chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: nauseous; definitely achy; fever/101.3 fever/feverish; feels un well/I was feeling a little off; chills; sore; tiredness.; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller reported that she received the second dose of vaccine yesterday afternoon. Today (24Mar2021) she had a fever of 101.3, and she felt unwell. Caller reported that she took Tylenol. She said last night (23Mar2021) she was feeling a little off. She woke up, she had chills, achy and sore all night and she woke up this morning (24Mar2021) with 101.3 fever and just feeling off like little nauseous and definitely achy and feverish. Reporter (patient) was experiencing flu-like symptoms like 101.3°F fever, body aches and tiredness. She would like to report these symptoms. She also was asking if she can infect her son who was at home. The patient underwent lab tests and procedures which included body temperature: 101.3 Fahrenheit on 24Mar2021. Therapeutic measures were taken as a result of pyrexia, malaise, nausea, definitely achy, feverish and chills. The outcome of all events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Headache
Clinical narrative: CVST  ? Symptoms: HA, LOC resulting in fall + head trauma  ? Outcome: Hemorrhagic infarct related to thrombosis of the superior sagittal sinus and regional cortical veins s/p emergent decompressive hemicraniectomy + thrombectomy, trach and PEG, discharged to SAR
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Mechanical ventilation, Mental impairment, Seizure
Clinical narrative: CVST  ? Symptoms: HA, LOC resulting in fall + head trauma  ? Outcome: Hemorrhagic infarct related to thrombosis of the superior sagittal sinus and regional cortical veins s/p emergent decompressive hemicraniectomy + thrombectomy, trach and PEG, discharged to SAR
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Craniectomy, Platelet count decreased
Clinical narrative: CVST  ? Symptoms: HA, LOC resulting in fall + head trauma  ? Outcome: Hemorrhagic infarct related to thrombosis of the superior sagittal sinus and regional cortical veins s/p emergent decompressive hemicraniectomy + thrombectomy, trach and PEG, discharged to SAR
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet transfusion, Thrombectomy, Thrombocytopenia
Clinical narrative: CVST  ? Symptoms: HA, LOC resulting in fall + head trauma  ? Outcome: Hemorrhagic infarct related to thrombosis of the superior sagittal sinus and regional cortical veins s/p emergent decompressive hemicraniectomy + thrombectomy, trach and PEG, discharged to SAR
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral thrombosis, Intensive care, Surgery
Clinical narrative: CVST  ? Symptoms: HA, LOC resulting in fall + head trauma  ? Outcome: Hemorrhagic infarct related to thrombosis of the superior sagittal sinus and regional cortical veins s/p emergent decompressive hemicraniectomy + thrombectomy, trach and PEG, discharged to SAR
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Brain oedema, Brain operation, Cerebral thrombosis, Cerebrovascular accident, Headache
Clinical narrative: CVST  ? Symptoms: HA, LOC resulting in fall + head trauma  ? Outcome: Hemorrhagic infarct related to thrombosis of the superior sagittal sinus and regional cortical veins s/p emergent decompressive hemicraniectomy + thrombectomy, trach and PEG, discharged to SAR
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hemiplegia, Intensive care, Seizure
Clinical narrative: CVST  ? Symptoms: HA, LOC resulting in fall + head trauma  ? Outcome: Hemorrhagic infarct related to thrombosis of the superior sagittal sinus and regional cortical veins s/p emergent decompressive hemicraniectomy + thrombectomy, trach and PEG, discharged to SAR
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Activated partial thromboplastin time prolonged, Blood fibrinogen normal, Brain oedema, Cerebral infarction, Cerebral ischaemia
Clinical narrative: CVST  ? Symptoms: HA, LOC resulting in fall + head trauma  ? Outcome: Hemorrhagic infarct related to thrombosis of the superior sagittal sinus and regional cortical veins s/p emergent decompressive hemicraniectomy + thrombectomy, trach and PEG, discharged to SAR
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral mass effect, Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Cytotoxic oedema, Decompressive craniectomy
Clinical narrative: CVST  ? Symptoms: HA, LOC resulting in fall + head trauma  ? Outcome: Hemorrhagic infarct related to thrombosis of the superior sagittal sinus and regional cortical veins s/p emergent decompressive hemicraniectomy + thrombectomy, trach and PEG, discharged to SAR
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fall, Fibrin D dimer, Gastrostomy, Haemorrhagic infarction, Head injury
Clinical narrative: CVST  ? Symptoms: HA, LOC resulting in fall + head trauma  ? Outcome: Hemorrhagic infarct related to thrombosis of the superior sagittal sinus and regional cortical veins s/p emergent decompressive hemicraniectomy + thrombectomy, trach and PEG, discharged to SAR
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Heparin-induced thrombocytopenia test, Loss of consciousness, Magnetic resonance imaging head abnormal, Platelet count decreased
Clinical narrative: CVST  ? Symptoms: HA, LOC resulting in fall + head trauma  ? Outcome: Hemorrhagic infarct related to thrombosis of the superior sagittal sinus and regional cortical veins s/p emergent decompressive hemicraniectomy + thrombectomy, trach and PEG, discharged to SAR
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Prothrombin time prolonged, SARS-CoV-2 test, Superior sagittal sinus thrombosis, Thrombectomy, Tracheostomy
Clinical narrative: CVST  ? Symptoms: HA, LOC resulting in fall + head trauma  ? Outcome: Hemorrhagic infarct related to thrombosis of the superior sagittal sinus and regional cortical veins s/p emergent decompressive hemicraniectomy + thrombectomy, trach and PEG, discharged to SAR
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Transverse sinus thrombosis, Vasogenic cerebral oedema, Venogram abnormal
Clinical narrative: CVST  ? Symptoms: HA, LOC resulting in fall + head trauma  ? Outcome: Hemorrhagic infarct related to thrombosis of the superior sagittal sinus and regional cortical veins s/p emergent decompressive hemicraniectomy + thrombectomy, trach and PEG, discharged to SAR
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Atrial pressure, Brain natriuretic peptide normal, Chest X-ray abnormal
Clinical narrative: Patient suffered a left lower extremity DVT with subsequent pulmonary embolus requiring hospitalization.  He returned to the facility after a 2 day hospital course and was placed on warfarin and a lovenox bridge.  On the day after his return from the hospital he became dyspneic and tachycardic and was sent by ambulance to the ER.  He was diagnosed with bilateral pulmonary emboli and pneumonia.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Dyspnoea exertional, Echocardiogram abnormal, Ejection fraction normal, Embolism arterial
Clinical narrative: Patient suffered a left lower extremity DVT with subsequent pulmonary embolus requiring hospitalization.  He returned to the facility after a 2 day hospital course and was placed on warfarin and a lovenox bridge.  On the day after his return from the hospital he became dyspneic and tachycardic and was sent by ambulance to the ER.  He was diagnosed with bilateral pulmonary emboli and pneumonia.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Lung opacity, Peripheral artery thrombosis, Peripheral vein occlusion, Pneumonia
Clinical narrative: Patient suffered a left lower extremity DVT with subsequent pulmonary embolus requiring hospitalization.  He returned to the facility after a 2 day hospital course and was placed on warfarin and a lovenox bridge.  On the day after his return from the hospital he became dyspneic and tachycardic and was sent by ambulance to the ER.  He was diagnosed with bilateral pulmonary emboli and pneumonia.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary arterial pressure normal, Pulmonary embolism, Right ventricular dysfunction, Tricuspid valve incompetence, Troponin normal
Clinical narrative: Patient suffered a left lower extremity DVT with subsequent pulmonary embolus requiring hospitalization.  He returned to the facility after a 2 day hospital course and was placed on warfarin and a lovenox bridge.  On the day after his return from the hospital he became dyspneic and tachycardic and was sent by ambulance to the ER.  He was diagnosed with bilateral pulmonary emboli and pneumonia.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler abnormal, Vaccination complication, Venous occlusion
Clinical narrative: Patient suffered a left lower extremity DVT with subsequent pulmonary embolus requiring hospitalization.  He returned to the facility after a 2 day hospital course and was placed on warfarin and a lovenox bridge.  On the day after his return from the hospital he became dyspneic and tachycardic and was sent by ambulance to the ER.  He was diagnosed with bilateral pulmonary emboli and pneumonia.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood gases, Deep vein thrombosis, Dyspnoea, Full blood count
Clinical narrative: Patient suffered a left lower extremity DVT with subsequent pulmonary embolus requiring hospitalization.  He returned to the facility after a 2 day hospital course and was placed on warfarin and a lovenox bridge.  On the day after his return from the hospital he became dyspneic and tachycardic and was sent by ambulance to the ER.  He was diagnosed with bilateral pulmonary emboli and pneumonia.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Pneumonia, Pulmonary embolism, Tachycardia, Troponin
Clinical narrative: Patient suffered a left lower extremity DVT with subsequent pulmonary embolus requiring hospitalization.  He returned to the facility after a 2 day hospital course and was placed on warfarin and a lovenox bridge.  On the day after his return from the hospital he became dyspneic and tachycardic and was sent by ambulance to the ER.  He was diagnosed with bilateral pulmonary emboli and pneumonia.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-, Additional Details: no taste. stomach issue
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Gastric disorder, Interchange of vaccine products, Paraesthesia
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-, Additional Details: no taste. stomach issue
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Headache, Magnetic resonance imaging, Urine analysis
Clinical narrative: Nine days after the vaccine ALL of my LONG COVID symptoms (which I had July 2020- October 2020) returned, beginning with a severe episode of vertigo on 5/1/2021. Then the symptoms from my first round of post-viral illness immediately returned, including disequilibrium (like walking on a trampoline/boat), head pressure, headaches, full eustachian tubes. This lasted from May 1 through Aug 1. In late July I traveled. Following my return to my symptoms worsened and, in addition to all previous symptoms, I started to experience electric-like tremors in my torso and head, and heart-rate spikes with minimal exertion (dysautonomia/POTS), shooting pains in my head.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Angiogram cerebral, Autonomic nervous system imbalance, Balance disorder, Brain stem auditory evoked response
Clinical narrative: Nine days after the vaccine ALL of my LONG COVID symptoms (which I had July 2020- October 2020) returned, beginning with a severe episode of vertigo on 5/1/2021. Then the symptoms from my first round of post-viral illness immediately returned, including disequilibrium (like walking on a trampoline/boat), head pressure, headaches, full eustachian tubes. This lasted from May 1 through Aug 1. In late July I traveled. Following my return to my symptoms worsened and, in addition to all previous symptoms, I started to experience electric-like tremors in my torso and head, and heart-rate spikes with minimal exertion (dysautonomia/POTS), shooting pains in my head.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cytokine increased, Eustachian tube disorder, Head discomfort, Headache, Heart rate increased
Clinical narrative: Nine days after the vaccine ALL of my LONG COVID symptoms (which I had July 2020- October 2020) returned, beginning with a severe episode of vertigo on 5/1/2021. Then the symptoms from my first round of post-viral illness immediately returned, including disequilibrium (like walking on a trampoline/boat), head pressure, headaches, full eustachian tubes. This lasted from May 1 through Aug 1. In late July I traveled. Following my return to my symptoms worsened and, in addition to all previous symptoms, I started to experience electric-like tremors in my torso and head, and heart-rate spikes with minimal exertion (dysautonomia/POTS), shooting pains in my head.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Pain, Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test negative
Clinical narrative: Nine days after the vaccine ALL of my LONG COVID symptoms (which I had July 2020- October 2020) returned, beginning with a severe episode of vertigo on 5/1/2021. Then the symptoms from my first round of post-viral illness immediately returned, including disequilibrium (like walking on a trampoline/boat), head pressure, headaches, full eustachian tubes. This lasted from May 1 through Aug 1. In late July I traveled. Following my return to my symptoms worsened and, in addition to all previous symptoms, I started to experience electric-like tremors in my torso and head, and heart-rate spikes with minimal exertion (dysautonomia/POTS), shooting pains in my head.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Ultrasound Doppler, Vertigo
Clinical narrative: Nine days after the vaccine ALL of my LONG COVID symptoms (which I had July 2020- October 2020) returned, beginning with a severe episode of vertigo on 5/1/2021. Then the symptoms from my first round of post-viral illness immediately returned, including disequilibrium (like walking on a trampoline/boat), head pressure, headaches, full eustachian tubes. This lasted from May 1 through Aug 1. In late July I traveled. Following my return to my symptoms worsened and, in addition to all previous symptoms, I started to experience electric-like tremors in my torso and head, and heart-rate spikes with minimal exertion (dysautonomia/POTS), shooting pains in my head.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PULMONARY EMBOLISM; COVID-19; EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 59 year old white (non-Hispanic or Latino) male. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 diabetes, hyperlipidemia, and hypertension (HT), and other pre-existing medical conditions included: Patient had experienced allergies dry cough when treated with (Angiotensin-converting-enzyme) ACE inhibitors. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: 23-AUG-2021) dose was not reported, 01 total, administered at left arm on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced expired vaccine administered. On 28-AUG-2021, the patient experienced symptoms like dry cough, fatigue, headache, diarrhea and later on they were informed 30-AUG-2021, the patient got covid-19. On 08-SEP-2021 he was admitted to hospital for 8 days. During that time in SEP-2021 he was diagnosed with pulmonary embolism (PE) and were not sure whether it was due to covid or it was pre-existing as the documentations did not say it was secondary due to covid-19. He had not received monoclonal antibodies. The patient was discharged on 15-SEP-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19, and pulmonary embolism, and the outcome of expired vaccine administered was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20211006895-COVID-19 VACCINE AD26.COV2.S-Pulmonary embolism, COVID-19. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Expired product administered, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; COVID-19; EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 59 year old white (non-Hispanic or Latino) male. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 diabetes, hyperlipidemia, and hypertension (HT), and other pre-existing medical conditions included: Patient had experienced allergies dry cough when treated with (Angiotensin-converting-enzyme) ACE inhibitors. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: 23-AUG-2021) dose was not reported, 01 total, administered at left arm on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced expired vaccine administered. On 28-AUG-2021, the patient experienced symptoms like dry cough, fatigue, headache, diarrhea and later on they were informed 30-AUG-2021, the patient got covid-19. On 08-SEP-2021 he was admitted to hospital for 8 days. During that time in SEP-2021 he was diagnosed with pulmonary embolism (PE) and were not sure whether it was due to covid or it was pre-existing as the documentations did not say it was secondary due to covid-19. He had not received monoclonal antibodies. The patient was discharged on 15-SEP-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19, and pulmonary embolism, and the outcome of expired vaccine administered was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20211006895-COVID-19 VACCINE AD26.COV2.S-Pulmonary embolism, COVID-19. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mass, Pain in extremity, Peripheral swelling
Clinical narrative: she experienced injection site swelling which looks like a lump; she experienced injection site swelling which looks like a lump; itchiness; her arm swelled and was sore; her arm swelled and was sore; This is a spontaneous report from a contactable consumer, the patient.   A female patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 18Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient said that after the first dose she did not get any side effect but on the second dose which she got last 18March2021, she experienced injection site swelling which looked like a lump and itchiness on an unknown date in 2021. The patient reported that after 2nd dose her arm swelled and was sore on an unknown date in 2021. She asked what she would do with this and if it will eventually subside. She was told to put ice on it and did that, but it was not working and now there is a lump on an unknown date in 2021. She wants to know if the lump will go away, and her arm is still. She was asking the percentage of the people who has gotten the same side effects as hers. She stated that she is already done with the two doses of the vaccine. She also asked if the first and the second dose of the vaccine has the same ingredient. The patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. The outcome of all the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Vaccination site mass, Vaccination site swelling
Clinical narrative: she experienced injection site swelling which looks like a lump; she experienced injection site swelling which looks like a lump; itchiness; her arm swelled and was sore; her arm swelled and was sore; This is a spontaneous report from a contactable consumer, the patient.   A female patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 18Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient said that after the first dose she did not get any side effect but on the second dose which she got last 18March2021, she experienced injection site swelling which looked like a lump and itchiness on an unknown date in 2021. The patient reported that after 2nd dose her arm swelled and was sore on an unknown date in 2021. She asked what she would do with this and if it will eventually subside. She was told to put ice on it and did that, but it was not working and now there is a lump on an unknown date in 2021. She wants to know if the lump will go away, and her arm is still. She was asking the percentage of the people who has gotten the same side effects as hers. She stated that she is already done with the two doses of the vaccine. She also asked if the first and the second dose of the vaccine has the same ingredient. The patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. The outcome of all the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Myalgia, Tinnitus
Clinical narrative: sore arm at injection site; extreme fatigue; Severe muscle and join pain; Severe muscle and join pain; Tinnitus in both ears; Can't sleep; Hard to hear; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer (patient) reported for herself that she received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: ER8731, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Right on 16Apr2021 (age at vaccination: 64years-old) as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing Only hypothyroid otherwise remarkably healthy and Concomitant medications included levothyroxine (LEVOTHYROXINE) 100 mg, 1x/day taken for an unspecified indication from an unspecified start date and ongoing. Patient was not pregnant at the time of Vaccination. The patient previously took dose 1 bnt162b2(Lot number: ER8732, Expiry date: Unknown), administered in Arm Right on 26Mar2021 for covid-19 immunisation. Past drug included pseudoephedrine and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior and other medications included Levothyroxine 2 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. It was reported that patient did not experience any initial side effects to either first or second dose other than a sore arm at the injection site. However, approximately a week later, began to experience severe body, joint aches accompanied by extreme fatigue and these symptoms have persisted. At the same time, patient also began to experience tinnitus in both ears, was told that it should go away In a few weeks to a few months and shouId just give it time but not only has it not gone away, it has become significantly worse, now 5 months after the second dose. The sounds in ears persist 24-hours a day, interfere with sleeping and are now affecting ability to hear clearly as it has gotten worse. Never had any ear or hearing issues, no workplace exposure, don't use earphones or earbuds and never had tinnitus before). Patient had been contacted multiple medical practices that see patients for tinnitus. All have told the same thing- there is no test for tinnitus, there is no cure and the only current treatments they could offer would be such things as white noise machines to block the constant high-pitched sound. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on an unspecified date, Positive for antibodies from the vaccine. Patient did not received treatment for any event. The outcome of the events were not recovered.  No follow-up attempts are needed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Hypoacusis, Insomnia, Myalgia
Clinical narrative: sore arm at injection site; extreme fatigue; Severe muscle and join pain; Severe muscle and join pain; Tinnitus in both ears; Can't sleep; Hard to hear; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer (patient) reported for herself that she received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: ER8731, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Right on 16Apr2021 (age at vaccination: 64years-old) as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing Only hypothyroid otherwise remarkably healthy and Concomitant medications included levothyroxine (LEVOTHYROXINE) 100 mg, 1x/day taken for an unspecified indication from an unspecified start date and ongoing. Patient was not pregnant at the time of Vaccination. The patient previously took dose 1 bnt162b2(Lot number: ER8732, Expiry date: Unknown), administered in Arm Right on 26Mar2021 for covid-19 immunisation. Past drug included pseudoephedrine and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior and other medications included Levothyroxine 2 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. It was reported that patient did not experience any initial side effects to either first or second dose other than a sore arm at the injection site. However, approximately a week later, began to experience severe body, joint aches accompanied by extreme fatigue and these symptoms have persisted. At the same time, patient also began to experience tinnitus in both ears, was told that it should go away In a few weeks to a few months and shouId just give it time but not only has it not gone away, it has become significantly worse, now 5 months after the second dose. The sounds in ears persist 24-hours a day, interfere with sleeping and are now affecting ability to hear clearly as it has gotten worse. Never had any ear or hearing issues, no workplace exposure, don't use earphones or earbuds and never had tinnitus before). Patient had been contacted multiple medical practices that see patients for tinnitus. All have told the same thing- there is no test for tinnitus, there is no cure and the only current treatments they could offer would be such things as white noise machines to block the constant high-pitched sound. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on an unspecified date, Positive for antibodies from the vaccine. Patient did not received treatment for any event. The outcome of the events were not recovered.  No follow-up attempts are needed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Tinnitus, Vaccination site pain
Clinical narrative: sore arm at injection site; extreme fatigue; Severe muscle and join pain; Severe muscle and join pain; Tinnitus in both ears; Can't sleep; Hard to hear; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer (patient) reported for herself that she received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: ER8731, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Right on 16Apr2021 (age at vaccination: 64years-old) as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing Only hypothyroid otherwise remarkably healthy and Concomitant medications included levothyroxine (LEVOTHYROXINE) 100 mg, 1x/day taken for an unspecified indication from an unspecified start date and ongoing. Patient was not pregnant at the time of Vaccination. The patient previously took dose 1 bnt162b2(Lot number: ER8732, Expiry date: Unknown), administered in Arm Right on 26Mar2021 for covid-19 immunisation. Past drug included pseudoephedrine and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior and other medications included Levothyroxine 2 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. It was reported that patient did not experience any initial side effects to either first or second dose other than a sore arm at the injection site. However, approximately a week later, began to experience severe body, joint aches accompanied by extreme fatigue and these symptoms have persisted. At the same time, patient also began to experience tinnitus in both ears, was told that it should go away In a few weeks to a few months and shouId just give it time but not only has it not gone away, it has become significantly worse, now 5 months after the second dose. The sounds in ears persist 24-hours a day, interfere with sleeping and are now affecting ability to hear clearly as it has gotten worse. Never had any ear or hearing issues, no workplace exposure, don't use earphones or earbuds and never had tinnitus before). Patient had been contacted multiple medical practices that see patients for tinnitus. All have told the same thing- there is no test for tinnitus, there is no cure and the only current treatments they could offer would be such things as white noise machines to block the constant high-pitched sound. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on an unspecified date, Positive for antibodies from the vaccine. Patient did not received treatment for any event. The outcome of the events were not recovered.  No follow-up attempts are needed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: Painful spasms on top of the right foot and in the right arm were reported to pharmacyr was told about the foot and was considering Calcium. I tried that and Magnesium. I am now trying EMS stimulation but it is not effective yet.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Painful spasms on top of the right foot and in the right arm were reported to pharmacyr was told about the foot and was considering Calcium. I tried that and Magnesium. I am now trying EMS stimulation but it is not effective yet.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Headache, Intensive care
Clinical narrative: Acute cerebral sinus thrombosis. Symptoms: persistent headache, intermittent dizziness. Outcome: improved on anticoagulation, discharged after 3 day ICU stay with plans for f/u
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Jugular vein thrombosis, Transverse sinus thrombosis, Venogram abnormal
Clinical narrative: Acute cerebral sinus thrombosis. Symptoms: persistent headache, intermittent dizziness. Outcome: improved on anticoagulation, discharged after 3 day ICU stay with plans for f/u
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time prolonged, Angiogram, Anticoagulant therapy, Cerebral venous sinus thrombosis, Computerised tomogram head
Clinical narrative: Acute cerebral sinus thrombosis. Symptoms: persistent headache, intermittent dizziness. Outcome: improved on anticoagulation, discharged after 3 day ICU stay with plans for f/u
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Intensive care, Jugular vein thrombosis, Platelet count normal
Clinical narrative: Acute cerebral sinus thrombosis. Symptoms: persistent headache, intermittent dizziness. Outcome: improved on anticoagulation, discharged after 3 day ICU stay with plans for f/u
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Prothrombin time prolonged, Transverse sinus thrombosis, Venogram abnormal
Clinical narrative: Acute cerebral sinus thrombosis. Symptoms: persistent headache, intermittent dizziness. Outcome: improved on anticoagulation, discharged after 3 day ICU stay with plans for f/u
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse reaction, Burning sensation, Eye swelling, Intensive care, Laboratory test
Clinical narrative: I broke out in hives that covered anywhere I had skin/ I had large welts; itching on 100% of my body; My eyelids, lips, and throat swelled; My eyelids, lips, and throat swelled; My eyelids, lips, and throat swelled; My tongue became tingling; difficult to swallow; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), via an unspecified route of administration in left arm on 20Mar2021 at 10:00 (at the age of 55-years-old) at dose 2, single for COVID-19 immunization. Medical history was reported as none. She has no COVID prior to vaccination and has no known allergies. Concomitant medication included liraglutide (SAXENDA) and clonidine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration in right arm on 27Feb2021 at 10:00 (at the age of 55-years-old) at dose 1, single for COVID-19 immunization. There were no other vaccines in four weeks. Facility type was reported as other. She was not tested for COVID post vaccination. On 25Mar2021 at 15:00, the patient broke out in hives that covered anywhere she had skin. She had large welts and itching on 100% of her body. Her eyelids, lips, and throat swelled. Her tongue was tingling, and it was difficult for her to swallow. The events required emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. She was hospitalized for 6 days from an unspecified date in 2021 to an unspecified date in 2021. The events were also reported as life-threatening illness (immediate risk of death from the event) and caused disability or permanent damage. Therapeutic measures were taken as a result of the events. She was placed on medications and test was done on an unspecified date in 2021 with unknown result. The outcome of the events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Organ failure, Pharyngeal swelling, Pruritus, Septic shock
Clinical narrative: I broke out in hives that covered anywhere I had skin/ I had large welts; itching on 100% of my body; My eyelids, lips, and throat swelled; My eyelids, lips, and throat swelled; My eyelids, lips, and throat swelled; My tongue became tingling; difficult to swallow; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), via an unspecified route of administration in left arm on 20Mar2021 at 10:00 (at the age of 55-years-old) at dose 2, single for COVID-19 immunization. Medical history was reported as none. She has no COVID prior to vaccination and has no known allergies. Concomitant medication included liraglutide (SAXENDA) and clonidine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration in right arm on 27Feb2021 at 10:00 (at the age of 55-years-old) at dose 1, single for COVID-19 immunization. There were no other vaccines in four weeks. Facility type was reported as other. She was not tested for COVID post vaccination. On 25Mar2021 at 15:00, the patient broke out in hives that covered anywhere she had skin. She had large welts and itching on 100% of her body. Her eyelids, lips, and throat swelled. Her tongue was tingling, and it was difficult for her to swallow. The events required emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. She was hospitalized for 6 days from an unspecified date in 2021 to an unspecified date in 2021. The events were also reported as life-threatening illness (immediate risk of death from the event) and caused disability or permanent damage. Therapeutic measures were taken as a result of the events. She was placed on medications and test was done on an unspecified date in 2021 with unknown result. The outcome of the events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria, Urticarial vasculitis
Clinical narrative: I broke out in hives that covered anywhere I had skin/ I had large welts; itching on 100% of my body; My eyelids, lips, and throat swelled; My eyelids, lips, and throat swelled; My eyelids, lips, and throat swelled; My tongue became tingling; difficult to swallow; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), via an unspecified route of administration in left arm on 20Mar2021 at 10:00 (at the age of 55-years-old) at dose 2, single for COVID-19 immunization. Medical history was reported as none. She has no COVID prior to vaccination and has no known allergies. Concomitant medication included liraglutide (SAXENDA) and clonidine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration in right arm on 27Feb2021 at 10:00 (at the age of 55-years-old) at dose 1, single for COVID-19 immunization. There were no other vaccines in four weeks. Facility type was reported as other. She was not tested for COVID post vaccination. On 25Mar2021 at 15:00, the patient broke out in hives that covered anywhere she had skin. She had large welts and itching on 100% of her body. Her eyelids, lips, and throat swelled. Her tongue was tingling, and it was difficult for her to swallow. The events required emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. She was hospitalized for 6 days from an unspecified date in 2021 to an unspecified date in 2021. The events were also reported as life-threatening illness (immediate risk of death from the event) and caused disability or permanent damage. Therapeutic measures were taken as a result of the events. She was placed on medications and test was done on an unspecified date in 2021 with unknown result. The outcome of the events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Investigation, Lip swelling, Paraesthesia oral, Pharyngeal swelling
Clinical narrative: I broke out in hives that covered anywhere I had skin/ I had large welts; itching on 100% of my body; My eyelids, lips, and throat swelled; My eyelids, lips, and throat swelled; My eyelids, lips, and throat swelled; My tongue became tingling; difficult to swallow; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), via an unspecified route of administration in left arm on 20Mar2021 at 10:00 (at the age of 55-years-old) at dose 2, single for COVID-19 immunization. Medical history was reported as none. She has no COVID prior to vaccination and has no known allergies. Concomitant medication included liraglutide (SAXENDA) and clonidine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration in right arm on 27Feb2021 at 10:00 (at the age of 55-years-old) at dose 1, single for COVID-19 immunization. There were no other vaccines in four weeks. Facility type was reported as other. She was not tested for COVID post vaccination. On 25Mar2021 at 15:00, the patient broke out in hives that covered anywhere she had skin. She had large welts and itching on 100% of her body. Her eyelids, lips, and throat swelled. Her tongue was tingling, and it was difficult for her to swallow. The events required emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. She was hospitalized for 6 days from an unspecified date in 2021 to an unspecified date in 2021. The events were also reported as life-threatening illness (immediate risk of death from the event) and caused disability or permanent damage. Therapeutic measures were taken as a result of the events. She was placed on medications and test was done on an unspecified date in 2021 with unknown result. The outcome of the events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Swelling of eyelid, Urticaria
Clinical narrative: I broke out in hives that covered anywhere I had skin/ I had large welts; itching on 100% of my body; My eyelids, lips, and throat swelled; My eyelids, lips, and throat swelled; My eyelids, lips, and throat swelled; My tongue became tingling; difficult to swallow; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), via an unspecified route of administration in left arm on 20Mar2021 at 10:00 (at the age of 55-years-old) at dose 2, single for COVID-19 immunization. Medical history was reported as none. She has no COVID prior to vaccination and has no known allergies. Concomitant medication included liraglutide (SAXENDA) and clonidine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration in right arm on 27Feb2021 at 10:00 (at the age of 55-years-old) at dose 1, single for COVID-19 immunization. There were no other vaccines in four weeks. Facility type was reported as other. She was not tested for COVID post vaccination. On 25Mar2021 at 15:00, the patient broke out in hives that covered anywhere she had skin. She had large welts and itching on 100% of her body. Her eyelids, lips, and throat swelled. Her tongue was tingling, and it was difficult for her to swallow. The events required emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. She was hospitalized for 6 days from an unspecified date in 2021 to an unspecified date in 2021. The events were also reported as life-threatening illness (immediate risk of death from the event) and caused disability or permanent damage. Therapeutic measures were taken as a result of the events. She was placed on medications and test was done on an unspecified date in 2021 with unknown result. The outcome of the events was not recovered.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cerebral haemorrhage, Cerebral ischaemia, Cerebral thrombosis, Computerised tomogram abnormal
Clinical narrative: no feeling entire right side- stroke symptoms - collapsed; numbness in right leg; nausea; weakness; Severe dysstasia - Endovascular Thrombectomy procedure . Clots removed; Severe dysstasia - Endovascular Thrombectomy procedure . Clots removed; Tiredness/ fatigue / increased fatigue; lack of apatite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of bnt162b2 on 21Sep2021 at 10:00 (at the age of 59-years-old) (lot number: unknown) via unknown route of administration at single dose in arm right for COVID-19 immunization. Medical history and concomitant medications were not reported. There was no other vaccine in four weeks. Patient experienced Tiredness/ fatigue / increased fatigue on 21Sep2021; lack of apatite on 21Sep2021; weakness on 22Sep2021 at 10:00; nausea on 23Sep2021 at 10:00; numbness in right leg on 27Sep2021 at 10:00; no feeling entire right side- stroke symptoms - collapsed on 29Sep2021 at 10:00; Severe dysstasia - Endovascular Thrombectomy procedure, Clots removed on 22Sep2021 at 10:00. The events resulted in Emergency room visit, Hospitalization for three days, Life threatening illness (immediate risk of death from the event), Congenital anomaly. Patient received treatment for all events including Endovascular Thrombectomy. Patient did not have covid prior vaccination. It was not reported if patient had covid tested post vaccination. The outcome of the events was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.