chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Patient had a heart attack; This is a spontaneous report from a contactable consumer. This consumer reported for a 66 year old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration in the left arm on 29Mar2021 at 09:00 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included thyroid. The patient did not had any allergies. The patient's concomitant medications included levothyroxine sodium (THYROXINE) from an unknown date. The patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 04Apr2021 at 08:00, the patient had a heart attack (hospitalized (Emergency room/department or urgent care), medically significant) for which treatment was ongoing and scheduled angiogram. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, SARS-CoV-2 test
Clinical narrative: The patient appears to have developed acute myopericarditis within 3 days of receiving the vaccine.; This is a spontaneous report from a contactable physician. A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were not provided), via an unspecified route of administration on 31Mar2021 (at the age of 22-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive any other medications within 2 weeks of vaccination. Patient has not COVID, prior vaccination. On 03Apr2021, the patient appears to have developed acute myopericarditis within 3 days of receiving the vaccine (adverse event result in Emergency room/department or urgent care). Patient received treatment with acetylsalicylic acid (ASPIRIN) and colchicine. Patient has been tested for COVID in 2021, post vaccination, Test type: Nasal Swab and result was negative. The outcome of the event was recovering.  Additional information on lot/batch number has been requested.; Sender's Comments: Based on the known vaccine safety profile the causal association between the reported event patient appears to have developed acute myopericarditis within 3 days of receiving the vaccine and the usage of the vaccine BNT162B2 is unlikely but cannot be completely excluded because of strong temporal association between the event and the suspected vaccine. The case will be assessed once the new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Fall, Syncope
Clinical narrative: fainted; collapsed; This is a spontaneous report from a contactable other health care professional. A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EP6955), via intramuscular route of administration in deltoid on 04Apr2021 at 02:00 PM at single dose for COVID-19 immunisation. Medical history included allergy to penicillin (PCN), congestive heart failure (CHF), diabetes mellitus (DM) and had chronic/long-standing health conditions (pacemaker). Concomitant medication was not reported. Patient previously received first single dose of bnt162b2 (Lot number: EP6955, Pfizer Covid Vaccine) via intramuscular on 14Mar2021 on deltoid for Covid-19 immunization. Patient fainted while shopping after receiving second dose of vaccine. Patient was fine for initial 15 mins but shortly after collapsed. Patient had BP Of 120/70 an unknown glucose level. Patient was conscious coherent the entire time. On 04Apr2021, patient underwent lab test included blood pressure (BP) with result 102/70. Adverse events were resulted in emergency room or emergency department visit. The outcome of events was unknown.  Follow-up attempts are needed; Information related to batch/lot number could be requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: tested positive about 4 days later/got sick; This is a spontaneous report received from a non-contactable consumer (Patient) via medical information team. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and lot number: unknown) via an unspecified route of administration on 10Jan2021 as a single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient tested positive about 4 days later, on 18Jan2021. patient stated she "got sick" on an unspecified date in 2021. she said she received a "monoclonal antibody transfusion on 22Jan2021". Outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Bell's palsy, Extraocular muscle paresis, Hypoaesthesia, Hypoaesthesia eye
Clinical narrative: Weakness of Right Eye; Numbness in right eye; Feels tugging in the back of her head and symptoms around right eye; Weakness in arms and legs; Feels tugging in the back of her head and symptoms around right eye; Neuropathic Symptoms on Right Side of Face; Numbness on Right Side of Mouth; she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her Bell's Palsy, and the corner of mouth started to have numbness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported) via an unspecified route of administration on 29Mar2021 (at the age of 41-year-old) as single dose for covid-19 immunization. Medical history included facial paralysis from 1998 to an unknown date, Bells palsy at age 18 , ongoing temporomandibular joint syndrome , asthma exercise, depression, pain, hypoaesthesia, Numbness in face in the past (June 2020 tele-visit with neurologist), fatigue, headache, anxiety. Concomitant medications included gabapentin (GABAPENTIN) taken for neurological symptom, hydroxyzine (HYDROXYZINE) taken for anxiety. The patient experienced she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her bell's palsy, and the corner of mouth started to have numbness on 01Mar2021 with, neuropathic symptoms on right side of face on 01Apr2021 with, numbness on right side of mouth on 01Apr2021, weakness of right eye numbness in right eye, feels tugging in the back of her head and symptoms around right eye, weakness in arms and legs, feels tugging in the back of her head and symptoms around right eye. Caller states basically she had Bell's Palsy years ago and was left with cranial nerve damage. She stated she noticed after the first Pfizer vaccine, that in that area of the face that she had Bell's Palsy, she started having neuropathic symptoms. and stated that it started thursday. States it has been there for a couple of days and she still has a little bit of neuropathic symptoms but not as great as when the onset began. The outcome of the events was recovering.   Information about batch/lot number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Muscular weakness, Neuropathy peripheral
Clinical narrative: Weakness of Right Eye; Numbness in right eye; Feels tugging in the back of her head and symptoms around right eye; Weakness in arms and legs; Feels tugging in the back of her head and symptoms around right eye; Neuropathic Symptoms on Right Side of Face; Numbness on Right Side of Mouth; she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her Bell's Palsy, and the corner of mouth started to have numbness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported) via an unspecified route of administration on 29Mar2021 (at the age of 41-year-old) as single dose for covid-19 immunization. Medical history included facial paralysis from 1998 to an unknown date, Bells palsy at age 18 , ongoing temporomandibular joint syndrome , asthma exercise, depression, pain, hypoaesthesia, Numbness in face in the past (June 2020 tele-visit with neurologist), fatigue, headache, anxiety. Concomitant medications included gabapentin (GABAPENTIN) taken for neurological symptom, hydroxyzine (HYDROXYZINE) taken for anxiety. The patient experienced she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her bell's palsy, and the corner of mouth started to have numbness on 01Mar2021 with, neuropathic symptoms on right side of face on 01Apr2021 with, numbness on right side of mouth on 01Apr2021, weakness of right eye numbness in right eye, feels tugging in the back of her head and symptoms around right eye, weakness in arms and legs, feels tugging in the back of her head and symptoms around right eye. Caller states basically she had Bell's Palsy years ago and was left with cranial nerve damage. She stated she noticed after the first Pfizer vaccine, that in that area of the face that she had Bell's Palsy, she started having neuropathic symptoms. and stated that it started thursday. States it has been there for a couple of days and she still has a little bit of neuropathic symptoms but not as great as when the onset began. The outcome of the events was recovering.   Information about batch/lot number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; This is a spontaneous report from a non-contactable consumer (Patient).  A 63-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), dose 1st via an unspecified route of administration, administered in Arm Left on 01Apr2021 08:00 as single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported.  On 01Apr2021 11:15, the patient experienced Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack. The patient had other medications in two weeks of vaccination. Patient did not took any treatment for adverse event. Patient did not had covid prior vaccination and not tested for covid post vaccination. She did not have any Known allergies and had other medical history.    No follow up needed. No further information is excepted.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pancreatitis, Pyrexia
Clinical narrative: Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; This is a spontaneous report from a non-contactable consumer (Patient).  A 63-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), dose 1st via an unspecified route of administration, administered in Arm Left on 01Apr2021 08:00 as single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported.  On 01Apr2021 11:15, the patient experienced Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack. The patient had other medications in two weeks of vaccination. Patient did not took any treatment for adverse event. Patient did not had covid prior vaccination and not tested for covid post vaccination. She did not have any Known allergies and had other medical history.    No follow up needed. No further information is excepted.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: my stool have mucus and red streaks of blood; On April 4 around 1 or 2pm I have diarrhea; This is a spontaneous report from a contactable consumer (patient). A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Mar2021 13:30 as single dose for covid-19 immunisation. Medical history included Heart palpitations, anxiety, high cholesterol. Concomitant medication included omeprazole. On 04Apr2021 01:15PM, the patient experienced diarrhea, It seems to be getting worse and stool had mucus and red streaks of blood. Patient tried to see a doctor at urgent care. It was unknow that patient received treatment for the adverse event or not., since the vaccination patient did not tested for COVID-19. The outcome of events was not recovered.   Information on lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Asthenia, Body temperature, Diplopia, Fatigue
Clinical narrative: Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6208, expiration date: 30Jun2021) via unspecified route of administration in right arm on 25Mar2021 15:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Patient medical history included Guillain Barre syndrome on Feb2017 and asthma on unspecified date. Concomitant medication included ongoing IVIG treatment, unspecified (one infusion every four weeks) for Guillain Barre syndrome. The patient previously received first dose of bnt162b2 (lot number EN6201) on 04Mar2021 at the age of 56-years-old for covid-19 Immunization, and experienced sore arm.  On 25Mar2021, after the second dose of the vaccine, the patient felt really lousy. The patient was fatigued on unspecified date in Mar2021. On 29Mar2021, patient had lower abdominal pain and low grade fever. The left side has been the side that has been impacted by Guillain Barre syndrome CID and that was the side that was affected after the vaccine. On 28Mar2021, the patient experienced weakness; was too weak to care for herself and she and her husband decided to go into the hospital. The patient was admitted on 28Mar2021 by neurologist (for the event weakness) and she stayed 2 nights and then came home 30Mar2021. The patient had been tired and weak since discharge from the hospital. The patient was on a monthly course of IVIG but the round she got in the hospital was exactly 2 weeks in-between her scheduled monthly treatments. Complete fatigue and weakness were still ongoing. The patient also experienced double vision on unspecified date in Mar2021 which was ongoing, but this was something that starts flaring up with her condition. The patient's low grade fever experienced on 29Mar2021 lasted for 3-4 days. The patient has gone backwards in her Guillain Barre syndrome since she had the vaccine, her opinion is that this was a set back she is not sorry she got the vaccine and is grateful for it. Events resulted in emergency room visit and Physician's office visit. Outcome of the events (weakness, fatigue and double vision) was not recovered. Event (Lower abdominal pain) was recovering; event (low grade fever) was recovered on unspecified date (lasted 3-4 days); while outcome of event (felt lousy) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6208, expiration date: 30Jun2021) via unspecified route of administration in right arm on 25Mar2021 15:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Patient medical history included Guillain Barre syndrome on Feb2017 and asthma on unspecified date. Concomitant medication included ongoing IVIG treatment, unspecified (one infusion every four weeks) for Guillain Barre syndrome. The patient previously received first dose of bnt162b2 (lot number EN6201) on 04Mar2021 at the age of 56-years-old for covid-19 Immunization, and experienced sore arm.  On 25Mar2021, after the second dose of the vaccine, the patient felt really lousy. The patient was fatigued on unspecified date in Mar2021. On 29Mar2021, patient had lower abdominal pain and low grade fever. The left side has been the side that has been impacted by Guillain Barre syndrome CID and that was the side that was affected after the vaccine. On 28Mar2021, the patient experienced weakness; was too weak to care for herself and she and her husband decided to go into the hospital. The patient was admitted on 28Mar2021 by neurologist (for the event weakness) and she stayed 2 nights and then came home 30Mar2021. The patient had been tired and weak since discharge from the hospital. The patient was on a monthly course of IVIG but the round she got in the hospital was exactly 2 weeks in-between her scheduled monthly treatments. Complete fatigue and weakness were still ongoing. The patient also experienced double vision on unspecified date in Mar2021 which was ongoing, but this was something that starts flaring up with her condition. The patient's low grade fever experienced on 29Mar2021 lasted for 3-4 days. The patient has gone backwards in her Guillain Barre syndrome since she had the vaccine, her opinion is that this was a set back she is not sorry she got the vaccine and is grateful for it. Events resulted in emergency room visit and Physician's office visit. Outcome of the events (weakness, fatigue and double vision) was not recovered. Event (Lower abdominal pain) was recovering; event (low grade fever) was recovered on unspecified date (lasted 3-4 days); while outcome of event (felt lousy) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram normal, Condition aggravated, Dysphagia
Clinical narrative: Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6208, expiration date: 30Jun2021) via unspecified route of administration in right arm on 25Mar2021 15:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Patient medical history included Guillain Barre syndrome on Feb2017 and asthma on unspecified date. Concomitant medication included ongoing IVIG treatment, unspecified (one infusion every four weeks) for Guillain Barre syndrome. The patient previously received first dose of bnt162b2 (lot number EN6201) on 04Mar2021 at the age of 56-years-old for covid-19 Immunization, and experienced sore arm.  On 25Mar2021, after the second dose of the vaccine, the patient felt really lousy. The patient was fatigued on unspecified date in Mar2021. On 29Mar2021, patient had lower abdominal pain and low grade fever. The left side has been the side that has been impacted by Guillain Barre syndrome CID and that was the side that was affected after the vaccine. On 28Mar2021, the patient experienced weakness; was too weak to care for herself and she and her husband decided to go into the hospital. The patient was admitted on 28Mar2021 by neurologist (for the event weakness) and she stayed 2 nights and then came home 30Mar2021. The patient had been tired and weak since discharge from the hospital. The patient was on a monthly course of IVIG but the round she got in the hospital was exactly 2 weeks in-between her scheduled monthly treatments. Complete fatigue and weakness were still ongoing. The patient also experienced double vision on unspecified date in Mar2021 which was ongoing, but this was something that starts flaring up with her condition. The patient's low grade fever experienced on 29Mar2021 lasted for 3-4 days. The patient has gone backwards in her Guillain Barre syndrome since she had the vaccine, her opinion is that this was a set back she is not sorry she got the vaccine and is grateful for it. Events resulted in emergency room visit and Physician's office visit. Outcome of the events (weakness, fatigue and double vision) was not recovered. Event (Lower abdominal pain) was recovering; event (low grade fever) was recovered on unspecified date (lasted 3-4 days); while outcome of event (felt lousy) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Guillain-Barre syndrome, Hemiparesis, Hypoaesthesia, Pain in extremity
Clinical narrative: Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6208, expiration date: 30Jun2021) via unspecified route of administration in right arm on 25Mar2021 15:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Patient medical history included Guillain Barre syndrome on Feb2017 and asthma on unspecified date. Concomitant medication included ongoing IVIG treatment, unspecified (one infusion every four weeks) for Guillain Barre syndrome. The patient previously received first dose of bnt162b2 (lot number EN6201) on 04Mar2021 at the age of 56-years-old for covid-19 Immunization, and experienced sore arm.  On 25Mar2021, after the second dose of the vaccine, the patient felt really lousy. The patient was fatigued on unspecified date in Mar2021. On 29Mar2021, patient had lower abdominal pain and low grade fever. The left side has been the side that has been impacted by Guillain Barre syndrome CID and that was the side that was affected after the vaccine. On 28Mar2021, the patient experienced weakness; was too weak to care for herself and she and her husband decided to go into the hospital. The patient was admitted on 28Mar2021 by neurologist (for the event weakness) and she stayed 2 nights and then came home 30Mar2021. The patient had been tired and weak since discharge from the hospital. The patient was on a monthly course of IVIG but the round she got in the hospital was exactly 2 weeks in-between her scheduled monthly treatments. Complete fatigue and weakness were still ongoing. The patient also experienced double vision on unspecified date in Mar2021 which was ongoing, but this was something that starts flaring up with her condition. The patient's low grade fever experienced on 29Mar2021 lasted for 3-4 days. The patient has gone backwards in her Guillain Barre syndrome since she had the vaccine, her opinion is that this was a set back she is not sorry she got the vaccine and is grateful for it. Events resulted in emergency room visit and Physician's office visit. Outcome of the events (weakness, fatigue and double vision) was not recovered. Event (Lower abdominal pain) was recovering; event (low grade fever) was recovered on unspecified date (lasted 3-4 days); while outcome of event (felt lousy) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Swallow study
Clinical narrative: Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6208, expiration date: 30Jun2021) via unspecified route of administration in right arm on 25Mar2021 15:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Patient medical history included Guillain Barre syndrome on Feb2017 and asthma on unspecified date. Concomitant medication included ongoing IVIG treatment, unspecified (one infusion every four weeks) for Guillain Barre syndrome. The patient previously received first dose of bnt162b2 (lot number EN6201) on 04Mar2021 at the age of 56-years-old for covid-19 Immunization, and experienced sore arm.  On 25Mar2021, after the second dose of the vaccine, the patient felt really lousy. The patient was fatigued on unspecified date in Mar2021. On 29Mar2021, patient had lower abdominal pain and low grade fever. The left side has been the side that has been impacted by Guillain Barre syndrome CID and that was the side that was affected after the vaccine. On 28Mar2021, the patient experienced weakness; was too weak to care for herself and she and her husband decided to go into the hospital. The patient was admitted on 28Mar2021 by neurologist (for the event weakness) and she stayed 2 nights and then came home 30Mar2021. The patient had been tired and weak since discharge from the hospital. The patient was on a monthly course of IVIG but the round she got in the hospital was exactly 2 weeks in-between her scheduled monthly treatments. Complete fatigue and weakness were still ongoing. The patient also experienced double vision on unspecified date in Mar2021 which was ongoing, but this was something that starts flaring up with her condition. The patient's low grade fever experienced on 29Mar2021 lasted for 3-4 days. The patient has gone backwards in her Guillain Barre syndrome since she had the vaccine, her opinion is that this was a set back she is not sorry she got the vaccine and is grateful for it. Events resulted in emergency room visit and Physician's office visit. Outcome of the events (weakness, fatigue and double vision) was not recovered. Event (Lower abdominal pain) was recovering; event (low grade fever) was recovered on unspecified date (lasted 3-4 days); while outcome of event (felt lousy) was unknown.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Choking, Dizziness, Dyspnoea, Insomnia
Clinical narrative: feel like choking; I am almost dead in the kitchen, because I can't breathe; stuck my food everything; dizzy; Muscle pain; had for 2 night 3 days a lot of saliva; saliva comes from my gland; she spit saliva with in combination with mucus; felt almost dead; Water come see through saliva, I cannot sleep for 2 or 3 days; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8734 and expiration date was not reported) via unspecified route on left arm on 30Mar2021 (at the age of 57-years-old) at single dose for covid-19 immunisation. Patient did not take any concomitant medications. Patient had no medical history. No investigation assessment were done. Reportedly, patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6205 and expiration date was not reported) on 06Mar2021 (at the age of 57-years-old). Patient reported that she got very bad experiences in the first. She was almost dead in the kitchen, because she could not breathe, stuck her food everything, she go somewhere, she was choking almost she feel dead. Patient got very bad experience from the Pfizer vaccine, so the experience was, In her first vaccine one day after she was feeling like choking, breathing air, shortness of breath and choking I can't eat anything if all food I eat they go different ways. This is her first shot muscle pain, this was normal okay and this choking she could not eat food very well because the food goes different ways in my trachea, this is her first experience in her first shot. Patient reported that her second shot was terrible, she got same symptoms and she got muscle pain she got dizzy, then most hard time again she had for 2 night 3 days a lot of saliva, saliva comes from my gland. For saliva, she think you wanted to see water come see through saliva, I cannot sleep for 2 or 3 days. Patient had same thing almost choking, she had expel, expel choking in the day and when she lay down the other night. The spit saliva started Friday, she spit saliva with in combination with mucus, mucus and saliva. Patient wanted to report that, because you know what happen, all the information stated was false. They don't, they didn't stated everything. Patient wanted to report that she was in a hospital. The outcome of the events was unknown.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Salivary hypersecretion, Secretion discharge
Clinical narrative: feel like choking; I am almost dead in the kitchen, because I can't breathe; stuck my food everything; dizzy; Muscle pain; had for 2 night 3 days a lot of saliva; saliva comes from my gland; she spit saliva with in combination with mucus; felt almost dead; Water come see through saliva, I cannot sleep for 2 or 3 days; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8734 and expiration date was not reported) via unspecified route on left arm on 30Mar2021 (at the age of 57-years-old) at single dose for covid-19 immunisation. Patient did not take any concomitant medications. Patient had no medical history. No investigation assessment were done. Reportedly, patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6205 and expiration date was not reported) on 06Mar2021 (at the age of 57-years-old). Patient reported that she got very bad experiences in the first. She was almost dead in the kitchen, because she could not breathe, stuck her food everything, she go somewhere, she was choking almost she feel dead. Patient got very bad experience from the Pfizer vaccine, so the experience was, In her first vaccine one day after she was feeling like choking, breathing air, shortness of breath and choking I can't eat anything if all food I eat they go different ways. This is her first shot muscle pain, this was normal okay and this choking she could not eat food very well because the food goes different ways in my trachea, this is her first experience in her first shot. Patient reported that her second shot was terrible, she got same symptoms and she got muscle pain she got dizzy, then most hard time again she had for 2 night 3 days a lot of saliva, saliva comes from my gland. For saliva, she think you wanted to see water come see through saliva, I cannot sleep for 2 or 3 days. Patient had same thing almost choking, she had expel, expel choking in the day and when she lay down the other night. The spit saliva started Friday, she spit saliva with in combination with mucus, mucus and saliva. Patient wanted to report that, because you know what happen, all the information stated was false. They don't, they didn't stated everything. Patient wanted to report that she was in a hospital. The outcome of the events was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism, SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood Clots; Pulmonary Embolisms; DVT (Deep vein thrombosis); This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ENG207), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:00 (at the age of 47years) as single dose for Covid-19 immunization. The patient received the dose 1 of BNT162B2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 08:30 (Batch/Lot Number: ENG203) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included essential tremor, insulin resistance, and anxiety; all from an unknown date and unknown if ongoing. Concomitant medications included propranolol, metformin, bupropion, and citalopram; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood clots, pulmonary embolisms, and a DVT (deep vein thrombosis) on 04Apr2021 (11:00AM). The patient was hospitalized due to the events for 4 days. The patient was treated with Heparin and Eliquis. The patient was tested for Covid-19 post vaccination via Nasal Swab on 03Apr2021 with Negative result. The outcome of events was recovering. The adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Multiple pulmonary embolism in both lungs; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 10:00 (Batch/Lot Number: Ew6202) as single dose, for covid-19 immunisation at a pharmacy/drug store. Medical history included diabetes. The patient has no known allergies and no COVID prior to vaccination. The patient has other medications in two weeks but no other vaccine in four weeks. The patient experienced multiple pulmonary embolism in both lungs on 28Feb2021 08:00. The patient was hospitalized for multiple pulmonary embolism in both lungs for 3 days. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit, and considered life threatening illness (immediate risk of death from the event). The patient was treated with blood thinners. The patient had the second dose of BNT162B2 on 18Mar2021 at 11:00 am in the left arm. The patient was tested for Covid post vaccination via nasal swab (rapid) on 10Apr2021 which was negative. The outcome of the event was not recovered.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Pulmonary thrombosis, Scan with contrast abnormal
Clinical narrative: Multiple pulmonary embolism in both lungs; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 10:00 (Batch/Lot Number: Ew6202) as single dose, for covid-19 immunisation at a pharmacy/drug store. Medical history included diabetes. The patient has no known allergies and no COVID prior to vaccination. The patient has other medications in two weeks but no other vaccine in four weeks. The patient experienced multiple pulmonary embolism in both lungs on 28Feb2021 08:00. The patient was hospitalized for multiple pulmonary embolism in both lungs for 3 days. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit, and considered life threatening illness (immediate risk of death from the event). The patient was treated with blood thinners. The patient had the second dose of BNT162B2 on 18Mar2021 at 11:00 am in the left arm. The patient was tested for Covid post vaccination via nasal swab (rapid) on 10Apr2021 which was negative. The outcome of the event was not recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thrombin, Cerebrovascular accident, Computerised tomogram head
Clinical narrative: Suffered a stroke; blood clots in the brain; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 04Jan2021 14:00 at a single dose for COVID-19 immunisation. Medical history included heart valve replacement, thyroid issues and headache. Concomitant medications included medications in the last two weeks (unspecified). The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization. On 24Feb2021 12:00 PM, the patient suffered a stroke - blood clots in the brain. Had brain scans earlier in the year for headaches but nothing found. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The patient was hospitalized for the events for 7 days. Therapeutic measures were taken as a result of the events which included surgery to break and remove the clot. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. The facility where the vaccine was administered was in a Public Health Clinic facility. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was recovered on an unspecified date.   Information about lot/batch number has been requested.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary Embolism in right lung; This is a spontaneous report from a contactable consumer (patient). A 92-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration, administered in right arm on 16Feb2021 at 12:45 PM at the age of 92-years-old as single dose for COVID-19 immunization. Facility type vaccine was reported as Other. The patient had no other vaccine in four weeks. The patient's medical history included known allergies to penicillin and sulfa drugs. Concomitant medications included fluoxetine, cyanocobalamin (B12-VITAMIN), and fish oil (OMEGA 3); all taken for unspecified indications, start and stop dates were not reported (reported as other medications in two weeks). The patient previously took potassium iodate and experienced allergies. The patient previously received the first dose of BNT162B2 in the right arm on 26Jan2021 at 12:45 PM (lot number: EL9261) at the age of 92-years-old for COVID-19 immunization. The patient experienced pulmonary embolism in right lung on 07Mar2021 at 09:00 AM. The event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for pulmonary embolism in right lung for 2 days in 2021. The patient received treatment for the event which included heparin. The patient had no COVID prior the vaccination and was not tested for COVID post vaccination. The outcome of the event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: suddenly passed away; This is a spontaneous report from a contactable healthcare professional reporting on behalf of friend's husband. A 43-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr20201, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient suddenly passed away on 11Apr2021. It was unknown if an autopsy was performed or not. The patient passed away at home and he was otherwise healthy. The reporter stated there was not a way to know if it was related to the vaccine as of right now.  Information on lot number/batch number has been requested.; Sender's Comments: Limited information precludes a medically meaningful assessment of the case. A possible contributory role of the suspect product BNT162B2 to the development of event Sudden death cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: suddenly passed away
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Appendicitis, Appendix disorder, Back pain
Clinical narrative: appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer.   A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store.  Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days.  The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination.  Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.