chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Erythema, Muscle spasms, Pain, Pain in extremity
Clinical narrative: DVT diagnosed; Continual pain; A red area appeared and extremely painful in brachial vein area of left arm; A red area appeared and extremely painful in brachial vein area of left arm; Stayed hot in the injection site daily; Left arm cramped; This is a spontaneous report from a contactable other health care professional.  A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: En5318), via an unspecified route of administration, administered in left arm on 22Jan2021 (at the age of 55-year-old) as single dose for COVID-19 immunization. Medical history included asthma and known allergies of Celebrex and Vioxx. Patient received any other concomitant medication within 2 weeks prior to the COVID-19 vaccine included bupropion hydrochloride (WELLBUTRIN) and ibuprofen (IBUPROFEN). Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: En0899), via an unspecified route of administration, administered in left arm on 04Jan2021 (at the age of 55-years-old) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Facility where the most recent COVID-19 vaccine was administered at Workplace clinic. Adverse event started on 22Jan2021 at 04:00 PM. The patient experienced left arm cramped and stayed hot in the injection site daily after 2nd vaccine. On 14Apr2021, a red area appeared and extremely painful in brachial vein area of left arm. On 20Apr2021, Ultrasound scan (US) performed and DVT diagnosed and continual pain since. The patient underwent lab tests and procedures which included ultrasound scan: DVT diagnosed on 20Apr2021. Patient visited to Emergency room/department or urgent care. Treatment received blood thinner Xarelto 20mg. The outcome of the events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events deep vein thrombosis,pain,pain in extremity, Erythema,cramp in hand and vaccination site warmth cannot be totally excluded 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vaccination site warmth
Clinical narrative: DVT diagnosed; Continual pain; A red area appeared and extremely painful in brachial vein area of left arm; A red area appeared and extremely painful in brachial vein area of left arm; Stayed hot in the injection site daily; Left arm cramped; This is a spontaneous report from a contactable other health care professional.  A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: En5318), via an unspecified route of administration, administered in left arm on 22Jan2021 (at the age of 55-year-old) as single dose for COVID-19 immunization. Medical history included asthma and known allergies of Celebrex and Vioxx. Patient received any other concomitant medication within 2 weeks prior to the COVID-19 vaccine included bupropion hydrochloride (WELLBUTRIN) and ibuprofen (IBUPROFEN). Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: En0899), via an unspecified route of administration, administered in left arm on 04Jan2021 (at the age of 55-years-old) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Facility where the most recent COVID-19 vaccine was administered at Workplace clinic. Adverse event started on 22Jan2021 at 04:00 PM. The patient experienced left arm cramped and stayed hot in the injection site daily after 2nd vaccine. On 14Apr2021, a red area appeared and extremely painful in brachial vein area of left arm. On 20Apr2021, Ultrasound scan (US) performed and DVT diagnosed and continual pain since. The patient underwent lab tests and procedures which included ultrasound scan: DVT diagnosed on 20Apr2021. Patient visited to Emergency room/department or urgent care. Treatment received blood thinner Xarelto 20mg. The outcome of the events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events deep vein thrombosis,pain,pain in extremity, Erythema,cramp in hand and vaccination site warmth cannot be totally excluded 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: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Computerised tomogram thorax, Cough, Depression
Clinical narrative: she is going into depression and spoke of "hanging myself on a tree"; bone chilling chills; whole body aches; lingering cough; no energy; headache; flu like symptoms; swollen legs; water retention; she is going into depression; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number Unknown) via an unspecified route of administration on 26Mar2021 at single dose for Covid-19 immunization. The patient's medical history included diabetic. The patient's concomitant medications were not reported. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) on 05Mar2021 via an unspecified route of administration as single dose for Covid-19 immunization and experienced bone chilling chills, body ache, lingering cough, no energy, headache, flu like symptoms, swollen leg and water retention. Beginning after the first dose and been going on for over 3 months she reported symptoms of bone chilling chills, body aches, lingering cough, no energy, headache, flu like symptoms, swollen legs, and water retention. Caller was followed by nephrology and endocrinology. Caller saw nephrologist who reported everything was fine from her end. Caller was concerned for a heart condition and saw a cardiologist on Monday because of the swollen legs and water retention who did a chest CT, echocardiogram, and EKG all of which they said were fine. Caller recently saw a "lungs doctor" who prescribed albuterol and Spiriva for her lingering cough. Caller seeking information on how long these symptoms were going to last. Caller reported she has an appointment tomorrow with her primary care doctor. Caller stated that was not a common way to live she was going into depression and spoke of "hanging myself on a tree". She has seen several doctors already and there has been a lot of possibilities and so further cannot pinpoint anything. Caller confirmed she gave this information previously. She was just wondering how long will it take to subside or was this going to be an ongoing thing. She states she can't live like that. There were side effects that she has and she was curious how long was it go to be until they subside. As a treatment for cough patient was prescribed albuterol and Spiriva. The patient underwent lab tests and procedures which included Chest CT, Echocardiogram and (Electrocardiogram) EKG and the result of all was fine. The outcome of event was not recovered at the time of reporting.  Information about lot/batch number is requested follow-up attempts are needed.   Amendment: This follow-up report is being submitted to amend previously reported information: event "she is going into depression and spoke of "hanging myself on a tree"  was added and coded to "Suicidal ideation; seriousness was upgraded to Medically Significant.
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Fluid retention, Headache, Influenza like illness
Clinical narrative: she is going into depression and spoke of "hanging myself on a tree"; bone chilling chills; whole body aches; lingering cough; no energy; headache; flu like symptoms; swollen legs; water retention; she is going into depression; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number Unknown) via an unspecified route of administration on 26Mar2021 at single dose for Covid-19 immunization. The patient's medical history included diabetic. The patient's concomitant medications were not reported. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) on 05Mar2021 via an unspecified route of administration as single dose for Covid-19 immunization and experienced bone chilling chills, body ache, lingering cough, no energy, headache, flu like symptoms, swollen leg and water retention. Beginning after the first dose and been going on for over 3 months she reported symptoms of bone chilling chills, body aches, lingering cough, no energy, headache, flu like symptoms, swollen legs, and water retention. Caller was followed by nephrology and endocrinology. Caller saw nephrologist who reported everything was fine from her end. Caller was concerned for a heart condition and saw a cardiologist on Monday because of the swollen legs and water retention who did a chest CT, echocardiogram, and EKG all of which they said were fine. Caller recently saw a "lungs doctor" who prescribed albuterol and Spiriva for her lingering cough. Caller seeking information on how long these symptoms were going to last. Caller reported she has an appointment tomorrow with her primary care doctor. Caller stated that was not a common way to live she was going into depression and spoke of "hanging myself on a tree". She has seen several doctors already and there has been a lot of possibilities and so further cannot pinpoint anything. Caller confirmed she gave this information previously. She was just wondering how long will it take to subside or was this going to be an ongoing thing. She states she can't live like that. There were side effects that she has and she was curious how long was it go to be until they subside. As a treatment for cough patient was prescribed albuterol and Spiriva. The patient underwent lab tests and procedures which included Chest CT, Echocardiogram and (Electrocardiogram) EKG and the result of all was fine. The outcome of event was not recovered at the time of reporting.  Information about lot/batch number is requested follow-up attempts are needed.   Amendment: This follow-up report is being submitted to amend previously reported information: event "she is going into depression and spoke of "hanging myself on a tree"  was added and coded to "Suicidal ideation; seriousness was upgraded to Medically Significant.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Suicidal ideation
Clinical narrative: she is going into depression and spoke of "hanging myself on a tree"; bone chilling chills; whole body aches; lingering cough; no energy; headache; flu like symptoms; swollen legs; water retention; she is going into depression; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number Unknown) via an unspecified route of administration on 26Mar2021 at single dose for Covid-19 immunization. The patient's medical history included diabetic. The patient's concomitant medications were not reported. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) on 05Mar2021 via an unspecified route of administration as single dose for Covid-19 immunization and experienced bone chilling chills, body ache, lingering cough, no energy, headache, flu like symptoms, swollen leg and water retention. Beginning after the first dose and been going on for over 3 months she reported symptoms of bone chilling chills, body aches, lingering cough, no energy, headache, flu like symptoms, swollen legs, and water retention. Caller was followed by nephrology and endocrinology. Caller saw nephrologist who reported everything was fine from her end. Caller was concerned for a heart condition and saw a cardiologist on Monday because of the swollen legs and water retention who did a chest CT, echocardiogram, and EKG all of which they said were fine. Caller recently saw a "lungs doctor" who prescribed albuterol and Spiriva for her lingering cough. Caller seeking information on how long these symptoms were going to last. Caller reported she has an appointment tomorrow with her primary care doctor. Caller stated that was not a common way to live she was going into depression and spoke of "hanging myself on a tree". She has seen several doctors already and there has been a lot of possibilities and so further cannot pinpoint anything. Caller confirmed she gave this information previously. She was just wondering how long will it take to subside or was this going to be an ongoing thing. She states she can't live like that. There were side effects that she has and she was curious how long was it go to be until they subside. As a treatment for cough patient was prescribed albuterol and Spiriva. The patient underwent lab tests and procedures which included Chest CT, Echocardiogram and (Electrocardiogram) EKG and the result of all was fine. The outcome of event was not recovered at the time of reporting.  Information about lot/batch number is requested follow-up attempts are needed.   Amendment: This follow-up report is being submitted to amend previously reported information: event "she is going into depression and spoke of "hanging myself on a tree"  was added and coded to "Suicidal ideation; seriousness was upgraded to Medically Significant.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urinary tract infection
Clinical narrative: after the 1st dose she had a rectal rash that was "very bad." /then got the same rash on her inner elbow of the injection arm; taking an antibiotic for a recurrent urinary tract infection; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration on 05Jun2021 (Batch/Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Two weeks after the first one, the patient had a rectum rash really bad. She also had a rash on her inner elbow on the same arm the vaccine was given on. The patient was taking an antibiotic for a recurrent urinary tract infection on an unspecified date. She stated that she was currently taking an antibiotic for a recurrent urinary tract infection she had and wanted to make sure it was okay to get the vaccine as scheduled this weekend while taking her antibiotic. She just wanted to know if these were side effects. She asked that do they have to eat certain foods or eliminate prescriptions after getting the vaccine. The outcome of the events was unknown.  Information on batch/lot numbers are available. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Clostridium difficile colitis, Clostridium difficile infection
Clinical narrative: Caller states she may have had diarrhea while receiving the vaccine, but has since been diagnosed with C-diff./colitis difficile; C-difficile; This is a spontaneous report form a contactable consumer. A unspecified age elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown), via unspecified route of administration on an unknown date in Mar2021 (reported as Early march) as 1st dose, single for COVID-19 immunization. The patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown), via unspecified route of administration on an unknown date (6 weeks after first dose), as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient complained of Clostridium difficile after receiving the Pfizer Covid vaccine. Caller stated that she may have had diarrhea while receiving the vaccine. On an unknown date, she had been diagnosed with clostridium difficile. She was treated with multiple unspecified antibiotics for months and was currently being treated with Vancomycin 2 times daily. The patient stated that she approached multiple physician visits, including gastroenterology in an effort to determine if Celiac disease, or irritable bowel syndrome are the cause of the C-diff. Caller was very upset that she took the Pfizer covid vaccine, although she reported that she was aware of someone else going through the same experience after taking the Moderna Vaccine. The patient wanted to know if heard of side effect colitis difficile (C-diff) from vaccine because she had the C-diff now but not before the first dose. The patient wanted to know if this could be a side effect. She was asking because her friends sister had the same experience not from the Pfizer Covid vaccine but from Moderna. Consumer stated, she was trying to find out if some condition that she had developed after getting the Covid vaccine could be possible or it was just a co-incidence. The outcome of the event was unknown.  Information on batch/Lot number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Electrocardiogram, Fatigue, Headache
Clinical narrative: Strong beating heart, irregular heartbeat; Palpitations and lightheadedness.; Palpitations and lightheadedness.; Body chills; Throbbing headache; Fatigue; Borderline left atrial enlargement; This is a spontaneous report from a contactable consumer.A 33-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 10Jun2021 at 12:15 (33 years age at the vaccination) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The other medications patient received within 2 weeks of vaccination included Tylenol after the second shot. Patient had no known allergies. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. It was reported that the patient was overall a healthy athlete. On 16Jun2021 at 08:00 AM, after second shot, after body chills, throbbing headache and fatigue passed (2-3 days), the patient started to have strong beating heart, irregular heartbeat, palpitations and lightheadedness. Patient went to urgent care on his 5th day of having this with a very irregular heartbeat, so they took him in right away. All tests clear but EKG/ECG shown borderline left atrial enlargement. Still watching and keeping record today. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No therapeutic measures were taken for the events. The patient recovered from body chills, throbbing headache and fatigue in Jun2021, and patient had not yet recovered from rest of the events.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Left atrial enlargement, Palpitations
Clinical narrative: Strong beating heart, irregular heartbeat; Palpitations and lightheadedness.; Palpitations and lightheadedness.; Body chills; Throbbing headache; Fatigue; Borderline left atrial enlargement; This is a spontaneous report from a contactable consumer.A 33-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 10Jun2021 at 12:15 (33 years age at the vaccination) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The other medications patient received within 2 weeks of vaccination included Tylenol after the second shot. Patient had no known allergies. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. It was reported that the patient was overall a healthy athlete. On 16Jun2021 at 08:00 AM, after second shot, after body chills, throbbing headache and fatigue passed (2-3 days), the patient started to have strong beating heart, irregular heartbeat, palpitations and lightheadedness. Patient went to urgent care on his 5th day of having this with a very irregular heartbeat, so they took him in right away. All tests clear but EKG/ECG shown borderline left atrial enlargement. Still watching and keeping record today. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No therapeutic measures were taken for the events. The patient recovered from body chills, throbbing headache and fatigue in Jun2021, and patient had not yet recovered from rest of the events.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Severe bleeding during period.She has been on her period for 14 days; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Not reported), via an unspecified route of administration, in right arm (at the age of 26-year-old) on 08Jun2021 at 10:00 as dose number unknown, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of the vaccination. On 09Jun2021, the patient experienced severe bleeding during period. She had been on her period for 14 days straight till the day of reporting (which is abnormally long for her) and the bleeding was abnormally heavy, where no matter how many tampons and pads she wore (sometimes both) it will seep through. This had been consistent for the last 14 days. The patient did not receive treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was not recovered.   Information regarding the Lot/Batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-1 test positive, Vaccination site erythema
Clinical narrative: large raised red area at the injection site that grew larger and went away after about a week; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 34-years-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0185, Expiration date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 09:45 (Age at Vaccination 34 year) as dose, single for covid-19 immunisation. Medical history included Hashimoto disease from an unknown date and unknown if ongoing, patient was covid-19 positive before vaccination. patient received first dose of bnt162b2 (BNT162B2, Lot number: EW0170) via unspecified route administered in Left arm on 20Apr2021 09 :15 AM as dose 1 single for covid-19 immunisation and patient experience No reaction on previous exposure to vaccine. Concomitant medication included spironolactone (ALDACTONE A) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported. Since the vaccination, has the patient had not been tested for COVID-19. patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced large raised red area at the injection site that grew larger and went away after about a week on May2021. adverse event resulted in patient visit to Physician office. The patient underwent lab tests and procedures which included sars-cov-1 test positive before vaccination on an unspecified date. The outcome was not recovered.  Additional information has been requested
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Back pain, Dizziness, Dyspnoea
Clinical narrative: Extreme vaginal bleeding; Some difficulty in breathing; Prolonged period; Migraines; Dizziness; Nausea; Lower back pain; Abdominal pain; Weakness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 21-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 10May2021 (age at vaccination was 21 years) as 2nd dose, single for COVID-19 immunization. Medical history included known allergies to Sulfas. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 19Apr2021 (age at vaccination was 21 years) as 1st dose, single for COVID-19 immunization. The patient previously took amoxicillin and experienced known allergies. The facility where the most recent COVID-19 vaccine was administered was Other. 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 been tested for COVID-19. The patient underwent lab tests which included Nasal Swab: negative on 21May2021. On 28May2021, patient experienced extreme vaginal bleeding/ prolonged period/ migraines, dizziness, nausea, lower back pain, abdominal pain, some difficulty in breathing and weakness. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The device date was reported as 23Jun2021. The case was reported as non-serious. The outcome of events was not resolved.  Information on lot/batch number was available.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Migraine, Nausea, SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Extreme vaginal bleeding; Some difficulty in breathing; Prolonged period; Migraines; Dizziness; Nausea; Lower back pain; Abdominal pain; Weakness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 21-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 10May2021 (age at vaccination was 21 years) as 2nd dose, single for COVID-19 immunization. Medical history included known allergies to Sulfas. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 19Apr2021 (age at vaccination was 21 years) as 1st dose, single for COVID-19 immunization. The patient previously took amoxicillin and experienced known allergies. The facility where the most recent COVID-19 vaccine was administered was Other. 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 been tested for COVID-19. The patient underwent lab tests which included Nasal Swab: negative on 21May2021. On 28May2021, patient experienced extreme vaginal bleeding/ prolonged period/ migraines, dizziness, nausea, lower back pain, abdominal pain, some difficulty in breathing and weakness. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The device date was reported as 23Jun2021. The case was reported as non-serious. The outcome of events was not resolved.  Information on lot/batch number was available.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hyperhidrosis, Hypersensitivity, Hypotension
Clinical narrative: Severe allergic reaction; Sweating; Nauseous; Felt like she was going to pass out; Blood pressure was low; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot number and Expiry date: Unknown), via an unspecified route of administration, administered in Arm on 18May2021 about 09:00  (at the age of 22-year-old) as dose 1, single for Covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not received any treatment and diagnosed with covid 19 and had not been tested for COVID-19 Since the vaccination. She received her first dose on 18May2021. On the same day she had a severe allergic reaction and the paramedics were called and she was taken by ambulance to the hospital. She was fine now. Shortly after getting the vaccine, within 5 minutes (on 18May2021) of getting the shot, she was still in the waiting period, she began profusely sweating. She was nauseous and felt like she was going to pass out. They called the paramedics. When the paramedics came her blood pressure was low, like 55/48. Her blood pressure had dropped dramatically. The ambulance came and took the hospital, Emergency Room.The patient underwent lab tests and procedures which included blood pressure measurement: 55/48. Treatment included they monitored her with an EKG for several hours. She was given an IV to make sure stay hydrated. She was released mid-afternoon that day after being monitored for a number of hours. She was released after she began to stabilize and blood pressure normalized. The outcome of events severe allergic reaction and blood pressure was low was recovering and other events was unknown.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Severe allergic reaction; Sweating; Nauseous; Felt like she was going to pass out; Blood pressure was low; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot number and Expiry date: Unknown), via an unspecified route of administration, administered in Arm on 18May2021 about 09:00  (at the age of 22-year-old) as dose 1, single for Covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not received any treatment and diagnosed with covid 19 and had not been tested for COVID-19 Since the vaccination. She received her first dose on 18May2021. On the same day she had a severe allergic reaction and the paramedics were called and she was taken by ambulance to the hospital. She was fine now. Shortly after getting the vaccine, within 5 minutes (on 18May2021) of getting the shot, she was still in the waiting period, she began profusely sweating. She was nauseous and felt like she was going to pass out. They called the paramedics. When the paramedics came her blood pressure was low, like 55/48. Her blood pressure had dropped dramatically. The ambulance came and took the hospital, Emergency Room.The patient underwent lab tests and procedures which included blood pressure measurement: 55/48. Treatment included they monitored her with an EKG for several hours. She was given an IV to make sure stay hydrated. She was released mid-afternoon that day after being monitored for a number of hours. She was released after she began to stabilize and blood pressure normalized. The outcome of events severe allergic reaction and blood pressure was low was recovering and other events was unknown.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Tension headache, Tinnitus, Visual impairment
Clinical narrative: Horrible tinnitus with very bad neck pain; Horrible tinnitus with very bad neck pain; Tension headaches; vision issues; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6202 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 07Mar2021 at 14:45 hours as dose 2, single (at the age of 47-years-old) for covid-19 immunization. Medical history included known allergy to penicillin from an unknown date and unknown if ongoing and had no other medical history. Patient previously received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ELG9266 and Expiration date was not reported), via an unspecified route of administration, in left arm on 14Feb2021 at 14:00 hours as dose 1, single (at the age of 47-years-old) for covid-19 immunization. Patient did not receive any other medications the patient received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient had not been tested for COVID-19, since the vaccination. On 21Mar2021 at 19:00 hours, patient experienced horrible tinnitus with very bad neck pain, tension headaches and vision issues. Patient had doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit for the events. Patient had various ongoing treatments for all the events. The events were reported as non-serious as per the reporter. The outcome of all the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid after being fully vaccinated; Tested positive for covid after being fully vaccinated; This is a spontaneous report from a non-contactable physician via a sales representative. This Physician reported for male (Patient) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose and patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via unspecified route of administration on an unspecified date as single dose both for COVID-19 immunization. The caller stated she was a Pfizer representative, and she was having lunch in a doctor's office and she overheard one of the doctors discussing another doctor in her territory that had COVID-19 on 21Jun2021 and stated this doctor has been vaccinated. Confirmed he was fully vaccinated with the Pfizer vaccine, and she just heard this today. Caller stated the patient was not sick and had not many symptoms, but she felt like she needed to call it as she was fully vaccinated. Stated it was something that she overhead, she has not spoken with the patient about it, she was not at work. She was out for ten or fourteen days. Caller added, he was probably diagnosed on Monday of this week, because he claimed he got it at (see field) the week before. Caller did not think patient has been to the hospital or anything because (withheld) said the patient was not very sick. Caller stated he told Dr. (withheld) he had a positive COVID-19 test, and that he had both Pfizer vaccines. Caller stated (withheld) asked her if she thought the test could be negative or false, or something, and she stated she had no idea. Caller asked was there any information about a booster dose, a booster shot, or anything yet. Outcome for the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report, A meaningful medical assessment is not possible. Case will be reviewed once additional information is available
Sex: F
Vaccine: COVID19
Symptoms: Bipolar I disorder, Blood test, SARS-CoV-2 test, Suicidal ideation
Clinical narrative: manic depression; Suicidal to the full extent / Suicidal overpowering thoughts; This is a spontaneous report from a contactable consumer.  A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in Right arm on 18Apr2021 (Batch/Lot Number: EN6207) as for covid-19 immunisation and experienced no reaction. Medical history included depression and anxiety. Concomitant medications included trazodone taken for an unspecified indication, start and stop date were not reported; venlafaxine taken for an unspecified indication, start and stop date were not reported; bupropion taken for an unspecified indication, start and stop date were not reported. After receiving the second dose of the Pfizer vaccine, on 14May2021 patient experienced manic depression, I've never been so low. Suicidal to the full extent, pushed everyone away, tried to break up with boyfriend because I felt worthless. The depression was consuming, constant and I was a shell of a person for weeks. Let me just say again how intense the Suicidal overpowering thoughts were. It was terrifying, I was absolutely not even close to myself and the only thing I did different in my life was get the second dose. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, patient test for COVID-19. On 31May2021, the patient underwent lab tests and procedures which included blood test and sars-cov-2 test result as negative. The outcome of events was recovering.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, Bedridden
Clinical narrative: severe arthritis pain in her feet; could not get out of bed for 5 days.; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation; apixaban (ELIQUIS; Batch/Lot number was not reported), via an unspecified route of administration from 01Oct2017 at unspecified dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient stated that after receiving the Pfizer COVID-19 vaccine, she experienced severe arthritis pain in her feet on an unspecified date. She noted that she could not get out of bed for 5 days. No further information provided. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective
Clinical narrative: it was reported that patient experienced: Covid-Pneumonia; it was reported that patient experienced: Covid-Pneumonia; This is a spontaneous report received from a contactable consumer (patient) via Drug Safety. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection), dose 2 via an unspecified route of administration on 07May2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. Medical history included ongoing multiple sclerosis (concurrent condition). Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for Covid-19 Immunization. Concomitant medication included Ocrelizumab (OCREVUS) taken for an unspecified indication, start and stop date were not reported. The patient experienced Covid-pneumonia on 31May2021. The outcome of event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the limited information in the case report, A possible causal relationship between Covid-19 pneumonia and suspect drug BNT162B2 cannot be excluded..
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product preparation issue
Clinical narrative: Pfizer Covid 19 vaccine- giving to kids today and diluted it with 1.2mL instead of 1.8mL of diluent/4 kids got a stronger dose than they should have; Pfizer Covid 19 vaccine- giving to kids today and diluted it with 1.2mL instead of 1.8mL of diluent/4 kids got a stronger dose than they should have; This is a spontaneous report from a contactable other hcp. A 13-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8734; Expiration Date: 31Jul2021, NDC number: 59267-1000-02), via an unspecified route of administration, administered in left deltoid on 23Jun2021 13:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation (reported as she is over 12). Medical history reported as none. The patient's concomitant medications were not reported. No history of previous immunization with the Pfizer vaccine considered as suspect. Caller was not aware if the patient had any Prior Vaccinations (within 4 weeks) and adverse events following prior vaccinations. On 23Jun2021 13:00, Pfizer COVID-19 vaccine- giving to kids today and diluted it with 1.2ml instead of 1.8ml of diluent/4 kids got a stronger dose than they should have. Caller states that they were administering Pfizer COVID vaccines. They diluted it with 1.2mL instead of 1.8mL. It was reported that "caller states they were doing Moderna injections in one room and Pfizer in another room and it gets confusing. Caller will call the parents and let them know about this. Seriousness Criteria: Caller states this is serious. Verbatim event relatedness: Pfizer COVID Vaccine: Vaccine was diluted with 1.2mL instead of 1.8mL was administered - Related." Adverse events did not require Emergency Room and Physician Office visit.   Information about batch/Lot number has been requested.  Follow up (23Jun2021): This is a follow-up report combining information from duplicate reports [2021769141] and [2021781997]. The current and all subsequent information will be reported under manufacturer report number [2021769141]. New information included that: Patient's age and gender were added, Batch/lot number, expiration date, anatomical location were added, vaccine start and stop date, events onset were updated, events were upgraded with seriousness criteria of medically significant, medical history was updated to none, reporter causality updated in narrative,  Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspected vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-2021766740 same reporter/SD/AE, different patients