chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast
Clinical narrative: I was hospitalized with high fever; swollen salivary glands with no drainage; This is a spontaneous report from COVAES from a contactable consumer (patient).   A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Left Arm on 20Apr2021 14:00 (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE (at the age of 64 years) for covid-19 immunisation.  The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number unknown) 29Mar2021 at 12:30 PM, in Left arm.  Medical history included asthma from an unknown date and unknown if ongoing and drug hypersensitivity to penicillin.  The patient's concomitant medications were not reported.  The patient did not receive any other medication within 2 weeks of vaccination.  Prior to vaccination the patient was not diagnosed with COVID-19.  The patient experienced hospitalization for high fever on 21Apr2021 with outcome of recovered and swollen salivary glands with no drainage (hospitalization) on 21Apr2021 with outcome of recovered.  The patient's hospitalization was prolonged as a result of these events.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Apr2021.  Therapeutic measures were taken as a result of high fever and swollen salivary glands with no drainage. The patient was not pregnant at time of Vaccination. The patient did not receive "any other" vaccines within 4 weeks prior to the COVID vaccine.    Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Salivary gland enlargement
Clinical narrative: I was hospitalized with high fever; swollen salivary glands with no drainage; This is a spontaneous report from COVAES from a contactable consumer (patient).   A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Left Arm on 20Apr2021 14:00 (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE (at the age of 64 years) for covid-19 immunisation.  The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number unknown) 29Mar2021 at 12:30 PM, in Left arm.  Medical history included asthma from an unknown date and unknown if ongoing and drug hypersensitivity to penicillin.  The patient's concomitant medications were not reported.  The patient did not receive any other medication within 2 weeks of vaccination.  Prior to vaccination the patient was not diagnosed with COVID-19.  The patient experienced hospitalization for high fever on 21Apr2021 with outcome of recovered and swollen salivary glands with no drainage (hospitalization) on 21Apr2021 with outcome of recovered.  The patient's hospitalization was prolonged as a result of these events.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Apr2021.  Therapeutic measures were taken as a result of high fever and swollen salivary glands with no drainage. The patient was not pregnant at time of Vaccination. The patient did not receive "any other" vaccines within 4 weeks prior to the COVID vaccine.    Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Ultrasound scan abnormal
Clinical narrative: BODY ACHES; CHILLS; FEVER; DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) 1 total, dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient had body aches, chills and fever. In APR-2021 (a week after vaccination), the patient experienced right leg pain and felt heavy and visited her primary care physician who recommended ultrasound scan of the leg. On 10-MAY-2021, the patient's ultrasound scan revealed deep vein thrombosis and she was treated with unspecified blood thinners. The patient was also put on Xarelto (rivaroxaban) therapy 15 milligram for 21 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on 11-APR-2021, and the outcome of deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210520235-covid-19 vaccine ad26.cov2.s -Deep vein thrombosis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Deep vein thrombosis, Pain, Pyrexia, Ultrasound scan
Clinical narrative: BODY ACHES; CHILLS; FEVER; DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) 1 total, dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient had body aches, chills and fever. In APR-2021 (a week after vaccination), the patient experienced right leg pain and felt heavy and visited her primary care physician who recommended ultrasound scan of the leg. On 10-MAY-2021, the patient's ultrasound scan revealed deep vein thrombosis and she was treated with unspecified blood thinners. The patient was also put on Xarelto (rivaroxaban) therapy 15 milligram for 21 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on 11-APR-2021, and the outcome of deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210520235-covid-19 vaccine ad26.cov2.s -Deep vein thrombosis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram normal, Blood test, Catheterisation cardiac normal, Chest pain, Echocardiogram normal
Clinical narrative: chest pain, myocarditis.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Myocarditis, Troponin increased
Clinical narrative: chest pain, myocarditis.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Catheterisation cardiac, Chest pain, Echocardiogram, Myocarditis
Clinical narrative: chest pain, myocarditis.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: chest pain, myocarditis.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Loss of consciousness, Pruritus, Wheezing
Clinical narrative: Ten minutes after receiving the vaccine I started to break out in hives. My face swelled up including my lips, throat, and tongue. Nurses at the clinic usetwo epipens and called 911. The paramedics used a third epipen, a breathing treatment, and sub q Benadryl.  I was rushed to a nearby hospital and intubated and given more epinephrine, steroids, benadryl, pepcid, and an epinephrine IV drip.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Pharyngeal swelling, Swelling face, Swollen tongue, Urticaria
Clinical narrative: Ten minutes after receiving the vaccine I started to break out in hives. My face swelled up including my lips, throat, and tongue. Nurses at the clinic usetwo epipens and called 911. The paramedics used a third epipen, a breathing treatment, and sub q Benadryl.  I was rushed to a nearby hospital and intubated and given more epinephrine, steroids, benadryl, pepcid, and an epinephrine IV drip.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site urticaria
Clinical narrative: Scattered 5-10 mm urticaria which came in clusters of 10-15 lesions.  The entire crop covered an area of perhaps 10x20 cm.  The first crop started around injection site and resolved after one day.  Each subsequent day, a similar crops developed and resolved.  These happened on the contralateral forearm, and face.  No new crops developing as of follow up call on 5/20/21.  OTC Benadryl PRN itching.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Scattered 5-10 mm urticaria which came in clusters of 10-15 lesions.  The entire crop covered an area of perhaps 10x20 cm.  The first crop started around injection site and resolved after one day.  Each subsequent day, a similar crops developed and resolved.  These happened on the contralateral forearm, and face.  No new crops developing as of follow up call on 5/20/21.  OTC Benadryl PRN itching.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood immunoglobulin G, Therapy non-responder
Clinical narrative: This spontaneous report received from a patient concerned a 28 year old. The patient's weight was 51 kilograms, and height was 150 centimeters. The patient was non-smoker, and non alcohol user. Patient had no known allergies, no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced body aches and fever. Patient recovered from body aches on 10-MAR-2021. On 10-MAY-2021, the patient performed antibody test which was negative (confirmed immunological vaccine failure) and the patient reported that the vaccine did not work for her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, was recovering from fever, and the outcome of confirmed immunological vaccine failure (Negative antibody test, vaccine did not work) was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179393. The suspected product quality complaint has been confirmed to be not voided, based on the PQC evaluation/investigation performed. Sender's Comments: V0: 20210525073-Confirmed immunological vaccine failure (negative antibody test, vaccine did not work). This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test negative, Pain, Pyrexia, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a 28 year old. The patient's weight was 51 kilograms, and height was 150 centimeters. The patient was non-smoker, and non alcohol user. Patient had no known allergies, no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced body aches and fever. Patient recovered from body aches on 10-MAR-2021. On 10-MAY-2021, the patient performed antibody test which was negative (confirmed immunological vaccine failure) and the patient reported that the vaccine did not work for her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, was recovering from fever, and the outcome of confirmed immunological vaccine failure (Negative antibody test, vaccine did not work) was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179393. The suspected product quality complaint has been confirmed to be not voided, based on the PQC evaluation/investigation performed. Sender's Comments: V0: 20210525073-Confirmed immunological vaccine failure (negative antibody test, vaccine did not work). This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Herpes zoster, Malaise
Clinical narrative: Heartburn; Lack of appetite; rash on my neck is inflamed and red; rash on my neck is inflamed and red; Rash on my arms; shingles outbreak/outbreak; Headache; Feverish; hot; itching under my skin/itches from head to toe; This is a spontaneous report received from contactable consumer (patient). This female patient of unspecified age, reported as 66, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunisation. Medical history included osteoporosis from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported breaking out in a rash on her neck and arms, stating the rash on her arm went away. She also reported she had a shingles outbreak that was on her back but that was drying up and it itched from head to toe. She stated that right after she got the injection she started itching under her skin; she stated the rash on her neck she got the day after she got the second injection which was on 31Mar2021. She reported the next day she woke up with a headache, feverish and was hot; she had an outbreak on her back and rash on her neck and arm. and the itching was "crazy." The patient reported the rash on her arm went away about a week later although the rash on her neck was inflamed and red; stating she used cortisone and diphenhydramine hydrochloride (BENADRYL) on it and it still wouldn't go away. She stated she had shots for osteoporosis on the "22nd" and she explained to her doctor, who told her to wait. She stated that it had been a week and the rash was still there. She inquired if she should hold off on getting the new injection for her osteoporosis, which was an injection given in her belly daily for 18 months, and wait until the rash clears up. She also reported she had heartburn and a lack of appetite, further stating even after she ate she had heartburn and was eating bland food. The clinical outcome of rash on her neck was inflamed and red was not recovered. The clinical outcome of rash on her arms was reported as recovered a week later; the outcomes of shingles outbreak/outbreak, itching under my skin/itches from head to toe, headache, feverish, hot, heartburn and lack of appetite were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Dermatitis, Dyspepsia, Feeling hot, Headache
Clinical narrative: Heartburn; Lack of appetite; rash on my neck is inflamed and red; rash on my neck is inflamed and red; Rash on my arms; shingles outbreak/outbreak; Headache; Feverish; hot; itching under my skin/itches from head to toe; This is a spontaneous report received from contactable consumer (patient). This female patient of unspecified age, reported as 66, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunisation. Medical history included osteoporosis from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported breaking out in a rash on her neck and arms, stating the rash on her arm went away. She also reported she had a shingles outbreak that was on her back but that was drying up and it itched from head to toe. She stated that right after she got the injection she started itching under her skin; she stated the rash on her neck she got the day after she got the second injection which was on 31Mar2021. She reported the next day she woke up with a headache, feverish and was hot; she had an outbreak on her back and rash on her neck and arm. and the itching was "crazy." The patient reported the rash on her arm went away about a week later although the rash on her neck was inflamed and red; stating she used cortisone and diphenhydramine hydrochloride (BENADRYL) on it and it still wouldn't go away. She stated she had shots for osteoporosis on the "22nd" and she explained to her doctor, who told her to wait. She stated that it had been a week and the rash was still there. She inquired if she should hold off on getting the new injection for her osteoporosis, which was an injection given in her belly daily for 18 months, and wait until the rash clears up. She also reported she had heartburn and a lack of appetite, further stating even after she ate she had heartburn and was eating bland food. The clinical outcome of rash on her neck was inflamed and red was not recovered. The clinical outcome of rash on her arms was reported as recovered a week later; the outcomes of shingles outbreak/outbreak, itching under my skin/itches from head to toe, headache, feverish, hot, heartburn and lack of appetite were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Pruritus, Pyrexia, Rash, Rash erythematous
Clinical narrative: Heartburn; Lack of appetite; rash on my neck is inflamed and red; rash on my neck is inflamed and red; Rash on my arms; shingles outbreak/outbreak; Headache; Feverish; hot; itching under my skin/itches from head to toe; This is a spontaneous report received from contactable consumer (patient). This female patient of unspecified age, reported as 66, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunisation. Medical history included osteoporosis from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported breaking out in a rash on her neck and arms, stating the rash on her arm went away. She also reported she had a shingles outbreak that was on her back but that was drying up and it itched from head to toe. She stated that right after she got the injection she started itching under her skin; she stated the rash on her neck she got the day after she got the second injection which was on 31Mar2021. She reported the next day she woke up with a headache, feverish and was hot; she had an outbreak on her back and rash on her neck and arm. and the itching was "crazy." The patient reported the rash on her arm went away about a week later although the rash on her neck was inflamed and red; stating she used cortisone and diphenhydramine hydrochloride (BENADRYL) on it and it still wouldn't go away. She stated she had shots for osteoporosis on the "22nd" and she explained to her doctor, who told her to wait. She stated that it had been a week and the rash was still there. She inquired if she should hold off on getting the new injection for her osteoporosis, which was an injection given in her belly daily for 18 months, and wait until the rash clears up. She also reported she had heartburn and a lack of appetite, further stating even after she ate she had heartburn and was eating bland food. The clinical outcome of rash on her neck was inflamed and red was not recovered. The clinical outcome of rash on her arms was reported as recovered a week later; the outcomes of shingles outbreak/outbreak, itching under my skin/itches from head to toe, headache, feverish, hot, heartburn and lack of appetite were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Computerised tomogram, Hypersensitivity, Lymphadenopathy
Clinical narrative: Allergic reaction; still have massively swollen lymph nodes on the left side of my neck and left shoulder; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old male patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 22Apr2021 14:15 (Batch/Lot Number: EW0151) at single dose for COVID-19 immunization. Medical history included known allergies shellfish and tree nuts and he might be allergic to iodine, asthma, high blood pressure, acid reflux. Concomitant medications included finasteride (PROPECIA), cetirizine hydrochloride (ZYRTEC R), metoprolol, lisinopril, pantoprazole sodium sesquihydrate (PANTOPROL), all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 31Mar2021 14:00 (Batch/Lot Number: EI28733) at single dose for COVID-19 immunization. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Allergic reaction within 5 minutes (also reported as 22Apr2021 14:30) of the dose. Rushed to ER and given an IV of steroids, antihistamines, and another drug he can't remember. The patient on week #2 and still had massively swollen lymph nodes on the left side of his neck and left shoulder.  Dr. prescribed additional steroids (second regimen since the reaction) and antibiotics.  The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event included An IV of Antihistamines, steroids, etc. Facility where the most recent COVID-19 vaccine was administered was Hospital. The outcome of the events was recovering.    Information on Lot/Batch number was available. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Swelling
Clinical narrative: Allergic reaction; still have massively swollen lymph nodes on the left side of my neck and left shoulder; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old male patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 22Apr2021 14:15 (Batch/Lot Number: EW0151) at single dose for COVID-19 immunization. Medical history included known allergies shellfish and tree nuts and he might be allergic to iodine, asthma, high blood pressure, acid reflux. Concomitant medications included finasteride (PROPECIA), cetirizine hydrochloride (ZYRTEC R), metoprolol, lisinopril, pantoprazole sodium sesquihydrate (PANTOPROL), all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 31Mar2021 14:00 (Batch/Lot Number: EI28733) at single dose for COVID-19 immunization. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Allergic reaction within 5 minutes (also reported as 22Apr2021 14:30) of the dose. Rushed to ER and given an IV of steroids, antihistamines, and another drug he can't remember. The patient on week #2 and still had massively swollen lymph nodes on the left side of his neck and left shoulder.  Dr. prescribed additional steroids (second regimen since the reaction) and antibiotics.  The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event included An IV of Antihistamines, steroids, etc. Facility where the most recent COVID-19 vaccine was administered was Hospital. The outcome of the events was recovering.    Information on Lot/Batch number was available. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity, Lymphadenopathy
Clinical narrative: Allergic reaction; still have massively swollen lymph nodes on the left side of my neck and left shoulder; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old male patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 22Apr2021 14:15 (Batch/Lot Number: EW0151) at single dose for COVID-19 immunization. Medical history included known allergies shellfish and tree nuts and he might be allergic to iodine, asthma, high blood pressure, acid reflux. Concomitant medications included finasteride (PROPECIA), cetirizine hydrochloride (ZYRTEC R), metoprolol, lisinopril, pantoprazole sodium sesquihydrate (PANTOPROL), all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 31Mar2021 14:00 (Batch/Lot Number: EI28733) at single dose for COVID-19 immunization. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Allergic reaction within 5 minutes (also reported as 22Apr2021 14:30) of the dose. Rushed to ER and given an IV of steroids, antihistamines, and another drug he can't remember. The patient on week #2 and still had massively swollen lymph nodes on the left side of his neck and left shoulder.  Dr. prescribed additional steroids (second regimen since the reaction) and antibiotics.  The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event included An IV of Antihistamines, steroids, etc. Facility where the most recent COVID-19 vaccine was administered was Hospital. The outcome of the events was recovering.    Information on Lot/Batch number was available. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Hypersomnia
Clinical narrative: beginning on 05/04/21 developed severe and disabling polymyalgia and poly arthralgia : was seen at urgent care twice and a local er once. we all agree this is likely an autoimmune inflammatory response to the vaccine. the patient has been placed on steroids with good response and pain reduction.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Motor dysfunction, Musculoskeletal stiffness, Pain, Peripheral swelling, SARS-CoV-2 test negative
Clinical narrative: beginning on 05/04/21 developed severe and disabling polymyalgia and poly arthralgia : was seen at urgent care twice and a local er once. we all agree this is likely an autoimmune inflammatory response to the vaccine. the patient has been placed on steroids with good response and pain reduction.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Full blood count, Inflammation, Metabolic function test, Myalgia
Clinical narrative: beginning on 05/04/21 developed severe and disabling polymyalgia and poly arthralgia : was seen at urgent care twice and a local er once. we all agree this is likely an autoimmune inflammatory response to the vaccine. the patient has been placed on steroids with good response and pain reduction.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: beginning on 05/04/21 developed severe and disabling polymyalgia and poly arthralgia : was seen at urgent care twice and a local er once. we all agree this is likely an autoimmune inflammatory response to the vaccine. the patient has been placed on steroids with good response and pain reduction.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Flushing, Hypertension, Nausea
Clinical narrative: Patient has history of allergic reaction to flu vaccine that was not disclosed at the time of vaccination.  patient had premedicated with pepcid and benadryl prior to vaccination.   Developed an itchy throat while in the vaccine clinic after vaccination
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Throat irritation, Throat tightness
Clinical narrative: Patient has history of allergic reaction to flu vaccine that was not disclosed at the time of vaccination.  patient had premedicated with pepcid and benadryl prior to vaccination.   Developed an itchy throat while in the vaccine clinic after vaccination
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Patient has history of allergic reaction to flu vaccine that was not disclosed at the time of vaccination.  patient had premedicated with pepcid and benadryl prior to vaccination.   Developed an itchy throat while in the vaccine clinic after vaccination
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: huge blood clot in her neck and a huge one in her left arm; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received the second dose bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 07May2021 (received at 48-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included fibromyalgia, colon cancer/postchemo from 2018, APS (antiphospholipid syndrome), arthritis and allergy to sulfa drugs. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. She was not pregnant. Concomitant medication(s) included pregabalin (LYRICA) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; oxybutynin (OXYBUTYNIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VIT B12) taken for an unspecified indication, start and stop date were not reported. Past drug history included known allergies to naproxen and oxycodone. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EW0161), administered in Arm Right on 16Apr2021 12:00 for COVID-19 immunisation. The patient got her second dose of the Pfizer vaccine on Friday, 07May2021. By Monday evening, 10May2021, her arm had swollen up at the elbow and was red, painful and warm to the touch. After appointment she had on Tuesday, 11May2021, she went to the ER (emergency room) as it had gotten worse and confirmed she has a huge blood clot in her neck and a huge one in her left arm. She was put on permanent blood thinners after following up with my PCP (primary care physician). The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). As corrective treatment, the patient received Lovenox, Wafarin, Zarelto. Outcome of the events was recovered with sequelae on an unspecified date in May2021. The adverse events were assessed as life-threatening.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: huge blood clot in her neck and a huge one in her left arm; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received the second dose bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 07May2021 (received at 48-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included fibromyalgia, colon cancer/postchemo from 2018, APS (antiphospholipid syndrome), arthritis and allergy to sulfa drugs. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. She was not pregnant. Concomitant medication(s) included pregabalin (LYRICA) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; oxybutynin (OXYBUTYNIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VIT B12) taken for an unspecified indication, start and stop date were not reported. Past drug history included known allergies to naproxen and oxycodone. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EW0161), administered in Arm Right on 16Apr2021 12:00 for COVID-19 immunisation. The patient got her second dose of the Pfizer vaccine on Friday, 07May2021. By Monday evening, 10May2021, her arm had swollen up at the elbow and was red, painful and warm to the touch. After appointment she had on Tuesday, 11May2021, she went to the ER (emergency room) as it had gotten worse and confirmed she has a huge blood clot in her neck and a huge one in her left arm. She was put on permanent blood thinners after following up with my PCP (primary care physician). The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). As corrective treatment, the patient received Lovenox, Wafarin, Zarelto. Outcome of the events was recovered with sequelae on an unspecified date in May2021. The adverse events were assessed as life-threatening.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: huge blood clot in her neck and a huge one in her left arm; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received the second dose bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 07May2021 (received at 48-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included fibromyalgia, colon cancer/postchemo from 2018, APS (antiphospholipid syndrome), arthritis and allergy to sulfa drugs. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. She was not pregnant. Concomitant medication(s) included pregabalin (LYRICA) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; oxybutynin (OXYBUTYNIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VIT B12) taken for an unspecified indication, start and stop date were not reported. Past drug history included known allergies to naproxen and oxycodone. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EW0161), administered in Arm Right on 16Apr2021 12:00 for COVID-19 immunisation. The patient got her second dose of the Pfizer vaccine on Friday, 07May2021. By Monday evening, 10May2021, her arm had swollen up at the elbow and was red, painful and warm to the touch. After appointment she had on Tuesday, 11May2021, she went to the ER (emergency room) as it had gotten worse and confirmed she has a huge blood clot in her neck and a huge one in her left arm. She was put on permanent blood thinners after following up with my PCP (primary care physician). The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). As corrective treatment, the patient received Lovenox, Wafarin, Zarelto. Outcome of the events was recovered with sequelae on an unspecified date in May2021. The adverse events were assessed as life-threatening.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: Patient presented to PCP office 5/17/2021 for intermittent SOB, pain with breathing, and acute pain to left lower calf. Calf pain began 5/16/2021. SOB had been intermittent and ongoing since after receiving 2nd COVID vaccine per patient. He was dx with acute DVT of LLE. Chest CT was not performed to evaluate for PE as patient reported improvement with SOB/breathing over the prior few days. He was started on Xarelto for blood clot. Blood clot was unprovoked, no prior history of clots/bleeding disorders. He is a generally healthy and active 51 year old male. Unclear if there is a correlation between recent COVID vaccination.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray abnormal, Deep vein thrombosis, Dyspnoea, Full blood count normal, International normalised ratio normal
Clinical narrative: Patient presented to PCP office 5/17/2021 for intermittent SOB, pain with breathing, and acute pain to left lower calf. Calf pain began 5/16/2021. SOB had been intermittent and ongoing since after receiving 2nd COVID vaccine per patient. He was dx with acute DVT of LLE. Chest CT was not performed to evaluate for PE as patient reported improvement with SOB/breathing over the prior few days. He was started on Xarelto for blood clot. Blood clot was unprovoked, no prior history of clots/bleeding disorders. He is a generally healthy and active 51 year old male. Unclear if there is a correlation between recent COVID vaccination.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Painful respiration, Prothrombin time normal
Clinical narrative: Patient presented to PCP office 5/17/2021 for intermittent SOB, pain with breathing, and acute pain to left lower calf. Calf pain began 5/16/2021. SOB had been intermittent and ongoing since after receiving 2nd COVID vaccine per patient. He was dx with acute DVT of LLE. Chest CT was not performed to evaluate for PE as patient reported improvement with SOB/breathing over the prior few days. He was started on Xarelto for blood clot. Blood clot was unprovoked, no prior history of clots/bleeding disorders. He is a generally healthy and active 51 year old male. Unclear if there is a correlation between recent COVID vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chills, Dizziness postural, Dysarthria, Fall
Clinical narrative: Pt experienced intense chills and arm soreness on Saturday afternoon, the day after the vaccine.  Pt fell and fainted for a few seconds while going to the bathroom. Pt experienced slurred speech, fuzzy vision, and hearing loss for about 5 minutes after regaining consciousness. Ambulance took pt to .
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hypoacusis, Loss of consciousness, Pain, Somnolence
Clinical narrative: Pt experienced intense chills and arm soreness on Saturday afternoon, the day after the vaccine.  Pt fell and fainted for a few seconds while going to the bathroom. Pt experienced slurred speech, fuzzy vision, and hearing loss for about 5 minutes after regaining consciousness. Ambulance took pt to .
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Pt experienced intense chills and arm soreness on Saturday afternoon, the day after the vaccine.  Pt fell and fainted for a few seconds while going to the bathroom. Pt experienced slurred speech, fuzzy vision, and hearing loss for about 5 minutes after regaining consciousness. Ambulance took pt to .
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Deafness, Dysarthria, Fall, Laboratory test normal
Clinical narrative: Pt experienced intense chills and arm soreness on Saturday afternoon, the day after the vaccine.  Pt fell and fainted for a few seconds while going to the bathroom. Pt experienced slurred speech, fuzzy vision, and hearing loss for about 5 minutes after regaining consciousness. Ambulance took pt to .
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Syncope, Vision blurred
Clinical narrative: Pt experienced intense chills and arm soreness on Saturday afternoon, the day after the vaccine.  Pt fell and fainted for a few seconds while going to the bathroom. Pt experienced slurred speech, fuzzy vision, and hearing loss for about 5 minutes after regaining consciousness. Ambulance took pt to .
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test, Chest X-ray, Computerised tomogram, Echocardiogram
Clinical narrative: multiple pulmonary embolisms in both lungs; Lung infarction occurred in left lung; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 27Apr2021 at 08:00 AM at 30 years (Lot# EW0169) as single dose, for COVID-19 immunisation. The patient was not pregnant and was not pregnant at time of vaccination. Medical history was none. Patient had no known allergies. It was unknown if patient experienced COVID-19 prior to vaccination. Concomitant medication in two weeks included multivitamin. The patient did not receive any other vaccine in four weeks. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation on 06Apr2021 at 01:30 PM in left arm (Lot# ER8734) at 30 years. The patient experienced multiple pulmonary embolisms in both lungs (caused hospitalization, life threatening) on 04May2021 at 03:00 PM with outcome of recovering, lung infarction occurred in left lung (caused hospitalization, life threatening) on 04May2021 at 03:00 PM with outcome of recovering. The patient was hospitalized from 05May2021 to 08May2021. The events also required emergency room visit. Patient was tested for COVID-19 post vaccination (nasal swab): negative on 05May2021. Therapeutic measures were taken as a result of the events and included treatment with Lovenox injections, pain management, oral blood thinner.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Pulmonary embolism, Pulmonary infarction, Ultrasound Doppler
Clinical narrative: multiple pulmonary embolisms in both lungs; Lung infarction occurred in left lung; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 27Apr2021 at 08:00 AM at 30 years (Lot# EW0169) as single dose, for COVID-19 immunisation. The patient was not pregnant and was not pregnant at time of vaccination. Medical history was none. Patient had no known allergies. It was unknown if patient experienced COVID-19 prior to vaccination. Concomitant medication in two weeks included multivitamin. The patient did not receive any other vaccine in four weeks. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation on 06Apr2021 at 01:30 PM in left arm (Lot# ER8734) at 30 years. The patient experienced multiple pulmonary embolisms in both lungs (caused hospitalization, life threatening) on 04May2021 at 03:00 PM with outcome of recovering, lung infarction occurred in left lung (caused hospitalization, life threatening) on 04May2021 at 03:00 PM with outcome of recovering. The patient was hospitalized from 05May2021 to 08May2021. The events also required emergency room visit. Patient was tested for COVID-19 post vaccination (nasal swab): negative on 05May2021. Therapeutic measures were taken as a result of the events and included treatment with Lovenox injections, pain management, oral blood thinner.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, Pulmonary infarction, SARS-CoV-2 test
Clinical narrative: multiple pulmonary embolisms in both lungs; Lung infarction occurred in left lung; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 27Apr2021 at 08:00 AM at 30 years (Lot# EW0169) as single dose, for COVID-19 immunisation. The patient was not pregnant and was not pregnant at time of vaccination. Medical history was none. Patient had no known allergies. It was unknown if patient experienced COVID-19 prior to vaccination. Concomitant medication in two weeks included multivitamin. The patient did not receive any other vaccine in four weeks. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation on 06Apr2021 at 01:30 PM in left arm (Lot# ER8734) at 30 years. The patient experienced multiple pulmonary embolisms in both lungs (caused hospitalization, life threatening) on 04May2021 at 03:00 PM with outcome of recovering, lung infarction occurred in left lung (caused hospitalization, life threatening) on 04May2021 at 03:00 PM with outcome of recovering. The patient was hospitalized from 05May2021 to 08May2021. The events also required emergency room visit. Patient was tested for COVID-19 post vaccination (nasal swab): negative on 05May2021. Therapeutic measures were taken as a result of the events and included treatment with Lovenox injections, pain management, oral blood thinner.