chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Fatigue, Feeling of body temperature change, Hypertension, Myalgia
Clinical narrative: loss of hearing; Right arm sore; Tinnitus; Fatigue; Muscle aches; Hot and cold; High blood pressure.; This is a spontaneous report from a non-contactable consumer (patient). This female adult patient received bnt162b2 dose 2 via unspecified route of administration in right arm in Mar2021 02:00 PM (Lot number unknown) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. 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. The patient previously received bnt162b2 dose 1 via unspecified route of administration in right arm in Feb2021 02:00 PM (Lot number unknown) at single dose for COVID-19 immunization and experienced right arm sore. The patient received the second dose in Mar2021 and experienced loss of hearing, right arm sore, tinnitus, fatigue, muscle aches, hot and cold, high blood pressure on 08Mar2021 17:00. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received Injection of steroid for ear as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event events was recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: loss of hearing; Right arm sore; Tinnitus; Fatigue; Muscle aches; Hot and cold; High blood pressure.; This is a spontaneous report from a non-contactable consumer (patient). This female adult patient received bnt162b2 dose 2 via unspecified route of administration in right arm in Mar2021 02:00 PM (Lot number unknown) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. 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. The patient previously received bnt162b2 dose 1 via unspecified route of administration in right arm in Feb2021 02:00 PM (Lot number unknown) at single dose for COVID-19 immunization and experienced right arm sore. The patient received the second dose in Mar2021 and experienced loss of hearing, right arm sore, tinnitus, fatigue, muscle aches, hot and cold, high blood pressure on 08Mar2021 17:00. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received Injection of steroid for ear as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event events was recovered.   Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; Not feeling very well; This is a spontaneous report received from a contactable consumer or other non hcp and from a Pfizer Sponsored Program. A 52-years-old male patient received bnt162b2, Solution for injection (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 17:45 (Batch/Lot Number: EP7534) as single dose for COVID-19 immunization. Medical history included supraventricular tachycardia from Oct2019 and ongoing. The patient's concomitant medications were not re-ported. The patient was tested positive for covid-19 on 30Mar2021 and not feeling very well in Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on 30Mar2021. He was given a steroid and an albuterol inhaler. Therapeutic measures were taken as a result of, covid-19 and not feeling very well. Patient got his first dose of the COVID Vaccine on 16Mar2021 and a few days later started not feeling very well and it has continued since then. He went to the doctor today and tested positive for COVID 19. His second dose is scheduled for 06Apr2021. He asks if a positive test has any effect on if he should follow through with the second shot or should he reschedule. Physician said he does not have a PCP right now and he went to Urgent Care. Within a couple of days patient did not feel well. It was probably the 17th or 18th. His symptoms are lingering. He tested positive today. He was taking over the counter stuff until today, he got prescribed a steroid for his symptoms. How he feels depends heavily on if he was taking medicine or not. He does not have product information for the over the counter medications taken available. No further details provided. There was not a date on the card, not an expiration date, but there was a date for his second vaccination. His employer gave him a letter that said he was eligible for it. He had avoided getting COVID for a year. Patient received his first COVID vaccine two weeks ago, went to urgent care today and has tested positive for COVID and would like to know if he should still take the second COVID vaccine or wait until his symptoms are gone. Transferred to public service due to having side effects and getting COVID. Due to their being a few callers ahead asked him if he would mind waiting in the waiting que and the next available medical professional from public service will be happy to answer your question. The outcome of the event was not recovered for malaise and unknown for other events.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: cerebral palsy in my left hand and it seems to be a better; left hand started hurting; couldn't move fingers; my whole hand swelled a little bit; hand had like a slight fever to it, it was warm; chills my whole hand like it's going down; little jerks in my hands; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 (at the age of 55years) as single dose for Covid-19 immunization. Medical history included Chronic obstructive pulmonary disease (COPD), heterotaxia (Situs inversus), ankylosing spondylitis, back problem, and cerebral palsy; all from an unknown date and unknown if ongoing. Concomitant medications included diazepam, methocarbamol, meloxicam, salbutamol (ALBUTEROL), and unspecified muscle relaxant; all taken for an unspecified indication, start and stop date were not reported. The patient reported side effects that has official after taking the COVID shot (confirmed as Pfizer COVID Vaccine). The patient stated "I've got cerebral palsy in my left hand and it seems to be a better connection in my left hand, I can now, it's easier for me to pick up small objects and I used to have problems doing that. It is like, I am messenger pain is eating my nerve endings. But here's what happened, 2 days after taking the shot around 26th, I took the shot on 24thMarch, 2021; I took Diazepam, Meloxicam and muscle relaxer (captured as unspecified medication) for back problem. I don't even know if it had anything to do with it, might be just been all the shot, but methocarbamol too. I took those 3 drugs, 2 hours after that, my whole hand, my whole left hand, just my left hand started hurting (further clarification unknown hence captured as suspect conservatively). In my left-hand kind of after feeling and I couldn't move my fingers as well. And afterwards it was in March, it started hurting, my whole hand swelled a little bit. It had like a slight fever to it, it was warm, and it swelled up just slightly not up here, nothing big. I still can't put in my ring, but it was slightly bigger than what it is today, and this hurt. It felt like, I've chills my whole hand like it's going down. So, I work it out, I stretched it, that helped the pain so I could work with them during my fingers stopped working it out. And then afterwards I found out I could, my hands were moving better, it works better. Before I've like little jerks in my hands, you know my hand wouldn't do what I wanted it to do. What I wanted to do more, I can press button, I can pick up smaller objects. It's not 100 percent better, it's not as good as my right hand which had no cerebral palsy in it but it's a lot better than it was. So, I just wanted to report that." The outcome of events was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Tremor
Clinical narrative: cerebral palsy in my left hand and it seems to be a better; left hand started hurting; couldn't move fingers; my whole hand swelled a little bit; hand had like a slight fever to it, it was warm; chills my whole hand like it's going down; little jerks in my hands; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 (at the age of 55years) as single dose for Covid-19 immunization. Medical history included Chronic obstructive pulmonary disease (COPD), heterotaxia (Situs inversus), ankylosing spondylitis, back problem, and cerebral palsy; all from an unknown date and unknown if ongoing. Concomitant medications included diazepam, methocarbamol, meloxicam, salbutamol (ALBUTEROL), and unspecified muscle relaxant; all taken for an unspecified indication, start and stop date were not reported. The patient reported side effects that has official after taking the COVID shot (confirmed as Pfizer COVID Vaccine). The patient stated "I've got cerebral palsy in my left hand and it seems to be a better connection in my left hand, I can now, it's easier for me to pick up small objects and I used to have problems doing that. It is like, I am messenger pain is eating my nerve endings. But here's what happened, 2 days after taking the shot around 26th, I took the shot on 24thMarch, 2021; I took Diazepam, Meloxicam and muscle relaxer (captured as unspecified medication) for back problem. I don't even know if it had anything to do with it, might be just been all the shot, but methocarbamol too. I took those 3 drugs, 2 hours after that, my whole hand, my whole left hand, just my left hand started hurting (further clarification unknown hence captured as suspect conservatively). In my left-hand kind of after feeling and I couldn't move my fingers as well. And afterwards it was in March, it started hurting, my whole hand swelled a little bit. It had like a slight fever to it, it was warm, and it swelled up just slightly not up here, nothing big. I still can't put in my ring, but it was slightly bigger than what it is today, and this hurt. It felt like, I've chills my whole hand like it's going down. So, I work it out, I stretched it, that helped the pain so I could work with them during my fingers stopped working it out. And then afterwards I found out I could, my hands were moving better, it works better. Before I've like little jerks in my hands, you know my hand wouldn't do what I wanted it to do. What I wanted to do more, I can press button, I can pick up smaller objects. It's not 100 percent better, it's not as good as my right hand which had no cerebral palsy in it but it's a lot better than it was. So, I just wanted to report that." The outcome of events was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Blacked out/Was out for over 2 minutes; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8733, on 30Mar2021 15:45 at single dose in left arm for Covid-19 immunization. Medical history was none. Concomitant medications were none. The patient previously received barium and had Allergies. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was Blacked out on 30Mar2021 15:45 and was taken to hospital by ambulance. Was out for over 2.minutes. No other reaction. Duration of hospitalization was 1 day. The event resulted in Emergency Room Visit and Physician Office Visit. No treatment was received. The outcome of the event was resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Disorientation, Dizziness, Facial paralysis, Hypertension
Clinical narrative: My mouth on the right side droops slightly; feel a wired dizziness that got worse; Blood pressure was high; I was disoriented  and I could not move my arms or legs; they were not able to understand my speech; I could not move my arms or legs; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: ER2613) in right arm on 26Mar2021 08:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Graves Disease (in remission), papillary necrosis of kidney, Raynaud's, fibromyalgia, breast cancer survivor. Allergies to medications, food, or other products: Morphine, Sulfa, Aspirin, Ibuprofen, Bactrim, Escitalopram. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ascorbic acid, cobalt sulfate, copper sulfate, ergocalciferol, ferrous fumarate, magnesium sulfate, manganese sulfate, nicotinamide, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, vitamin b12 nos, zinc gluconate (MULTIVITAMIN (16)), gabapentin, tizanidine, paracetamol (TYLENOL). Patient experienced: Less than 10 minutes in the waiting area (reported as 26Mar2021 08:15 AM), began to feel a wired dizziness that got worse and she was able to signal a nurse who was attending to another lady having a reaction in the same seating area. Blood pressure was high, she was disoriented and she could not move her arms or legs. According to the doctor and nurse, they were not able to understand her speech. Her mouth on the right side droops slightly. Patient was admitted on 26Mar2021 and discharged from hospital on 28Mar2021. Events resulted in Emergency room/department or urgent care, Hospitalization. Treatment included testing, IV. Covid test post vaccination on 26Mar2021 (nasal swab) was negative. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Motor dysfunction, SARS-CoV-2 test, Speech disorder
Clinical narrative: My mouth on the right side droops slightly; feel a wired dizziness that got worse; Blood pressure was high; I was disoriented  and I could not move my arms or legs; they were not able to understand my speech; I could not move my arms or legs; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: ER2613) in right arm on 26Mar2021 08:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Graves Disease (in remission), papillary necrosis of kidney, Raynaud's, fibromyalgia, breast cancer survivor. Allergies to medications, food, or other products: Morphine, Sulfa, Aspirin, Ibuprofen, Bactrim, Escitalopram. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ascorbic acid, cobalt sulfate, copper sulfate, ergocalciferol, ferrous fumarate, magnesium sulfate, manganese sulfate, nicotinamide, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, vitamin b12 nos, zinc gluconate (MULTIVITAMIN (16)), gabapentin, tizanidine, paracetamol (TYLENOL). Patient experienced: Less than 10 minutes in the waiting area (reported as 26Mar2021 08:15 AM), began to feel a wired dizziness that got worse and she was able to signal a nurse who was attending to another lady having a reaction in the same seating area. Blood pressure was high, she was disoriented and she could not move her arms or legs. According to the doctor and nurse, they were not able to understand her speech. Her mouth on the right side droops slightly. Patient was admitted on 26Mar2021 and discharged from hospital on 28Mar2021. Events resulted in Emergency room/department or urgent care, Hospitalization. Treatment included testing, IV. Covid test post vaccination on 26Mar2021 (nasal swab) was negative. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Lymphadenopathy, Pain, Pain in extremity, Pain of skin
Clinical narrative: her pain is worse constantly and she can hardly use the opposite arm; even to touch the skin is extremely painful; her cubicular lymph node was swollen; the area between her neck and armpit has swelled up more and more; pain in between neck and armpit; pain goes into back; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 2 parenteral (reported as "injection") at the age of 66-years-old on 19Mar2021 (Batch/Lot number was not reported) as single dose in Arm Left for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2), dose 1 on an unspecified date for COVID-19 immunization. The patient received the first vaccine with no problem. She received the second vaccine on Friday 19Mar2021 and the next day, 20Mar2021 it felt like her cubicular lymph node was swollen. Every day since then, the area between her neck and armpit has swelled up more and more. Her pain is worse constantly and she can hardly use the opposite arm and even to touch the skin is extremely painful. This is on the opposite side from where she received the shot. The event "area between neck and armpit swelled up" started 20Mar2021 and is ongoing. It increases constantly and it is almost disabling it is in between medically significant and disabling. It has worsened. The event "pain in between neck and armpit" started the past Friday (Mar2021) and is ongoing. It is medically significant but almost disabling as she cannot use her right arm. This has worsened. The event "pain goes into back" started 2 days ago and is ongoing. This is medically significant and has worsened. Treatment was received for the events. The doctor gave her Toradol injection intramuscular and it did not effect anything and she has also taken Tramadol and Flexeril, a muscle relaxer, which did not effect anything. Her doctor has never seen anything like the symptoms she is experiencing. She had an X-ray done but she does not have the results yet as it was done yesterday (29Mar2021). The outcome of the events "her cubicular lymph node was swollen" and "even to touch the skin is extremely painful" was unknown while for the rest of the events was not recovered.  Relatedness to COVID 19 vaccine: area between neck and armpit swelled up, pain in between neck and armpit, pain goes into back - Related.  Information on the batch/lot number was requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, X-ray
Clinical narrative: her pain is worse constantly and she can hardly use the opposite arm; even to touch the skin is extremely painful; her cubicular lymph node was swollen; the area between her neck and armpit has swelled up more and more; pain in between neck and armpit; pain goes into back; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 2 parenteral (reported as "injection") at the age of 66-years-old on 19Mar2021 (Batch/Lot number was not reported) as single dose in Arm Left for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2), dose 1 on an unspecified date for COVID-19 immunization. The patient received the first vaccine with no problem. She received the second vaccine on Friday 19Mar2021 and the next day, 20Mar2021 it felt like her cubicular lymph node was swollen. Every day since then, the area between her neck and armpit has swelled up more and more. Her pain is worse constantly and she can hardly use the opposite arm and even to touch the skin is extremely painful. This is on the opposite side from where she received the shot. The event "area between neck and armpit swelled up" started 20Mar2021 and is ongoing. It increases constantly and it is almost disabling it is in between medically significant and disabling. It has worsened. The event "pain in between neck and armpit" started the past Friday (Mar2021) and is ongoing. It is medically significant but almost disabling as she cannot use her right arm. This has worsened. The event "pain goes into back" started 2 days ago and is ongoing. This is medically significant and has worsened. Treatment was received for the events. The doctor gave her Toradol injection intramuscular and it did not effect anything and she has also taken Tramadol and Flexeril, a muscle relaxer, which did not effect anything. Her doctor has never seen anything like the symptoms she is experiencing. She had an X-ray done but she does not have the results yet as it was done yesterday (29Mar2021). The outcome of the events "her cubicular lymph node was swollen" and "even to touch the skin is extremely painful" was unknown while for the rest of the events was not recovered.  Relatedness to COVID 19 vaccine: area between neck and armpit swelled up, pain in between neck and armpit, pain goes into back - Related.  Information on the batch/lot number was requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis aggressive symptoms; This is spontaneous report from a contactable consumer or other non hcp. A 23-year-old female patient (cousin, not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 01:00 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient recently got diagnosed with rheumatoid arthritis. This has been something that has been through reporter dad's side of the family. Reporter's aunt has had it since she was a kid. The patient who was just diagnosed started having aggressive symptoms a month after her second dose of the covid vaccine shot. The outcome was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fatigue, Headache, Myalgia, Rash
Clinical narrative: fatigue; felt like she was going to have a stroke; hives; two seizures; rash from head to toe; wrap around headache; sore muscles; This is a spontaneous report from a contactable other healthcare professional (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6208), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history included seizure, high blood pressure, and atrial fibrillation with rapid ventricular response on 03Feb2021, all ongoing. The patient's concomitant medications included metoprolol tartrate (LOPRESSOR) taken for blood pressure measurement, lisinopril taken for an unspecified indication, valproate semisodium (DEPAKOTE) taken for seizure from 2017 to an unspecified stop date, and hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for an unspecified indication. The patient experienced two seizures on 27Mar2021. Patient felt like she was going to have a stroke on an unspecified date. The patient experienced hives on 27Mar2021, fatigue on an unspecified date, rash from head to toe on 27Mar2021, wrap around headache on 26Mar2021, and sore muscles on 26Mar2021. The outcome of the events wrap around headache and sore muscles was recovered on 28Mar2021, for hives and rash from head to toe was recovering, and the outcome of the rest of the events was unknown. Events relatedness was reported as related.; Sender's Comments: Other than a close temporal association, there was no other evidence or argument in support to causality for BNT162B2 in the serious events, Seizure and Cerebrovascular accident. Seizure was consistent with underlying medical condition, still on treatment with VALPROATE SEMISODIUM. Chronic hypertension may have increased the risk of vascular accident, despite the poly-medication with different type of antihypertensive agents. 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: Seizure, Urticaria
Clinical narrative: fatigue; felt like she was going to have a stroke; hives; two seizures; rash from head to toe; wrap around headache; sore muscles; This is a spontaneous report from a contactable other healthcare professional (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6208), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history included seizure, high blood pressure, and atrial fibrillation with rapid ventricular response on 03Feb2021, all ongoing. The patient's concomitant medications included metoprolol tartrate (LOPRESSOR) taken for blood pressure measurement, lisinopril taken for an unspecified indication, valproate semisodium (DEPAKOTE) taken for seizure from 2017 to an unspecified stop date, and hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for an unspecified indication. The patient experienced two seizures on 27Mar2021. Patient felt like she was going to have a stroke on an unspecified date. The patient experienced hives on 27Mar2021, fatigue on an unspecified date, rash from head to toe on 27Mar2021, wrap around headache on 26Mar2021, and sore muscles on 26Mar2021. The outcome of the events wrap around headache and sore muscles was recovered on 28Mar2021, for hives and rash from head to toe was recovering, and the outcome of the rest of the events was unknown. Events relatedness was reported as related.; Sender's Comments: Other than a close temporal association, there was no other evidence or argument in support to causality for BNT162B2 in the serious events, Seizure and Cerebrovascular accident. Seizure was consistent with underlying medical condition, still on treatment with VALPROATE SEMISODIUM. Chronic hypertension may have increased the risk of vascular accident, despite the poly-medication with different type of antihypertensive agents. 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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid after first dose of the vaccine./ The caller's friend tested positive 2 weeks after getting the vaccine.; Tested positive for covid after first dose of the vaccine./ The caller's friend tested positive 2 weeks after getting the vaccine.; This is a spontaneous report received from a contactable consumer. Report 2 of 2.This consumer reported for a 59-year-old female patient (friend) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number, expiration date: unknown) via an unspecified route of administration on 15Mar2021 at a single dose for COVID-19 immunization. Medical history and concomitant medication were unknown. On 29Mar2021, the patient tested positive two weeks after getting first dose of the vaccine. The patient received the vaccine on the same day as the caller on 15Mar2021. State filed in. The Product Complaint as the patient tested positive 2 weeks after getting the vaccine. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Suicidal ideation
Clinical narrative: suicidal thoughts; depression; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (age at vaccination was 41 years) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: ER2613) in left arm on 17Mar2021 17: 00 at a single dose for COVID-19 immunization. Vaccine Facility type was hospital. Medical history was none. Allergies to medications, food, or other products was no. Patient was not pregnant at the time of vaccination. Concomitant medications included celecoxib (CELAXA) and rosuvastatin calcium (CRESTOR). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that 2 days post shot on 19Mar2021 09:00, she began to have suicidal thoughts. She did suffer from depression, but she was not suicidal and have never been treated for this level of depression before. 2 1/2 weeks later her mood has improved. She did not harm herself. Events were considered non-serious. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 8 days after first dose; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that, the patient received first dose and 8 days later, she tested positive for COVID 19. The reporter wanted to know the appropriate place to report this. She wanted to know if it could be reported on the Safety website. She will have patient do it. She just wanted to make sure it was appropriate place. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a non-contactable consumer or other non-health care professional via Medical Information Team. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date in Dec2020 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: e10140) via an unspecified route of administration on an unspecified date in Jan2021 both as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter mentioned that, on an unspecified date, the three patients at the skilled nursing facility tested positive for Covid after receiving both doses. Reporter also mentioned that all three patients received the same lot number. Reporter wanted to know if there is any information on that specific lot number and any problems with that lot number. Reporter stated that he reported. Reporter also wanted to know if there is any data on the efficacy of the vaccine in the older population. On an unspecified date, patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361018 Same reporter/drug, different patient/event.;US-PFIZER INC-2021363888 Same reporter/drug, different patient/event.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a non-contactable consumer. This report refers to three patients.  The patient of an unknown age and gender received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Lot Number: E10140 expiry date not reported) via an unspecified route of administration on an unknown date in Jan2021, at a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Lot Number: E10140 expiry date not reported) via an unspecified route of administration on an unknown date in Dec2021, at a single dose for Covid-19 immunization. On an unknown date, all the three patients were tested positive for covid-19 vaccine. The outcome of the events of Covid-19 and drug ineffective was unknown.  No follow-up attempts possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021363887 Same reporter/drug, different patient/event.;US-PFIZER INC-2021361018 Same reporter/drug, different patient/event.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Headache, Pain in extremity
Clinical narrative: Hallucinations; Headache; sharp pain through arm come and go and arm sore; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 04Mar2021 10:00 (Batch/Lot Number: EN6200; Expiration Date: Jun2021) as SINGLE DOSE for COVID-19 immunization at the doctor'ss office. Medical history included arthritis and was diabetic. Concomitant medications were not reported. It was reported that right after the first dose probably first, second, or third night in Mar2021 the patient had hallucinations. The patient also had headaches and sharp pain through arm/arm sore a couple of days after the first dose (probably started the next day or even the same day) which come and go. The patient recovered from the events in Mar2021 (a week or week in a half maybe two weeks before getting second dose).    Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Nasal oedema, Parosmia
Clinical narrative: acute sense of smell; nose is swelling; This is a spontaneous report received from a contactable 84-year-old female nurse (patient). An 84-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Feb2021 (Lot Number: EN6206) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing asthma from 2019 and ongoing. Concomitant medications included albuterol [salbutamol] taken for wheezing from an unspecified start date and ongoing; beclometasone dipropionate (QVAR, lot number: ASR72A, expiration date: Sep2021) taken for shortness of breath from Aug2019 and ongoing; oxygen using this for sleep from 2012 and ongoing.  The patient experienced acute sense of smell and nose is swelling on 25Feb2021. Also on an unspecified date, the patient stated she has shrunk from 5 feet 5 1/4 inches to now 5 feet 2 inches. The events parosmia and nasal edema was assessed as medically significant by the reporter. Outcome of the event body height decreased was unknown while outcome of the remaining events was recovered on 25Feb2021.   Follow up attempts are needed. Further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: Odynophagia, Swelling
Clinical narrative: neck was swollen; painful to swallow; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient got the 1st dose on 19Mar2021 and a few days after her neck was swollen and painful to swallow. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Constipation, Pain in extremity
Clinical narrative: Abdominal Pain; Leg aching; constipation; This is a spontaneous report from a non-contactable consumer (patient reported for herself) via a specialty pharmacy in the. A 69-year-old female patient received BNT162B2 (COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization and naltrexone (VIVITROL, Formulation: Solution for injection, Lot number: 2020-3020T) intramuscularly from 25Dec2020 and ongoing at 380 mg monthly for opioid dependence. This patient's medical history included opioid dependence. Concomitant medications were not reported. On an unspecified date, the patient experienced abdominal pain, leg pain and constipation. It was reported that, "on December 2020, naltrexone for extended release VIVITROL for injection 380 mg intramuscular-glut monthly was initiated, for the treatment of opioid dependence. On an unspecified date, the patient received a COVID vaccine dose. On an unspecified date, after the COVID vaccine was administered, the patient experienced abdominal pain, leg aching and constipation, the symptoms were considered as mild. The status of VIVITROL was ongoing". Treatment for the events was not reported. Outcome of the events was not resolved. Causality was assessed as unknown to VIVITROL. No further details were provided at the time of this report.  No follow-up attempts needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Blood test, Computerised tomogram, Constipation, Dry mouth
Clinical narrative: constipation continued and worsened 4 days after second Pfizer shot; tinnitus; dry mouth; the top of my tongue has turned white; a serious taste distortion in my mouth; This is a spontaneous report from a contactable consumer (the patient). A 53-year-old male patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 23Mar2021 at age of 53-year-old at single dose for COVID-19 immunisation. Medical history included autoimmune autonomic disorder, Sjogren's disease, Crohn's (in remission 3 decades), COVID, known allergies: Ototoxic reaction to clarithromycin (BIAXIN), also skin rash to levofloxacin (LEVAQUIN) and ciprofloxacin (CIPRO). Concomitant medication included doxycycline taken for an unspecified indication from an unspecified date. No other vaccine was used in four weeks. No COVID tested post vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264) via an unspecified route of administration in right arm on 01Mar2021 06:45 PM at age of 53-year-old for COVID-19 immunisation. Approximately 4 days after the first COVID shot (05Mar2021), the patient developed constipation. This constipation continued and worsened 4 days after his second Pfizer shot (27Mar2021). On 23Mar2021, the patient developed tinnitus and a very dry mouth. Coincident with the dry mouth, the top of his tongue had turned white and he have developed a serious taste distortion in his mouth. The constipation initially partially responded to laxatives between the first and second vaccinations, but starting 4 after the second vaccination, the laxatives have stopped working. The events were resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient underwent lab tests and procedures which included abdominal CT, blood tests, hearing test, all with unknown results. The outcome of the events was not recovered.  Information about the Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361319 same patient/drug, different events after first dose
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder, Tinnitus, Tongue discolouration
Clinical narrative: constipation continued and worsened 4 days after second Pfizer shot; tinnitus; dry mouth; the top of my tongue has turned white; a serious taste distortion in my mouth; This is a spontaneous report from a contactable consumer (the patient). A 53-year-old male patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 23Mar2021 at age of 53-year-old at single dose for COVID-19 immunisation. Medical history included autoimmune autonomic disorder, Sjogren's disease, Crohn's (in remission 3 decades), COVID, known allergies: Ototoxic reaction to clarithromycin (BIAXIN), also skin rash to levofloxacin (LEVAQUIN) and ciprofloxacin (CIPRO). Concomitant medication included doxycycline taken for an unspecified indication from an unspecified date. No other vaccine was used in four weeks. No COVID tested post vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264) via an unspecified route of administration in right arm on 01Mar2021 06:45 PM at age of 53-year-old for COVID-19 immunisation. Approximately 4 days after the first COVID shot (05Mar2021), the patient developed constipation. This constipation continued and worsened 4 days after his second Pfizer shot (27Mar2021). On 23Mar2021, the patient developed tinnitus and a very dry mouth. Coincident with the dry mouth, the top of his tongue had turned white and he have developed a serious taste distortion in his mouth. The constipation initially partially responded to laxatives between the first and second vaccinations, but starting 4 after the second vaccination, the laxatives have stopped working. The events were resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient underwent lab tests and procedures which included abdominal CT, blood tests, hearing test, all with unknown results. The outcome of the events was not recovered.  Information about the Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361319 same patient/drug, different events after first dose
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he also had COVID-19/tested positive for Covid-19; he also had COVID-19/tested positive for Covid-19; This is a spontaneous report received from a contactable consumer (patient). A 43-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine but he also had COVID-19 and didn't know it. The day that he got his shot, that night he was really sick. He said he felt really ill and had a loss of taste. He saw a doctor, and it was determined that he tested positive for COVID-19. He stated that he more than likely already had it but didn't find out till after he'd already gotten the shot and was sick. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Loss of personal independence in daily activities, Pain, Peripheral swelling, Pyrexia
Clinical narrative: body pains; swelling from the side of the vaccine down to the armpit; a fever at 101.2F; cannot go to work; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated she experienced body pains and swelling from the side of the vaccine down to the armpit and it is swollen and very painful. She's having a fever at 101.2F and a lot of pain and cannot go to work. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.