chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Respiratory distress, Speech disorder, Stress
Clinical narrative: in respiratory distress; Mild lightheaded; itchy; rash; severe headache; tightening in chest/tightness chest; voice increasing hoarse/decreased voice volume and able to say 2 words max; coughing; shortness of breath; very effortful to talk; Eyes droopy; tingling jaw, neck; stressful; Unable to do anything seconda; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP7534), via an unspecified route of administration at Arm Left on 24Mar2021 08:30 (at age of 55 years old) at single dose for COVID-19 immunization. Medical history included Type1 diabetes, allergies, Shellfish allergy. Concomitant medication included insulin lispro (HUMALOG); pravastatin sodium (PRAVASTATIN +PHARMA); cetirizine hydrochloride (ZYRTEC ALLERGY). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:30 AM, the patient experienced mild lightheaded first 1/2, by 90mins post skin itchy with rash just under skin, severe headache, tightening in chest, voice increasing hoarse, coughing, shortness of breath, decreased voice volume and able to say 2 words max, no observed swelling but in respiratory distress. Went to AMC Umergent care, epipen + benedryl +steroids administered, transferred to AMC hospital via ambulance. Monitored, IV fluids+ Pepcid, stabilized d/c home on 50mg prednisone + Pepcid. Symptoms (milder)reoccur in Wednesday pm, Thursday AM, Thursday PM following Pepcid. Friday Mild coughing during the day, but overall good energy, activity level, almost back to normal. 1/2 hour prior to prednisone 4:30 pm starting experiencing respiratory symptoms again. Vitals all stable, but very effortful to talk, exhale (coughing). Eyes droopy, tingling jaw, neck, tightness chest. Overall took 1.5 hours post prednisone for symptoms to improve and voice to return to almost normal. Very stressful. Unable to do anything seconda. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment (EPINEPHRINE, BENEDRYL, PEPCID, PREDNISONE) received for AE. The outcome of the events was unknown.  Information on the lot/batch number has been provided. Other information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Chest X-ray, Chills, Computerised tomogram
Clinical narrative: Weakness; dizziness; cold; seizure; This is a spontaneous report from a contactable consumer reporting for himself. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 10:45 (Lot Number: EN6205) as single dose for COVID-19 immunisation. Medical history included Heart stent. There were no known allergies to medications, food, or other products. Concomitant medications included atorvastatin; cyanocobalamine; loratadine (LORADINE); metoprolol, all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Weakness, dizziness, cold, seizure on 22Mar2021 16:45.  The events resulted in Emergency room/department or urgent care and hospitalization. The patient was hospitalized for Weakness, dizziness, cold, seizure for 2 days. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test Nasal Swab post vaccination: negative on 25Mar2021. Therapeutic measures were taken as a result of events which included Anti seizure meds.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Magnetic resonance imaging, SARS-CoV-2 test negative, Seizure, Urine analysis
Clinical narrative: Weakness; dizziness; cold; seizure; This is a spontaneous report from a contactable consumer reporting for himself. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 10:45 (Lot Number: EN6205) as single dose for COVID-19 immunisation. Medical history included Heart stent. There were no known allergies to medications, food, or other products. Concomitant medications included atorvastatin; cyanocobalamine; loratadine (LORADINE); metoprolol, all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Weakness, dizziness, cold, seizure on 22Mar2021 16:45.  The events resulted in Emergency room/department or urgent care and hospitalization. The patient was hospitalized for Weakness, dizziness, cold, seizure for 2 days. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test Nasal Swab post vaccination: negative on 25Mar2021. Therapeutic measures were taken as a result of events which included Anti seizure meds.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Nasopharyngitis, SARS-CoV-2 test, Seizure
Clinical narrative: Weakness; dizziness; cold; seizure; This is a spontaneous report from a contactable consumer reporting for himself. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 10:45 (Lot Number: EN6205) as single dose for COVID-19 immunisation. Medical history included Heart stent. There were no known allergies to medications, food, or other products. Concomitant medications included atorvastatin; cyanocobalamine; loratadine (LORADINE); metoprolol, all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Weakness, dizziness, cold, seizure on 22Mar2021 16:45.  The events resulted in Emergency room/department or urgent care and hospitalization. The patient was hospitalized for Weakness, dizziness, cold, seizure for 2 days. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test Nasal Swab post vaccination: negative on 25Mar2021. Therapeutic measures were taken as a result of events which included Anti seizure meds.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Head injury, Memory impairment, Syncope, Viral test
Clinical narrative: fainting; nauseous; I hit my head and chin on the dresser; I hit my head and chin on the dresser; I hit my head and chin on the dresser/seven stitches in my chin; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ER8727) via an unspecified route of administration, administered in left arm on 25Mar2021 09:00 as single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant and no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included hair vitamins, and tru metabolism in which the patient received within 2 weeks of vaccination. The patient received first dose of bnt162b2 for Covid-19 immunization on 04Mar2021, 09:30. On 26Mar2021, the patient reported that she went to use the restroom around 0300 am as she was feeling nauseous. The next thing she remembered was being woken up on the floor of her bedroom by her husband.  As a result of fainting, she hit my head and chin on the dresser. This resulted in needing seven stitches in her chin. The events resulted in emergency room/department or urgent care and therapy included stitches, x-rays, EKG and urine test on an unspecified date with unknown results. Outcome of events was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: fainting; nauseous; I hit my head and chin on the dresser; I hit my head and chin on the dresser; I hit my head and chin on the dresser/seven stitches in my chin; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ER8727) via an unspecified route of administration, administered in left arm on 25Mar2021 09:00 as single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant and no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included hair vitamins, and tru metabolism in which the patient received within 2 weeks of vaccination. The patient received first dose of bnt162b2 for Covid-19 immunization on 04Mar2021, 09:30. On 26Mar2021, the patient reported that she went to use the restroom around 0300 am as she was feeling nauseous. The next thing she remembered was being woken up on the floor of her bedroom by her husband.  As a result of fainting, she hit my head and chin on the dresser. This resulted in needing seven stitches in her chin. The events resulted in emergency room/department or urgent care and therapy included stitches, x-rays, EKG and urine test on an unspecified date with unknown results. Outcome of events was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Face injury, Head injury, Nausea, Syncope
Clinical narrative: fainting; nauseous; I hit my head and chin on the dresser; I hit my head and chin on the dresser; I hit my head and chin on the dresser/seven stitches in my chin; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ER8727) via an unspecified route of administration, administered in left arm on 25Mar2021 09:00 as single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant and no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included hair vitamins, and tru metabolism in which the patient received within 2 weeks of vaccination. The patient received first dose of bnt162b2 for Covid-19 immunization on 04Mar2021, 09:30. On 26Mar2021, the patient reported that she went to use the restroom around 0300 am as she was feeling nauseous. The next thing she remembered was being woken up on the floor of her bedroom by her husband.  As a result of fainting, she hit my head and chin on the dresser. This resulted in needing seven stitches in her chin. The events resulted in emergency room/department or urgent care and therapy included stitches, x-rays, EKG and urine test on an unspecified date with unknown results. Outcome of events was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis, Wound, X-ray
Clinical narrative: fainting; nauseous; I hit my head and chin on the dresser; I hit my head and chin on the dresser; I hit my head and chin on the dresser/seven stitches in my chin; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ER8727) via an unspecified route of administration, administered in left arm on 25Mar2021 09:00 as single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant and no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included hair vitamins, and tru metabolism in which the patient received within 2 weeks of vaccination. The patient received first dose of bnt162b2 for Covid-19 immunization on 04Mar2021, 09:30. On 26Mar2021, the patient reported that she went to use the restroom around 0300 am as she was feeling nauseous. The next thing she remembered was being woken up on the floor of her bedroom by her husband.  As a result of fainting, she hit my head and chin on the dresser. This resulted in needing seven stitches in her chin. The events resulted in emergency room/department or urgent care and therapy included stitches, x-rays, EKG and urine test on an unspecified date with unknown results. Outcome of events was recovering.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Bell's palsy, Blood test, Deafness, Ear infection
Clinical narrative: nausea; Zoster (shingles) infection of the ear causing the facial paralysis and vertigo was diagnosed, also known as Ramsay Hunt Syndrome; Swelling of ear; pain intensified; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6199 and expiration date: Not available), via an unspecified route of administration in the left arm on 08Mar2021 at 08:30 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had possible Sulfa's allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. No COVID-19 test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 10Mar2021 at 14:00, the patient experienced pain in ear began two days after vaccine. Swelling of ear, pain intensified, facial paralysis occurred within 6 days from vaccine. Vertigo and nausea set in 7 days after vaccine. Zoster (shingles) infection of the ear causing the facial paralysis and vertigo was diagnosed, also known as Ramsay Hunt Syndrome. 19 days post vaccine and no improvement. The patient still continuing treatment with prescribed medications. The events resulted in a visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The clinical outcome of events was not recovered.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Ear swelling, Erythema, Facial pain, Facial paralysis
Clinical narrative: nausea; Zoster (shingles) infection of the ear causing the facial paralysis and vertigo was diagnosed, also known as Ramsay Hunt Syndrome; Swelling of ear; pain intensified; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6199 and expiration date: Not available), via an unspecified route of administration in the left arm on 08Mar2021 at 08:30 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had possible Sulfa's allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. No COVID-19 test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 10Mar2021 at 14:00, the patient experienced pain in ear began two days after vaccine. Swelling of ear, pain intensified, facial paralysis occurred within 6 days from vaccine. Vertigo and nausea set in 7 days after vaccine. Zoster (shingles) infection of the ear causing the facial paralysis and vertigo was diagnosed, also known as Ramsay Hunt Syndrome. 19 days post vaccine and no improvement. The patient still continuing treatment with prescribed medications. The events resulted in a visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The clinical outcome of events was not recovered.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Herpes zoster oticus, Lymph node pain, Magnetic resonance imaging, Nausea
Clinical narrative: nausea; Zoster (shingles) infection of the ear causing the facial paralysis and vertigo was diagnosed, also known as Ramsay Hunt Syndrome; Swelling of ear; pain intensified; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6199 and expiration date: Not available), via an unspecified route of administration in the left arm on 08Mar2021 at 08:30 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had possible Sulfa's allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. No COVID-19 test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 10Mar2021 at 14:00, the patient experienced pain in ear began two days after vaccine. Swelling of ear, pain intensified, facial paralysis occurred within 6 days from vaccine. Vertigo and nausea set in 7 days after vaccine. Zoster (shingles) infection of the ear causing the facial paralysis and vertigo was diagnosed, also known as Ramsay Hunt Syndrome. 19 days post vaccine and no improvement. The patient still continuing treatment with prescribed medications. The events resulted in a visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The clinical outcome of events was not recovered.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication, Vertigo
Clinical narrative: nausea; Zoster (shingles) infection of the ear causing the facial paralysis and vertigo was diagnosed, also known as Ramsay Hunt Syndrome; Swelling of ear; pain intensified; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6199 and expiration date: Not available), via an unspecified route of administration in the left arm on 08Mar2021 at 08:30 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had possible Sulfa's allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. No COVID-19 test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 10Mar2021 at 14:00, the patient experienced pain in ear began two days after vaccine. Swelling of ear, pain intensified, facial paralysis occurred within 6 days from vaccine. Vertigo and nausea set in 7 days after vaccine. Zoster (shingles) infection of the ear causing the facial paralysis and vertigo was diagnosed, also known as Ramsay Hunt Syndrome. 19 days post vaccine and no improvement. The patient still continuing treatment with prescribed medications. The events resulted in a visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The clinical outcome of events was not recovered.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear swelling, Herpes zoster oticus, Nausea, Pain
Clinical narrative: nausea; Zoster (shingles) infection of the ear causing the facial paralysis and vertigo was diagnosed, also known as Ramsay Hunt Syndrome; Swelling of ear; pain intensified; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6199 and expiration date: Not available), via an unspecified route of administration in the left arm on 08Mar2021 at 08:30 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had possible Sulfa's allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. No COVID-19 test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 10Mar2021 at 14:00, the patient experienced pain in ear began two days after vaccine. Swelling of ear, pain intensified, facial paralysis occurred within 6 days from vaccine. Vertigo and nausea set in 7 days after vaccine. Zoster (shingles) infection of the ear causing the facial paralysis and vertigo was diagnosed, also known as Ramsay Hunt Syndrome. 19 days post vaccine and no improvement. The patient still continuing treatment with prescribed medications. The events resulted in a visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The clinical outcome of events was not recovered.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: injection site pain; joint pain; headache; dizziness; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm Left on 25Mar2021 09:30 (Lot Number: EN6207) as single dose for covid-19 immunization. Medical history included overweight. There were no concomitant medications. The patient did not receive other medications within 2 weeks of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced injection site pain, joint pain, headache, dizziness on 27Mar2021 12:00. No treatment received for the events. The report was non-serious. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Headache, Vaccination site pain
Clinical narrative: injection site pain; joint pain; headache; dizziness; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm Left on 25Mar2021 09:30 (Lot Number: EN6207) as single dose for covid-19 immunization. Medical history included overweight. There were no concomitant medications. The patient did not receive other medications within 2 weeks of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced injection site pain, joint pain, headache, dizziness on 27Mar2021 12:00. No treatment received for the events. The report was non-serious. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Swelling face, Swelling of eyelid, Urticaria
Clinical narrative: Right side of face swollen so the eye was almost invisible; rash on face, neck and hands, some on the upper right back; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955, expiry date: unknown), via an unspecified route of administration in the right arm, on 19Mar2021 08:30, as single dose, for COVID-19 immunisation. Medical history included Alpha gal (allergic to all mammal protein). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide; pravastatin sodium (PRAVASTINE); famotidine (PEPCID AC); and loratadine, all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6200, expiry date: unknown), via an unspecified route of administration in the left arm, on 22Feb2021 08:45, as single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 19Mar2021 at 12:30, the patient experienced right side of face swollen so the eye was almost invisible, rash on face, neck and hands, some on the upper right back. The events resulted to emergency room visit. Treatment included prednisone and Benadryl. The patient was recovering from the events.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Right side of face swollen so the eye was almost invisible; rash on face, neck and hands, some on the upper right back; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955, expiry date: unknown), via an unspecified route of administration in the right arm, on 19Mar2021 08:30, as single dose, for COVID-19 immunisation. Medical history included Alpha gal (allergic to all mammal protein). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide; pravastatin sodium (PRAVASTINE); famotidine (PEPCID AC); and loratadine, all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6200, expiry date: unknown), via an unspecified route of administration in the left arm, on 22Feb2021 08:45, as single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 19Mar2021 at 12:30, the patient experienced right side of face swollen so the eye was almost invisible, rash on face, neck and hands, some on the upper right back. The events resulted to emergency room visit. Treatment included prednisone and Benadryl. The patient was recovering from the events.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Bell's palsy, Facial paralysis
Clinical narrative: The symptoms were moving from my jaw to my cheek and impacting my vision; feeling feverish accompanied with body aches; feeling feverish accompanied with body aches; Moderate (level 3) case of Bell's Palsy/I began to feel more intense symptoms in my face, losing the ability to move/control muscles in the right side of my face; Fatigue; a stiff jaw/slight discomfort in my jaw; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 24Mar2021 09:45 (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included indapamide, and fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number: EL3248) on 04Mar2021 11:45 AM on left arm for COVID-19 immunization. The patient reported that on 24Mar2021 he received his 2nd dose of COVID 19 vaccine. On 25Mar2021 he woke up at 6:30am with fatigue and a stiff jaw. At around 2pm he began feeling feverish accompanied with body aches and it continued until 3:30am of 26Mar2021. During that time, he did not notice any face or jaw discomfort. On 26Mar2021 and 27Mar2021 he had little to no symptoms other than slight discomfort in his jaw. On 28Mar2021 he began to feel more intense symptoms in his face, losing the ability to move/control muscles in the right side of face. The symptoms were moving from his jaw to my cheek and impacting his vision. He reported that this was out of the norm, and it prompted him to contact his healthcare provider. On 29Mar2021 at 1:40, he sought care from his healthcare provider. After a full examination he determined that he had a moderate (level 3) case of Bell's Palsy (reported started on 25Mar2021 07:00). Bell's palsy resulted in Doctor or other healthcare professional office/clinic visit. He was prescribed 80 MG/day of Prednisone for 7 days. The patient has not recovered from the events at time of report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Fatigue, Joint stiffness, Pain, Pyrexia
Clinical narrative: The symptoms were moving from my jaw to my cheek and impacting my vision; feeling feverish accompanied with body aches; feeling feverish accompanied with body aches; Moderate (level 3) case of Bell's Palsy/I began to feel more intense symptoms in my face, losing the ability to move/control muscles in the right side of my face; Fatigue; a stiff jaw/slight discomfort in my jaw; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 24Mar2021 09:45 (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included indapamide, and fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number: EL3248) on 04Mar2021 11:45 AM on left arm for COVID-19 immunization. The patient reported that on 24Mar2021 he received his 2nd dose of COVID 19 vaccine. On 25Mar2021 he woke up at 6:30am with fatigue and a stiff jaw. At around 2pm he began feeling feverish accompanied with body aches and it continued until 3:30am of 26Mar2021. During that time, he did not notice any face or jaw discomfort. On 26Mar2021 and 27Mar2021 he had little to no symptoms other than slight discomfort in his jaw. On 28Mar2021 he began to feel more intense symptoms in his face, losing the ability to move/control muscles in the right side of face. The symptoms were moving from his jaw to my cheek and impacting his vision. He reported that this was out of the norm, and it prompted him to contact his healthcare provider. On 29Mar2021 at 1:40, he sought care from his healthcare provider. After a full examination he determined that he had a moderate (level 3) case of Bell's Palsy (reported started on 25Mar2021 07:00). Bell's palsy resulted in Doctor or other healthcare professional office/clinic visit. He was prescribed 80 MG/day of Prednisone for 7 days. The patient has not recovered from the events at time of report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: The symptoms were moving from my jaw to my cheek and impacting my vision; feeling feverish accompanied with body aches; feeling feverish accompanied with body aches; Moderate (level 3) case of Bell's Palsy/I began to feel more intense symptoms in my face, losing the ability to move/control muscles in the right side of my face; Fatigue; a stiff jaw/slight discomfort in my jaw; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 24Mar2021 09:45 (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included indapamide, and fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number: EL3248) on 04Mar2021 11:45 AM on left arm for COVID-19 immunization. The patient reported that on 24Mar2021 he received his 2nd dose of COVID 19 vaccine. On 25Mar2021 he woke up at 6:30am with fatigue and a stiff jaw. At around 2pm he began feeling feverish accompanied with body aches and it continued until 3:30am of 26Mar2021. During that time, he did not notice any face or jaw discomfort. On 26Mar2021 and 27Mar2021 he had little to no symptoms other than slight discomfort in his jaw. On 28Mar2021 he began to feel more intense symptoms in his face, losing the ability to move/control muscles in the right side of face. The symptoms were moving from his jaw to my cheek and impacting his vision. He reported that this was out of the norm, and it prompted him to contact his healthcare provider. On 29Mar2021 at 1:40, he sought care from his healthcare provider. After a full examination he determined that he had a moderate (level 3) case of Bell's Palsy (reported started on 25Mar2021 07:00). Bell's palsy resulted in Doctor or other healthcare professional office/clinic visit. He was prescribed 80 MG/day of Prednisone for 7 days. The patient has not recovered from the events at time of report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: The symptoms were moving from my jaw to my cheek and impacting my vision; feeling feverish accompanied with body aches; feeling feverish accompanied with body aches; Moderate (level 3) case of Bell's Palsy/I began to feel more intense symptoms in my face, losing the ability to move/control muscles in the right side of my face; Fatigue; a stiff jaw/slight discomfort in my jaw; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 24Mar2021 09:45 (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included indapamide, and fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number: EL3248) on 04Mar2021 11:45 AM on left arm for COVID-19 immunization. The patient reported that on 24Mar2021 he received his 2nd dose of COVID 19 vaccine. On 25Mar2021 he woke up at 6:30am with fatigue and a stiff jaw. At around 2pm he began feeling feverish accompanied with body aches and it continued until 3:30am of 26Mar2021. During that time, he did not notice any face or jaw discomfort. On 26Mar2021 and 27Mar2021 he had little to no symptoms other than slight discomfort in his jaw. On 28Mar2021 he began to feel more intense symptoms in his face, losing the ability to move/control muscles in the right side of face. The symptoms were moving from his jaw to my cheek and impacting his vision. He reported that this was out of the norm, and it prompted him to contact his healthcare provider. On 29Mar2021 at 1:40, he sought care from his healthcare provider. After a full examination he determined that he had a moderate (level 3) case of Bell's Palsy (reported started on 25Mar2021 07:00). Bell's palsy resulted in Doctor or other healthcare professional office/clinic visit. He was prescribed 80 MG/day of Prednisone for 7 days. The patient has not recovered from the events at time of report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Renal infarct
Clinical narrative: INFARCTION OF LOWER RIGHT KIDNEY VESSEL/FLANK PAIN; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 44 year old male. 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: Unknown) dose was not reported, frequency once total, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 25-MAR-2021, 2.5 weeks after the vaccine. the patient experienced flank pain (subsumed and coded as infarction of lower right kidney vessel), headache and fatigue. Patient went to urgent care and was released with antibiotics. Symptoms got escalated and patient went to emergency room on 26-MAR-2021 (the following day). Patient was admitted to hospital on 26-Mar-2021 and spent 4 nights in the hospital. Patient was diagnosed with an infarction of lower right kidney vessel. Patient was discharged on 30-Mar-2021. Patient was hospitalized for 4 days. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fatigue, and infarction of lower right kidney vessel. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210407248-covid-19 vaccine ad26.cov2.s - infarction of lower right kidney vessel/flank pain. This event(s) is considered unassessable. The event(s) 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(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Renal infarct
Clinical narrative: INFARCTION OF LOWER RIGHT KIDNEY VESSEL/FLANK PAIN; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 44 year old male. 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: Unknown) dose was not reported, frequency once total, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 25-MAR-2021, 2.5 weeks after the vaccine. the patient experienced flank pain (subsumed and coded as infarction of lower right kidney vessel), headache and fatigue. Patient went to urgent care and was released with antibiotics. Symptoms got escalated and patient went to emergency room on 26-MAR-2021 (the following day). Patient was admitted to hospital on 26-Mar-2021 and spent 4 nights in the hospital. Patient was diagnosed with an infarction of lower right kidney vessel. Patient was discharged on 30-Mar-2021. Patient was hospitalized for 4 days. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fatigue, and infarction of lower right kidney vessel. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210407248-covid-19 vaccine ad26.cov2.s - infarction of lower right kidney vessel/flank pain. This event(s) is considered unassessable. The event(s) 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(s).
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperacusis, Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL9261) via an unspecified route of administration to Left arm on 27Jan2021 18:45 at single dose for COVID-19 immunization. Patient medical history was not provided. Concomitant medications included chondroitin sulfate sodium, glucosamine sulfate potassium chloride, methylsulfonylmethane (GLUCOSAMINE & CHONDROITIN & MSM) and acetylcysteine (NAC). On 28Jan2021 08:00 patient reported with Increased volume with his tinnitus. The patient did not receive any treatment for the event. Outcome of event was not recovered.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL9261) via an unspecified route of administration to Left arm on 27Jan2021 18:45 at single dose for COVID-19 immunization. Patient medical history was not provided. Concomitant medications included chondroitin sulfate sodium, glucosamine sulfate potassium chloride, methylsulfonylmethane (GLUCOSAMINE & CHONDROITIN & MSM) and acetylcysteine (NAC). On 28Jan2021 08:00 patient reported with Increased volume with his tinnitus. The patient did not receive any treatment for the event. Outcome of event was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Fatigue, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Even being fully vaccinated she did contract COVID and tested positive on 28Mar2021/ symptomatic with congestion, sore throat, runny nose and fatigue; Even being fully vaccinated she did contract COVID and tested positive on 28Mar2021/ symptomatic with congestion, sore throat, runny nose and fatigue; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (PFIZER COVID 19 VACCINE) the first dose (lot number: EJ1688) via an unspecified route of administration, administered on left arm on 21Dec2020 at the age of 35 years old at single dose and then the second dose (lot number: EL1283) via an unspecified route of administration on 11Jan2021 at the age of 35 years old at single dose both for COVID-19 immunization. Patient had no allergies to medications, food, or other products and no other medical history. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Patient's kids came down with COVID starting on 22Mar2021. Even patient was fully vaccinated, patient did contract COVID and tested positive on 28Mar2021. Patient had been symptomatic with congestion, sore throat, runny nose and fatigue. Adverse events start date was on 27Mar2021. Patient underwent lab tests which included Nasal Swab, PCR on 28Mar2021, result was positive. No treatment received for the adverse event. Outcome of events was recovering.; Sender's Comments: Patient was fully vaccinated and contracted COVID -19 and tested positive on 28Mar2021.  Vaccination failure cannot be excluded, based on current information received.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Even being fully vaccinated she did contract COVID and tested positive on 28Mar2021/ symptomatic with congestion, sore throat, runny nose and fatigue; Even being fully vaccinated she did contract COVID and tested positive on 28Mar2021/ symptomatic with congestion, sore throat, runny nose and fatigue; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (PFIZER COVID 19 VACCINE) the first dose (lot number: EJ1688) via an unspecified route of administration, administered on left arm on 21Dec2020 at the age of 35 years old at single dose and then the second dose (lot number: EL1283) via an unspecified route of administration on 11Jan2021 at the age of 35 years old at single dose both for COVID-19 immunization. Patient had no allergies to medications, food, or other products and no other medical history. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Patient's kids came down with COVID starting on 22Mar2021. Even patient was fully vaccinated, patient did contract COVID and tested positive on 28Mar2021. Patient had been symptomatic with congestion, sore throat, runny nose and fatigue. Adverse events start date was on 27Mar2021. Patient underwent lab tests which included Nasal Swab, PCR on 28Mar2021, result was positive. No treatment received for the adverse event. Outcome of events was recovering.; Sender's Comments: Patient was fully vaccinated and contracted COVID -19 and tested positive on 28Mar2021.  Vaccination failure cannot be excluded, based on current information received.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: NASAL DRIP; MILD CONGESTION; INTENSE BODY ACHES; WEAKNESS BEHIND KNEES WORST ON LEFT SIDE; CHILLS; MEDIUM GRADE HEADACHE; FATIGUE; LOW GRADE FEVER; MUSCLE ACHE; NUMBNESS IN BOTH FEET - FRONTAL FROM BUNION OUTWARD MAINLY ON BOTTOM; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 150 pounds, and height was 180 centimeters. The patient's concurrent conditions included alcohol use, and nonsmoker, and other pre-existing medical conditions included the patient had no allergy to vaccine, drug, or food and no history of drug abuse. the patient had no illness at the time of vaccination, no past history of similar event, no adverse event after any previous vaccination, no family history of any disease or allergy relevant to vaccination and hospitalization in last 30 days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 on right arm muscle for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced numbness in both feet - frontal from bunion outward mainly on bottom. On 31-MAR-2021, the subject experienced intense body aches. On 31-MAR-2021, the subject experienced weakness behind knees worst on left side. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced medium grade headache. On 31-MAR-2021, the subject experienced fatigue. On 31-MAR-2021, the subject experienced low grade fever. On 31-MAR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nasal drip. On 01-APR-2021, the subject experienced mild congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 02-APR-2021, was recovering from medium grade headache, intense body aches, nasal drip, mild congestion, low grade fever, and muscle ache, had not recovered from numbness in both feet - frontal from bunion outward mainly on bottom, and weakness behind knees worst on left side, and the outcome of fatigue was not reported. This report was non-serious.