chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Disturbance in attention, Feeling abnormal, Illness
Clinical narrative: 12 hours after receiving my 3rd vaccine I became violently ill.; I vomited continuously for an hour; Chills; Shaking; Body aches; Chest pain; I now have brain fog; I now have brain fog and am unable to concentrate at work; I had to take 11/1 off of work because I have been extremely sick; Booster; This is a spontaneous report from a contactable healthcare professional, the patient. A 46-year-old non-pregnant female patient received a third (booster) dose of BNT162b2 (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on 29Oct2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included sertraline hydrochloride (ZOLOFT) and ibuprofen (MANUFACTURER UNKNOWN); both from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took two doses of COVID-19 Vaccine of unknown manufacturer for COVID-19 immunisation, so primary Immunization series was complete. It was reported that the patient had experienced the side effects with dose one and two also on unknown dates. On 30Oct2021 at 01:30, the patient became violently ill (also reported 12 hours after receiving third vaccine), vomited continuously for an hour, she had chills, shaking, body aches, chest pain. At the time of report, the patient was having brain fog, was unable to concentrate at work and had to take off of work on 01Nov2021, because she had been extremely sick. The side effects the patient experienced were tenfold than what she had experienced with her dose first and second vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of events. The clinical outcome of the events became violently ill, vomited continuously for an hour, chills, shaking, body aches, chest pain was resolving, while that of brain fog, unable to concentrate at work and had to take off on 01Nov2021 because she had been extremely sick was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Malaise, Pain, Tremor, Vomiting
Clinical narrative: 12 hours after receiving my 3rd vaccine I became violently ill.; I vomited continuously for an hour; Chills; Shaking; Body aches; Chest pain; I now have brain fog; I now have brain fog and am unable to concentrate at work; I had to take 11/1 off of work because I have been extremely sick; Booster; This is a spontaneous report from a contactable healthcare professional, the patient. A 46-year-old non-pregnant female patient received a third (booster) dose of BNT162b2 (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on 29Oct2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included sertraline hydrochloride (ZOLOFT) and ibuprofen (MANUFACTURER UNKNOWN); both from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took two doses of COVID-19 Vaccine of unknown manufacturer for COVID-19 immunisation, so primary Immunization series was complete. It was reported that the patient had experienced the side effects with dose one and two also on unknown dates. On 30Oct2021 at 01:30, the patient became violently ill (also reported 12 hours after receiving third vaccine), vomited continuously for an hour, she had chills, shaking, body aches, chest pain. At the time of report, the patient was having brain fog, was unable to concentrate at work and had to take off of work on 01Nov2021, because she had been extremely sick. The side effects the patient experienced were tenfold than what she had experienced with her dose first and second vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of events. The clinical outcome of the events became violently ill, vomited continuously for an hour, chills, shaking, body aches, chest pain was resolving, while that of brain fog, unable to concentrate at work and had to take off on 01Nov2021 because she had been extremely sick was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: PNC13
Symptoms: Amnesia, Burning sensation, Lip swelling, Pharyngeal swelling, Throat irritation
Clinical narrative: Swelling of her lips; Swelling of her throat; She had burning in her throat; Lost her memory for the next hour and a half,  so it was not a great experience; This is a spontaneous report from a contactable consumer (son of patient).   A female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as unknown single dose for immunisation.  The patient's medical history and concomitant medications was not reported. The had the Prevnar 13 vaccine and about 10 hours after the vaccine she experienced, swelling of her lips and her throat and we went to the hospital and she had some burning in her and they gave her like pills of Benadryl (Treatment) and 'not clear', she had burning in her throat, lost her memory for the next hour and a half, so it was not a great experience. Everything turned out to be okay and start to work post that everything was okay.  Treatment was received for burning in her throat included Benadryl. The outcome of events was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
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 contactable pharmacist (patient) reporting for herself. A 37-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Mar2021, as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, the patient had drug ineffective and tested positive for covid-19 and was wondering how long she had to wait after that diagnosis to get her booster dose. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test which showed positive results (she has since tested positive for Covid). Outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events Drug ineffective, Covid-19 and the administration of the vaccine cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation, Lactic acidosis, Off label use, Renal injury
Clinical narrative: became ill causing severe kidney injury; became ill causing severe kidney injury; Lactic acidosis; Off-label use; Booster; This is a spontaneous report from a contactable Nurse (patient).   A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 3 intramuscular, administered in Arm Left on 29Oct2021 (at the age of 61-years-old), as single dose for covid-19 immunization. The patient had received the first dose of the same vaccine on 25Dec2020, at the Arm Left via Intramuscular route at the age of 61-years-old and the second dose on 29Jan2021, at the Arm right via Intramuscular route at the age of 61-years-old. Medical history included diabetes mellitus, hypertension and thyroid disorder. On 29Oct2021 the patient became ill causing severe kidney injury resulting in a three days hospitalization and a near miss from going on dialysis therapy, with outcome of recovering. The patient was not pregnant. The patient received an aggressive fluid rehydration with sodium bicarbonate due to lactic acidosis. No Covid prior vaccination and the patient was not tested for covid post vaccination.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Renal injury, illness and Lactic acidosis and BNT162B2.  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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Anaphylactic reaction; could not breathe; This is a spontaneous report from a contactable physician reported for 60-year-old female patient (cousin) received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via intramuscular route on an unspecified date at 16:00 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 60 years). Medical history included obesity. Family Medical History included Father passed away from heart disease and brother passed away from Leukemia. The patient experienced anaphylactic reaction and could not breathe on an unspecified date at 17:00. No history of all previous immunization with the Pfizer vaccine considered as suspect. No prior Vaccination received within four weeks prior to the first administration date of the suspect vaccine. The adverse events resulted in emergency room visit. No Adverse events following prior vaccinations. It was reported that she has a physician on the line regarding the Pfizer COVID 19 vaccine, Comirnaty. He is a doctor and reported that his cousin had an anaphylactic reaction to the vaccine a couple of months ago. He wants to ask if there is any kind of skin test to test for allergy to it like a polysorbate or peg test. She has an antigen level of 1.1. She was fine and said it occurred 5-6 months ago. He did not know exact date. They gave her a bunch of medicine and she was able to breathe. She was not hospitalized. She went to the ER and was treated and released. It was potentially very dangerous. They had to give her an Epi pen. This was after first dose. She wanted to get 2nd dose and her allergist said no way. Her endocrinologist said to be careful and maybe get J&J or Moderna. He thinks it was the Polysorbate carrier with Pfizer. It happened soon after the vaccine. It appeared an hour after. She could not breathe and went to local ER. She took a thyroid medication, not a Synthroid, but another one. She was given EPI and other medications. The clinical outcome of the event was recovered on unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Dehydration, Fluid intake reduced
Clinical narrative: Pain in right arm; Headache; Chills; Temperature of 100.6 for several hours 11/3/2021; Could not get enough water down; Experiencing dehydration; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (booster) (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the right arm on 02Nov2021 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to vaccination which included influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) on 28Oct2021 for immunization. The patient did not receive any medication within two weeks of vaccination. The patient had no problem until 02Nov2021 at 21:30 and from then onwards she experienced pain in right arm, headache, chills and temperature of 100.6 for several hours 03Nov2021. She could not get enough water down and experienced dehydration. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 02Nov2021, the patient underwent body temperature test and the result was 100.6 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of temperature of 100.6 which lasted for several hours was resolved on 03Nov2021 however the clinical outcome of the events pain in right arm, headache, chills, could not get enough water down and experienced dehydration were resolving at the time of this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pain in extremity
Clinical narrative: Pain in right arm; Headache; Chills; Temperature of 100.6 for several hours 11/3/2021; Could not get enough water down; Experiencing dehydration; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (booster) (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the right arm on 02Nov2021 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to vaccination which included influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) on 28Oct2021 for immunization. The patient did not receive any medication within two weeks of vaccination. The patient had no problem until 02Nov2021 at 21:30 and from then onwards she experienced pain in right arm, headache, chills and temperature of 100.6 for several hours 03Nov2021. She could not get enough water down and experienced dehydration. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 02Nov2021, the patient underwent body temperature test and the result was 100.6 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of temperature of 100.6 which lasted for several hours was resolved on 03Nov2021 however the clinical outcome of the events pain in right arm, headache, chills, could not get enough water down and experienced dehydration were resolving at the time of this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood oestrogen, Blood oestrogen decreased, Depression, Disturbance in attention
Clinical narrative: started decreasing my periods; High anxiety; Lack of sleep; Lack of focus; Depression; Low estrogen / got tested for "my" low estrogen; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 12May2021, the patient started decreasing her periods, high anxiety, lack of sleep, lack of focus, low estrogen and depression. It was also reported that that the patient did not know what was going on with her for a couple of months. The patient started taking anxiety medicine and got tested for low estrogen. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event anxiety and low estrogen and included treatment with unspecified anxiety medicine and unspecified pill respectively. On an unknown date in 2021, the patient underwent lab test and procedure which included oestrogen test and the result was low estrogen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started 'decreasing my periods', high anxiety, lack of sleep, lack of focus, depression and 'low estrogen / got tested for "my" low estrogen' was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Oligomenorrhoea
Clinical narrative: started decreasing my periods; High anxiety; Lack of sleep; Lack of focus; Depression; Low estrogen / got tested for "my" low estrogen; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 12May2021, the patient started decreasing her periods, high anxiety, lack of sleep, lack of focus, low estrogen and depression. It was also reported that that the patient did not know what was going on with her for a couple of months. The patient started taking anxiety medicine and got tested for low estrogen. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event anxiety and low estrogen and included treatment with unspecified anxiety medicine and unspecified pill respectively. On an unknown date in 2021, the patient underwent lab test and procedure which included oestrogen test and the result was low estrogen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started 'decreasing my periods', high anxiety, lack of sleep, lack of focus, depression and 'low estrogen / got tested for "my" low estrogen' was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Developed malaise; Chills; Body aches; Fever; This is a spontaneous report from a contactable pharmacist. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via intramuscular route of administration in the right arm on 02Nov2021 at 10:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via intramuscular route of administration in the right arm on 12Oct2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 02Nov2021 at 22:30, about 12 hours after receiving vaccine dose, the patient developed malaise, chills, body aches and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events developed malaise, chills, body aches and fever were resolving at the time of this report.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy
Clinical narrative: Swollen lymphnodes in armpit of right arm; The patient received Johnson and Johnson vaccine on 08Mar2021 and received booster dose of BNT162b2; The patient received Johnson and Johnson vaccine on 08Mar2021 and received booster dose of BNT162b2; The patient received booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had known allergies to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient received other vaccines within four weeks of vaccination which included tetanus vaccine toxoid/ diphtheria vaccine toxoid/ pertussis vaccine acellular 5-component (ADACEL) and influenza vaccine (MANUFACTURER UNKNOWN); both via an unspecified route of administration in the right arm on 07Oct2021 for immunization. The patient previously received COVID-19 vaccine NRVV AD26 (JOHNSON AND JOHNSON VACCINE; Lot Number: 1805020) via an unspecified route of administration in the right arm on 08Mar2021 at 10:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 01Nov2021, the patient experienced swollen lymphnodes in armpit of right arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymphnodes in armpit of right arm was not resolved at the time of the report.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypokinesia, Vaccination site pain
Clinical narrative: Sore arm at injection site arm can barely move or lift it; Sore arm at injection site arm can barely move or lift it; This is a spontaneous report from a contactable other healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the right arm on 03Nov2021 at 14:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included sickle cell trait, pre-diabetic, gallstones/gallbladder disease, eczema and known allergy to grass. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication. On 03Nov2021 at 16:00, the patient experienced sore arm at injection site and could barely move or lift it. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm at injection site can barely move or lift it was unknown at the time of this report.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Palpitations, Urticaria
Clinical narrative: Sore arm at injection site arm can barely move or lift it; Sore arm at injection site arm can barely move or lift it; This is a spontaneous report from a contactable other healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the right arm on 03Nov2021 at 14:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included sickle cell trait, pre-diabetic, gallstones/gallbladder disease, eczema and known allergy to grass. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication. On 03Nov2021 at 16:00, the patient experienced sore arm at injection site and could barely move or lift it. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm at injection site can barely move or lift it was unknown at the time of this report.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Ischaemic stroke, Thrombosis
Clinical narrative: brain stroke and blood clot; brain stroke and blood clot; patient collapsed; This is a spontaneous report from a contactable consumer.     A 79-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 31Jul2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation (Age at vaccination 79 years).  The patient medical history was not reported.     There were no concomitant medications.  The patient experienced brain stroke and blood clot  on 31Jul2021 22:00. patient collapsed (fall) (hospitalization, disability, life threatening) on 31Jul2021 22:00 with outcome of not recovered.  The patient was hospitalized for brain stroke, blood clot and fall  for 58 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on Sep2021 (Nasal Swab).  Unknown therapeutic measures were taken as a result of brain stroke and blood clot  and fall.  The patient died on an unspecified date because of stroke and clots.  It was not reported if an autopsy was performed.  Course of the event. Patient received the 1st shot of Pfizer Covid-19 vaccine on July 31st 2021 at 4 PM and at 10 PM patient collapsed due to blood clot and due to Brain Stroke and Patient died few weeks later due to the damage from the blood clot and brain stroke.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Ischaemic stroke; blood clot
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Body temperature, Chills, Computerised tomogram
Clinical narrative: Stated that she is very tired (fatigued); Nausea; Stated that all her joints hurt so bad; She could hardly get out of bed; Exhausted; Gained weight; Chills; Pulmonary hypertension; Trouble breathing; Fever/ fever was 101.6; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FF2593), dose 3 via an unspecified route of administration, administered in left arm on 28Oct2021 (at age of 81-year-old) as dose 3 (booster), single for covid-19 immunization. Medical history included pulmonary hypertension from 2015 to an unknown date, sleep apnoea syndrome (she used CPAP starting a couple of years because she had sleep apnoea). There were no concomitant medications. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration on 29Mar2021 (at age of 80-year-old) as dose 1, single; and then second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration on 26Apr2021 (at age of 80-year-old) as dose 2, single for covid-19 immunization. The patient experienced pulmonary hypertension, trouble breathing, fever/fever was 101.6, chills, stated that all her joints hurt so bad, she could hardly get out of bed, exhausted, gained weight on 28Oct2021, stated that she is very tired (fatigued), nausea on 29Oct2021. She stated that she is not as tired as she was the first couple of days, she is normally on two for oxygen and she has to turn it up to three at night, she had to have it on three all the time, today she has it set on two. Tylenol received for treatment of fever. The patient underwent lab tests and procedures which included body temperature: 101.6 on an unspecified date, computerised tomogram: unknown results on an unspecified date, weight: gained on an unspecified date. The outcome of event pulmonary hypertension, trouble breathing, she could hardly get out of bed, exhausted, gained weight was unknown; fever/fever was 101.6 was recovered with sequelae on 02Nov2021; stated that she is very tired, stated that all her joints hurt so bad was recovering; chills was recovered on 02Nov2021, nausea was recovered on 01Nov2021.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Nausea, Pulmonary hypertension, Pyrexia
Clinical narrative: Stated that she is very tired (fatigued); Nausea; Stated that all her joints hurt so bad; She could hardly get out of bed; Exhausted; Gained weight; Chills; Pulmonary hypertension; Trouble breathing; Fever/ fever was 101.6; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FF2593), dose 3 via an unspecified route of administration, administered in left arm on 28Oct2021 (at age of 81-year-old) as dose 3 (booster), single for covid-19 immunization. Medical history included pulmonary hypertension from 2015 to an unknown date, sleep apnoea syndrome (she used CPAP starting a couple of years because she had sleep apnoea). There were no concomitant medications. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration on 29Mar2021 (at age of 80-year-old) as dose 1, single; and then second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration on 26Apr2021 (at age of 80-year-old) as dose 2, single for covid-19 immunization. The patient experienced pulmonary hypertension, trouble breathing, fever/fever was 101.6, chills, stated that all her joints hurt so bad, she could hardly get out of bed, exhausted, gained weight on 28Oct2021, stated that she is very tired (fatigued), nausea on 29Oct2021. She stated that she is not as tired as she was the first couple of days, she is normally on two for oxygen and she has to turn it up to three at night, she had to have it on three all the time, today she has it set on two. Tylenol received for treatment of fever. The patient underwent lab tests and procedures which included body temperature: 101.6 on an unspecified date, computerised tomogram: unknown results on an unspecified date, weight: gained on an unspecified date. The outcome of event pulmonary hypertension, trouble breathing, she could hardly get out of bed, exhausted, gained weight was unknown; fever/fever was 101.6 was recovered with sequelae on 02Nov2021; stated that she is very tired, stated that all her joints hurt so bad was recovering; chills was recovered on 02Nov2021, nausea was recovered on 01Nov2021.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight increased
Clinical narrative: Stated that she is very tired (fatigued); Nausea; Stated that all her joints hurt so bad; She could hardly get out of bed; Exhausted; Gained weight; Chills; Pulmonary hypertension; Trouble breathing; Fever/ fever was 101.6; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FF2593), dose 3 via an unspecified route of administration, administered in left arm on 28Oct2021 (at age of 81-year-old) as dose 3 (booster), single for covid-19 immunization. Medical history included pulmonary hypertension from 2015 to an unknown date, sleep apnoea syndrome (she used CPAP starting a couple of years because she had sleep apnoea). There were no concomitant medications. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration on 29Mar2021 (at age of 80-year-old) as dose 1, single; and then second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration on 26Apr2021 (at age of 80-year-old) as dose 2, single for covid-19 immunization. The patient experienced pulmonary hypertension, trouble breathing, fever/fever was 101.6, chills, stated that all her joints hurt so bad, she could hardly get out of bed, exhausted, gained weight on 28Oct2021, stated that she is very tired (fatigued), nausea on 29Oct2021. She stated that she is not as tired as she was the first couple of days, she is normally on two for oxygen and she has to turn it up to three at night, she had to have it on three all the time, today she has it set on two. Tylenol received for treatment of fever. The patient underwent lab tests and procedures which included body temperature: 101.6 on an unspecified date, computerised tomogram: unknown results on an unspecified date, weight: gained on an unspecified date. The outcome of event pulmonary hypertension, trouble breathing, she could hardly get out of bed, exhausted, gained weight was unknown; fever/fever was 101.6 was recovered with sequelae on 02Nov2021; stated that she is very tired, stated that all her joints hurt so bad was recovering; chills was recovered on 02Nov2021, nausea was recovered on 01Nov2021.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site rash
Clinical narrative: This is a spontaneous report from a contactable consumer, (patient). A 60-year-old (non-pregnant) female patient received the third dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# FH8028), at the age of 60, via an unspecified route of administration, in the left arm, on Oct 31, 2021, at 10:15, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8734), at the age of 60, via an unspecified route of administration, in the left arm, on Mar 31, 2021, at 11:45; and received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0172), at the age of 60, via an unspecified route of administration, in the left arm, on Apr 21, 2021, at 11:30; both single dose, for COVID-19 immunisation. On Nov 3, 2021 (72 hours after the vaccine), patient experienced rash at injection site. The events did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Therapeutic measures taken as a result of rash at injection site included treatment with ice (iced site) and an unspecified topical steroid cream. Since the vaccination, patient has not tested for COVID-19. The outcome of rash at injection site: not resolved (at the time of this report).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Lymphadenopathy
Clinical narrative: Third/booster dose of BNT162b2; Chills; Swollen lymph node in arm of the injection; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 01Nov2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (MANUFACTURER UNKNOWN) within four weeks of the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 20Jan2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the arm left on 10Feb2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Nov2021, the patient experienced chills and swollen lymph node in arm of the injection. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills and swollen lymph node in arm of the injection was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Urinary incontinence
Clinical narrative: Lost complete bladder control for about 12 hours after having the booster / No matter how little "I" had in there or how much "I" tried to hold it in it just dribbled out; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the right arm on 31Oct2021 at 17:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient was allergic to some latex and sulfites. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received sumatriptan succinate (IMITREX) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 09Feb2021 at 16:00 (at the age of 67-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 02Mar2021 at 16:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 31Oct2021 at 23:00, after having the booster, the patient lost complete bladder control for about 12 hours. It was also reported that no matter how little she had in there or how much she had tried to hold it in, it just dribbled out. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lost complete bladder control for about 12 hours after having the booster / No matter how little "I" had in there or how much "I" tried to hold it in it just dribbled out was resolved on 01Nov2021 at 11:00.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Disturbance in attention, Headache, Myalgia, Pain in extremity
Clinical narrative: Pain in my legs, lower back, left bicep, and head; Pain in my legs, lower back, left bicep, and head; Pain in my legs, lower back, left bicep, and head; Pain in my legs, lower back, left bicep, and head; Drowsiness; Difficulty concentrating; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration in the left arm on 02Nov2021 at 17:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration in the left arm on 12Oct2021 at 17:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 03Nov2021 at 12:00, the patient experienced pain in his legs, lower back, left bicep and head, drowsiness and difficulty concentrating. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in my legs, lower back, left bicep and head, drowsiness and difficulty concentrating was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Pain in my legs, lower back, left bicep, and head; Pain in my legs, lower back, left bicep, and head; Pain in my legs, lower back, left bicep, and head; Pain in my legs, lower back, left bicep, and head; Drowsiness; Difficulty concentrating; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration in the left arm on 02Nov2021 at 17:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration in the left arm on 12Oct2021 at 17:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 03Nov2021 at 12:00, the patient experienced pain in his legs, lower back, left bicep and head, drowsiness and difficulty concentrating. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in my legs, lower back, left bicep and head, drowsiness and difficulty concentrating was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: Tinnitus; Ongoing fatigue; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. On 01May2021, the patient experienced tinnitus and fatigue which was ongoing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event tinnitus and included tinnitus therapy and hearing treatment. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus and ongoing fatigue were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.