration date: unknown) received in the morning of 06Mar2021 at around 10:30 am in the left arm for COVID-19 immunization. On 10Apr2021, exactly 2 weeks after the second shot, the patient had a stroke. The patient had no previous issues. Since then, the patient has had no cholesterol issues, no heart issues, and no blood pressure issues (as reported). The patient had nothing before and since then, all tests including an echocardiogram, and stress tests show that there did not appear to be any heart issues (negative). The reporter further stated that they called it a mini stroke and the symptoms disappeared very quickly.  There were no residual effects of the stroke. The patient wore a heart monitor for 2 weeks and there doesn't seem to be anything that would have caused this. The reporter finds it strange that it happened so quickly after the patient took the shot. The reporter heard of several stories of people who knew people who had strokes similar to this situation, aged around 50 years old and so forth with no previous heart issues. The reporter wanted to know if this was something Pfizer has seen a lot. It was reported that the patient's stroke initially caused some effects which was why he was brought to the emergency room where it was diagnosed as stroke and was admitted to the hospital for 4 days from an unspecified date in 2021 to an unspecified date in 2021. Outcome of the event was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Laboratory test, Pallor
Clinical narrative: Headaches; very pale; no appetite; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN9581, expiry date not reported), via an unspecified route of administration, administered in left arm on 04Feb2021 (at the age of 57 years old) as dose 1, single for covid-19 immunization. Medical history included Barrett's esophagus and have known allergy (unspecified), both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in workplace clinic. In Feb2021, patient had headaches, was very pale and had no appetite.  The events were reported as life threatening and had caused hospitalization on unknown dates in 2021 for 2 days. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events reported which included testing (date unknown in 2021 and unknown results) and patient was put on blood thinners. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Hypoaesthesia oral, Pallor, Thrombosis
Clinical narrative: on 20Apr2021 found clot in jugular vein.; Headaches after both shots, very pale no appetite.; Headaches after both shots, very pale no appetite.; Headaches after both shots, very pale no appetite.; 25Mar woke with numbness in lips; This is a spontaneous report from a contactable consumer (patient) reported that a 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), via an unspecified route of administration, administered in arm left on 25Feb2021 (at the age of 57-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included barrett's oesophagus, and had known allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN9581), administered in arm left on 04Feb2021 (at the age of 57-years-old) as first dose for covid-19 immunisation, and experienced headaches, very pale no appetite. On 25Mar2021, the patient experienced headaches after both shots, very pale no appetite. On 25Mar2021 woke with numbness in lips, and on 20Apr2021 found clot in jugular vein. The seriousness of the events was provided and were considered as life-threatening and caused hospitalization for 2 days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. The patient underwent testing and put on blood thinners. The outcome of the events was unknown.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid 19; lost sense of taste and smell; lost sense of taste and smell; This is a spontaneous report from a contactable other hcp. This other HCP reported for a 17-year-old male patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot EW0198), dose 1 intramuscular, administered in Arm Left on 13Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included dust mite allergy. The patient's concomitant medications were not reported. On 15Jul2021 (two days post vaccination) patient experienced tested positive for covid 19, lost sense of taste and smell. The patient underwent lab tests which included body temperature: normal, sars-cov-2 test: positive on 15Jul2021 (Covid 19 Ag card). Reporter seriousness for tested positive for covid 19 was not serious. received his first dose of Pfizer Covid vaccine. Reporter was wondering if that was to be expected. Second dose scheduled for 03Aug2021. Treatment declines any. He has no other symptoms, checked temperature and it was normal, sinuses and lungs are fine, no body aches. He is a healthy child, no conditions. There is a Product Complaint. Caller asking if these results mean the patient actually has Covid-19. Response: Spoke from "regulatory authority-can the vaccine cause a false positive COVID-19 test (v3.0)." "Viral tests are used to see if you have a current infection. The Pfizer-BioNTech COVID-19 Vaccine will not cause you to test positive on viral tests. The following website has information on viral tests for current infection with COVID-19:# Sending email fulfillment containing attached document per caller request. Informed caller that the Pfizer BioNTech Covid-19 Vaccine cannot cause a Covid-19 infection. Informed caller that Pfizer cannot speak to the reliability of the results of the test used. The outcome for all events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cholesteatoma, Computerised tomogram, Dizziness, Feeling abnormal, Gait disturbance
Clinical narrative: It was found out that she had a Cholesteatoma, which is a tumor in the ear.; On the 3rd day however, she had this dizziness that progressively got worse.; The vertigo made her barely able to walk and as it went on she could feel the room spinning.; The vertigo made her barely able to walk and as it went on she could feel the room spinning.; She wants to know if vertigo or dizziness as well as reports of inflammation a common side effect of the vaccine.; She mentioned that she had soreness on her neck and felt bad for 2 days; She mentioned that she had soreness on her neck and felt bad for 2 days; This is a spontaneous report from contactable consumer via Pfizer sponsored program. A female consumer of unspecified age reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 21Jun2021 at unknown dose single for COVID-19 immunization. She was not pregnant at time of vaccination. Medical history includes ear disorder. No concomitant medication reported. She had a pretty bad reaction from first dose on 21Jun2021. Patient mentioned that she had soreness on her neck and felt bad for 2 days. On the 3rd day however, she had this dizziness that progressively got worse. The vertigo made her barely able to walk and as it went on she could feel the room spinning. She felt it while standing up, moving, and even while laying down. She was not able to function and not able to do anything. She mentioned that it is a lot less worse that what she felt earlier and is progressively better. She mentioned that it was the 1st day that she was able to drive. She mentioned that she consulted with her ENT and family doctor. She had a history of ear problems and had a CT done yesterday. It was found out that she had a Cholesteatoma, which was a tumor in the ear. She mentioned that no one she knows had this problem and she was concerned about getting the 2nd shot. Caller stated she didn't know if it was necessary to file a report. She needed to find out if what happened was a normal reaction and give her some more information. She was debating if she should get the second shot. The pharmacy said to call and get her questions answered. The outcome for Event neck pain was recovered on an unspecified date in 2021 and for vertigo was recovering. The outcome of others Events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Neck pain, Vertigo
Clinical narrative: It was found out that she had a Cholesteatoma, which is a tumor in the ear.; On the 3rd day however, she had this dizziness that progressively got worse.; The vertigo made her barely able to walk and as it went on she could feel the room spinning.; The vertigo made her barely able to walk and as it went on she could feel the room spinning.; She wants to know if vertigo or dizziness as well as reports of inflammation a common side effect of the vaccine.; She mentioned that she had soreness on her neck and felt bad for 2 days; She mentioned that she had soreness on her neck and felt bad for 2 days; This is a spontaneous report from contactable consumer via Pfizer sponsored program. A female consumer of unspecified age reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 21Jun2021 at unknown dose single for COVID-19 immunization. She was not pregnant at time of vaccination. Medical history includes ear disorder. No concomitant medication reported. She had a pretty bad reaction from first dose on 21Jun2021. Patient mentioned that she had soreness on her neck and felt bad for 2 days. On the 3rd day however, she had this dizziness that progressively got worse. The vertigo made her barely able to walk and as it went on she could feel the room spinning. She felt it while standing up, moving, and even while laying down. She was not able to function and not able to do anything. She mentioned that it is a lot less worse that what she felt earlier and is progressively better. She mentioned that it was the 1st day that she was able to drive. She mentioned that she consulted with her ENT and family doctor. She had a history of ear problems and had a CT done yesterday. It was found out that she had a Cholesteatoma, which was a tumor in the ear. She mentioned that no one she knows had this problem and she was concerned about getting the 2nd shot. Caller stated she didn't know if it was necessary to file a report. She needed to find out if what happened was a normal reaction and give her some more information. She was debating if she should get the second shot. The pharmacy said to call and get her questions answered. The outcome for Event neck pain was recovered on an unspecified date in 2021 and for vertigo was recovering. The outcome of others Events was unknown.   Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: Ice cold hands and feet since being vaccinated.; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route, administered in left Arm on Mar2021 at 10:00 (Lot Number: ER8732; at the age of 40-year-old) as a dose 2, single via an unspecified route, administered in left Arm on Mar2021 at 10:00 (Lot Number: ER8732; at the age of 40-year-old) as dose 1, single, both doses for COVID-19 immunization. The patient's medical history included heart arrhythmia and Hashimoto's. No past drug was reported. The patient's concomitant medications included levothyroxine sodium within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021 at 20:00, the patient experienced ice cold hands and feet since being vaccinated. Since the vaccination, the patient had not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient had not received any treatment medication for the reported event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information was expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, C-reactive protein, Chest X-ray, Chills
Clinical narrative: Bronchial pneumonia; Blood clot; joint pain in shoulders, wrist and arms; Flu symptoms; chills; fever; his SED rate and it is coming back low to normal; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration in left Arm on 14Jan2021 (age at vaccination 71 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient Medical history included low thyroid, cholesterol and blood clot issue from an unknown date and unknown if ongoing. The patient concomitant medications included Levothyroxine 125mcg tablet for Low thyroid, Atorvastatin for Cholesterol, Cholecalciferol (D3), Glucose (D5) from an unknown start date. On an unspecified date 2021, the patient experienced Bronchial tube slightly enlarged, joint pain in shoulders, wrist and arms this happened seven days after each vaccine. In the first case he was given steroids and got relief. Then 7 days after the 2nd vaccine the same has happened. He wanted to know that had you had other patients reporting similar symptoms. He had flu symptoms such as chills, fever and he also had some other issues including blood clots and Bronchial pneumonia treated with antibiotics and prednisone (treatment). The patient underwent lab tests and procedures which included MRI on one shoulder and his rheumatologist was checked his SED rate and it was coming back low to normal. Patient went to his GP and he had had history of blood clots, so he did Blood work or something Chest X-ray and then CT and saw bronchial tube was slightly enlarged, when probe if reports were normal, consumer stated, yes red blood cell sedimentation rate. The patient had blood test for platelet and results was low. The patient took Tylenol 4-6 a day because of his low platelets. He was on blood thinner Warfarin, Centrum for 20 years they took off that in 2019, but still take Tylenol because of low platelet. The outcome of event pneumonia and joint pain was recovered on an unspecified date and rest of all events were unknown.  Information about lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Differential white blood cell count, Influenza, Magnetic resonance imaging, Platelet count
Clinical narrative: Bronchial pneumonia; Blood clot; joint pain in shoulders, wrist and arms; Flu symptoms; chills; fever; his SED rate and it is coming back low to normal; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration in left Arm on 14Jan2021 (age at vaccination 71 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient Medical history included low thyroid, cholesterol and blood clot issue from an unknown date and unknown if ongoing. The patient concomitant medications included Levothyroxine 125mcg tablet for Low thyroid, Atorvastatin for Cholesterol, Cholecalciferol (D3), Glucose (D5) from an unknown start date. On an unspecified date 2021, the patient experienced Bronchial tube slightly enlarged, joint pain in shoulders, wrist and arms this happened seven days after each vaccine. In the first case he was given steroids and got relief. Then 7 days after the 2nd vaccine the same has happened. He wanted to know that had you had other patients reporting similar symptoms. He had flu symptoms such as chills, fever and he also had some other issues including blood clots and Bronchial pneumonia treated with antibiotics and prednisone (treatment). The patient underwent lab tests and procedures which included MRI on one shoulder and his rheumatologist was checked his SED rate and it was coming back low to normal. Patient went to his GP and he had had history of blood clots, so he did Blood work or something Chest X-ray and then CT and saw bronchial tube was slightly enlarged, when probe if reports were normal, consumer stated, yes red blood cell sedimentation rate. The patient had blood test for platelet and results was low. The patient took Tylenol 4-6 a day because of his low platelets. He was on blood thinner Warfarin, Centrum for 20 years they took off that in 2019, but still take Tylenol because of low platelet. The outcome of event pneumonia and joint pain was recovered on an unspecified date and rest of all events were unknown.  Information about lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Pyrexia, Red blood cell count, Red blood cell sedimentation rate, Red blood cell sedimentation rate decreased
Clinical narrative: Bronchial pneumonia; Blood clot; joint pain in shoulders, wrist and arms; Flu symptoms; chills; fever; his SED rate and it is coming back low to normal; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration in left Arm on 14Jan2021 (age at vaccination 71 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient Medical history included low thyroid, cholesterol and blood clot issue from an unknown date and unknown if ongoing. The patient concomitant medications included Levothyroxine 125mcg tablet for Low thyroid, Atorvastatin for Cholesterol, Cholecalciferol (D3), Glucose (D5) from an unknown start date. On an unspecified date 2021, the patient experienced Bronchial tube slightly enlarged, joint pain in shoulders, wrist and arms this happened seven days after each vaccine. In the first case he was given steroids and got relief. Then 7 days after the 2nd vaccine the same has happened. He wanted to know that had you had other patients reporting similar symptoms. He had flu symptoms such as chills, fever and he also had some other issues including blood clots and Bronchial pneumonia treated with antibiotics and prednisone (treatment). The patient underwent lab tests and procedures which included MRI on one shoulder and his rheumatologist was checked his SED rate and it was coming back low to normal. Patient went to his GP and he had had history of blood clots, so he did Blood work or something Chest X-ray and then CT and saw bronchial tube was slightly enlarged, when probe if reports were normal, consumer stated, yes red blood cell sedimentation rate. The patient had blood test for platelet and results was low. The patient took Tylenol 4-6 a day because of his low platelets. He was on blood thinner Warfarin, Centrum for 20 years they took off that in 2019, but still take Tylenol because of low platelet. The outcome of event pneumonia and joint pain was recovered on an unspecified date and rest of all events were unknown.  Information about lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Bronchial pneumonia; Blood clot; joint pain in shoulders, wrist and arms; Flu symptoms; chills; fever; his SED rate and it is coming back low to normal; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration in left Arm on 14Jan2021 (age at vaccination 71 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient Medical history included low thyroid, cholesterol and blood clot issue from an unknown date and unknown if ongoing. The patient concomitant medications included Levothyroxine 125mcg tablet for Low thyroid, Atorvastatin for Cholesterol, Cholecalciferol (D3), Glucose (D5) from an unknown start date. On an unspecified date 2021, the patient experienced Bronchial tube slightly enlarged, joint pain in shoulders, wrist and arms this happened seven days after each vaccine. In the first case he was given steroids and got relief. Then 7 days after the 2nd vaccine the same has happened. He wanted to know that had you had other patients reporting similar symptoms. He had flu symptoms such as chills, fever and he also had some other issues including blood clots and Bronchial pneumonia treated with antibiotics and prednisone (treatment). The patient underwent lab tests and procedures which included MRI on one shoulder and his rheumatologist was checked his SED rate and it was coming back low to normal. Patient went to his GP and he had had history of blood clots, so he did Blood work or something Chest X-ray and then CT and saw bronchial tube was slightly enlarged, when probe if reports were normal, consumer stated, yes red blood cell sedimentation rate. The patient had blood test for platelet and results was low. The patient took Tylenol 4-6 a day because of his low platelets. He was on blood thinner Warfarin, Centrum for 20 years they took off that in 2019, but still take Tylenol because of low platelet. The outcome of event pneumonia and joint pain was recovered on an unspecified date and rest of all events were unknown.  Information about lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Exposure during pregnancy, Headache, Insomnia, Malaise
Clinical narrative: got her first dose of the Pfizer BioNTech Covid-19 vaccine yesterday (14 JUL 2021); not feeling well; pain; headache; joint pain; hard to go to sleep; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program. A 32-year-old female pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 14Jul2021 (at the age of 32-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient was pregnant at time of vaccination. The gestation period was 8 months. The patient first dose of the Pfizer BioNTech COVID-19 vaccine yesterday (on 14Jul2021) and was not feeling well. She experienced pain, headaches and joint pain. Stated that, her last menstrual period was a year ago. She was 8 months pregnant (35-36 weeks) and her due date was on next month. The patient wanted to know what she can take for pain, specifically headaches and joint pain. The agent provided her the phone number for medical information and has been referred to healthcare professional. Stated that, she tried calling and has not heard back. Stated that, she has not heard from her OBGYN and has been calling them since that morning for that pain. She has had that pain since last night. She just wanted the pain to stop. Stated that, she got her vaccine at 0900-1000. That night, she was cooking and not feeling well and was sore. After that, she stated it was hard to go to sleep, got vaccine on her left and she sleeps on that side and her whole body in pain. Stated that, she needed help from her husband, which was unusual for her. The caller declined to proceed with a report at that time. The outcome of the events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: got her first dose of the Pfizer BioNTech Covid-19 vaccine yesterday (14 JUL 2021); not feeling well; pain; headache; joint pain; hard to go to sleep; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program. A 32-year-old female pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 14Jul2021 (at the age of 32-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient was pregnant at time of vaccination. The gestation period was 8 months. The patient first dose of the Pfizer BioNTech COVID-19 vaccine yesterday (on 14Jul2021) and was not feeling well. She experienced pain, headaches and joint pain. Stated that, her last menstrual period was a year ago. She was 8 months pregnant (35-36 weeks) and her due date was on next month. The patient wanted to know what she can take for pain, specifically headaches and joint pain. The agent provided her the phone number for medical information and has been referred to healthcare professional. Stated that, she tried calling and has not heard back. Stated that, she has not heard from her OBGYN and has been calling them since that morning for that pain. She has had that pain since last night. She just wanted the pain to stop. Stated that, she got her vaccine at 0900-1000. That night, she was cooking and not feeling well and was sore. After that, she stated it was hard to go to sleep, got vaccine on her left and she sleeps on that side and her whole body in pain. Stated that, she needed help from her husband, which was unusual for her. The caller declined to proceed with a report at that time. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Hypoaesthesia oral, Lethargy, Migraine
Clinical narrative: had heavy breathing/shortness of breath; itching/ hands and feet were red and itchy; and a rash on her hands and feet/ hands and feet were red and itchy; lethargy; migraines; body aches; hives on her face/ face and neck she had welts; numbness on her face, hands, lips and feet/ numbness in her face lips and tongue; numbness on her face, hands, lips and feet; This is a spontaneous report from a contactable consumer reporting for self, via the Pfizer-sponsored program. A 58-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration in left shoulder on 14Jul2021 (Batch/Lot Number: ER8731) as a single dose for COVID-19 immunization.  Medical history included allergic to insect bites, shellfish, and she had COVID in Mar2020. Concomitant medication(s) were none. There were no vaccinations in the 4 weeks prior.  The patient previously took epinephrine (EPIPEN) for severe allergic reaction and pneumonia vaccine on 23May2020 (at age 57 years old) and experienced migraines. The patient reported she had many side effects after her first dose such as numbness, itching, migraines, body aches, lethargy, hives on her face, and a rash on her hands and feet. She had the numbness on her face, hands, lips and feet started immediately after administering the vaccine (14Jul2021). She took Tylenol so it wouldn't get worse and she took Benadryl because her hands and feet were red and she also experienced body aches (onset 14Jul2021). She states she has an EPIPEN she carries just in case of a severe allergic reaction because she was allergic to insect bites, shellfish, and things like that, but she did not use it after she received the vaccine. She only took Benadryl. She also had heavy breathing/shortness of breath as a symptom. On her face and neck she had welts and she didn't see the rest of her body because she had pajamas on. When she got up to use the restroom she was trying to figure out why she was itching. She saw welts on her face and neck. Her hands and feet were red and itchy. There was no investigation assessment. At the time of the report, the numbness in her face lips and tongue was gone (recovered in Jul2021) but the numbness in feet and hands remain (not recovered). There was no treatment for this event. The welts on her face and neck had started 30 mins after she departed got in the car and went home, and had gone away on 14Jul2021, after Benadryl (recovered). The migraines had started about 6pm on 14Jul2021; they were dulling and were going away, but was still on the back of the head. It was persisting (not recovered). Treatment for the migraines was just the Tylenol. The body aches were treated with Tylenol and were ongoing (not recovered). The events did not require a visit to the Emergency Room or Physician's office. She wanted to know when these symptoms would go away .If she takes dose 2, she wanted to know what can she do as preparation for this because she heard the second one is worse.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash erythematous, Urticaria
Clinical narrative: had heavy breathing/shortness of breath; itching/ hands and feet were red and itchy; and a rash on her hands and feet/ hands and feet were red and itchy; lethargy; migraines; body aches; hives on her face/ face and neck she had welts; numbness on her face, hands, lips and feet/ numbness in her face lips and tongue; numbness on her face, hands, lips and feet; This is a spontaneous report from a contactable consumer reporting for self, via the Pfizer-sponsored program. A 58-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration in left shoulder on 14Jul2021 (Batch/Lot Number: ER8731) as a single dose for COVID-19 immunization.  Medical history included allergic to insect bites, shellfish, and she had COVID in Mar2020. Concomitant medication(s) were none. There were no vaccinations in the 4 weeks prior.  The patient previously took epinephrine (EPIPEN) for severe allergic reaction and pneumonia vaccine on 23May2020 (at age 57 years old) and experienced migraines. The patient reported she had many side effects after her first dose such as numbness, itching, migraines, body aches, lethargy, hives on her face, and a rash on her hands and feet. She had the numbness on her face, hands, lips and feet started immediately after administering the vaccine (14Jul2021). She took Tylenol so it wouldn't get worse and she took Benadryl because her hands and feet were red and she also experienced body aches (onset 14Jul2021). She states she has an EPIPEN she carries just in case of a severe allergic reaction because she was allergic to insect bites, shellfish, and things like that, but she did not use it after she received the vaccine. She only took Benadryl. She also had heavy breathing/shortness of breath as a symptom. On her face and neck she had welts and she didn't see the rest of her body because she had pajamas on. When she got up to use the restroom she was trying to figure out why she was itching. She saw welts on her face and neck. Her hands and feet were red and itchy. There was no investigation assessment. At the time of the report, the numbness in her face lips and tongue was gone (recovered in Jul2021) but the numbness in feet and hands remain (not recovered). There was no treatment for this event. The welts on her face and neck had started 30 mins after she departed got in the car and went home, and had gone away on 14Jul2021, after Benadryl (recovered). The migraines had started about 6pm on 14Jul2021; they were dulling and were going away, but was still on the back of the head. It was persisting (not recovered). Treatment for the migraines was just the Tylenol. The body aches were treated with Tylenol and were ongoing (not recovered). The events did not require a visit to the Emergency Room or Physician's office. She wanted to know when these symptoms would go away .If she takes dose 2, she wanted to know what can she do as preparation for this because she heard the second one is worse.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Echocardiogram, Magnetic resonance imaging, Myocarditis, Pericarditis
Clinical narrative: Pericarditis; Myocarditis; This is a spontaneous report from a contactable pharmacist. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 28Jun2021 (at the age of 62-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date pharmacist on the line stating that he has a healthy female patient who received the 1st dose of the Pfizer COVID-19 vaccine 28Jun2021. The patient has now developed what they are thinking could be Myocarditis and Pericarditis after receiving the vaccine. The patient has never had COVID-19 before with no other significant medical or cardiac health history noted. Pharmacist states that he has received some information from (developer name) who advise to not take the 2nd vaccine or defer it until after the condition is complete or resolved and at that time it would be up to the doctor and the patient. He would like to know if we at Pfizer have any direction on getting the 2nd dose at this time with this patient's current circumstances. They had their first patient that is possibly diagnosed with myocarditis and pericarditis. She had first dose on 28Jun2021 and had no prior cardiac history. It says either don't take second dose or defer until after condition was complete. He would like to know what the chance of her is getting it again after it resolved. It may take months to resolve. He wanted some guidance about second dose. They just did stress test, MRI and an Echo. They don't have definite declaration that it is myocarditis and pericarditis yet and he preferred to wait until that was confirmed before completing a report. He requested to be transferred to have his question answered and did not wish to complete report. The patient underwent lab tests and procedures which included cardiac stress test: unknown results, echocardiogram: unknown results, magnetic resonance imaging: unknown results on an unspecified date. The outcome of the event was unknown.  Information on batch/lot number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of myocarditis and pericarditis and the suspect product BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Inflammation, Joint swelling, Nasal turbinate hypertrophy, Peripheral swelling
Clinical narrative: Inflammation; Right ankle had swollen again; His right ankle and knee both were swollen; Inside arms right by the joint started swelling; Bridge of nose was swollen; Left eye was swollen up shut; Extreme facial swelling and was brought to the emergency room and was prescribed with medication to reduce the swelling; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 30Apr2021 (Batch/Lot Number: EW0175) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: EW0162) as dose 1, single for covid-19 immunization. On 02May2021 the patient experienced face swelling and went to the emergency room and prescribed with medication to reduce the swelling. Once it came down, on 11Jun2021, patient left eye was swollen up shut and patient returned to the medical facility and doctors gave him medications to reduce the swelling. On 18Jun2021, the patient's bridge of nose was swollen, 19Jun2021, inside arms right by the joint started swelling, 28Jun2021, patient right ankle and knee both were swollen, then went back to the emergency room and patient was again prescribed with medications for that. It went down for a couple of days, but patient right ankle had swollen again on 15Jul2021. On an unspecified date the patient had inflammation. The event swelling face was serious medically significant. The events facial swelling, joint swelling led the patient to emergency room visit and received treatment. The outcome the event swelling face was recovering, event his right ankle and knee both were swollen was recovered with sequelae on an unspecified date in 2021, and outcome of the other events was unknown.   Follow-up attempts are completed. No further information is expected.