chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test negative, Pyrexia, Sinus tachycardia, Tachycardia
Clinical narrative: I received the COVID-19 Moderna second dose vaccine on May 5, 2021, at around 1 pm. The night after the vaccine, I had the typical side effects from the vaccine, which are chills, arm pain, severe fatigue, headache, slight fever. By the second day, chills were subsiding but I still feel very fatigued until the afternoon. Then by the third day, which was May 7, 2021, at around 2 am, I started feeling some chest tightness, which at first I associated with back pain.  However, as the day progresses, I started feeling short of breath, on and off chest pain, and palpitations. I decided to go to the ED around 10:15 pm, due to shortness of breath, and chest pain was more pronounced. Upon my arrival in the ED, I was tachycardic at 110. I was triaged and the ED physician ordered did blood work including D-Dimer, EKG. EKG reveals sinus tachycardia. The blood work reveals an elevated D-Dimer which was 1.06. And due to elevated dimer, the physician ordered a CT scan chest which was negative for PE. Since I was still having some shortness of breath and chest pain, I was admitted as observation, for telemetry monitoring and repeat EKG. The following day, I was discharged since the chest pain was resolving. However, I continued to have palpitations for at least a week after the vaccination. At that time, the ED physicians were not sure if my symptoms and elevated dimer were related to the vaccination. I followed up with a cardiologist and my PCP a few days after the hospitalization. I followed up with the cardiologists because of my history of pulmonary hypertension 5 years ago which I believe was resolved, however, it was a concern for the ED physician, because at the time they were not sure of what is the cause of my symptoms. During my visit with the cardiologists, he believed that my elevated dimer was due to the vaccination (possibly due to the inflammatory response), as well as the symptoms I have which was pericardial pain. I did my echo last week, and I will need to do another blood test this week, to check my dimer, and cardiac enzymes.   And now, since I had the vaccination, I have not had my period for 18 days, which is very uncommon to me. I had my period a few days after the vaccine. All my pregnancy tests are negative. So I am scheduled to follow up with my OB-GYN. I believe that my delayed period is also related to the vaccine, but of course, I cannot conclude that until I see my physician and conduct all the tests needed.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal, Muscular weakness
Clinical narrative: right upper extremlty weakness
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest discomfort, Chest pain, Echocardiogram abnormal, Inflammatory marker test
Clinical narrative: On May 2, 2021 patient started experiencing back and anterior chest discomfort extending up to throat, transiently relieved with NSAIDs (seen by primary provider on May 7, 2021). During our follow up on 5/12/21, she endorsed chest pain worse when lying down, better when sitting up; clinical symptoms appeared suggestive of pericarditis. CRP was elevated at 16 mg/L (normal laboratory rage 0-10 mg/L) sedimentation rate was within range at 20 mm/hr (normal laboratory range 0-32 mm/hr). Echocardiogram demonstrated a trace pericardial effusion. Patient was started on ibuprofen and colchicine. Follow p inflammatory markers demonstrated normalization of CRP (0.4 mg/dL - normal laboratory range </=0.9 mg/dL0; ESR was within range at 9 mm/hr (normal laboratory range 0-30 mm/hr). Ibuprofen was discontinued on June 15, 2021. She remains on colchicine. Symptoms improved following initiation of therapy, and she no longer has chest pain.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Oropharyngeal discomfort, Pericardial effusion, Pericarditis, Red blood cell sedimentation rate normal
Clinical narrative: On May 2, 2021 patient started experiencing back and anterior chest discomfort extending up to throat, transiently relieved with NSAIDs (seen by primary provider on May 7, 2021). During our follow up on 5/12/21, she endorsed chest pain worse when lying down, better when sitting up; clinical symptoms appeared suggestive of pericarditis. CRP was elevated at 16 mg/L (normal laboratory rage 0-10 mg/L) sedimentation rate was within range at 20 mm/hr (normal laboratory range 0-32 mm/hr). Echocardiogram demonstrated a trace pericardial effusion. Patient was started on ibuprofen and colchicine. Follow p inflammatory markers demonstrated normalization of CRP (0.4 mg/dL - normal laboratory range </=0.9 mg/dL0; ESR was within range at 9 mm/hr (normal laboratory range 0-30 mm/hr). Ibuprofen was discontinued on June 15, 2021. She remains on colchicine. Symptoms improved following initiation of therapy, and she no longer has chest pain.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac imaging procedure abnormal, Catheterisation cardiac, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: 2nd Covid dose given at 1000hrs on 16Jun2021. On 17Jun2021, 1700hrs reported to Hospital ER with c/o substernal chest tightness/pressure, +SOB. Was discharged from ER stable and referred to Primary care provider listed above. On 18Jun2021, pt had recurring chest pain/tightness symptoms and returned to ER. Pt was noted to have positive Troponins with symptoms and was transferred by EMS to Hospital. He was admitted to the Cardiology service where subsequently he received a Cardiac Catherization and a Cardiac MRI. Pt was admitted for 2 days; discharged on 20Jun2021 with Dx: Myocarditis. Pt to follow up with Cardiology.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Myocarditis, Troponin increased, Ventricular hypertrophy
Clinical narrative: 2nd Covid dose given at 1000hrs on 16Jun2021. On 17Jun2021, 1700hrs reported to Hospital ER with c/o substernal chest tightness/pressure, +SOB. Was discharged from ER stable and referred to Primary care provider listed above. On 18Jun2021, pt had recurring chest pain/tightness symptoms and returned to ER. Pt was noted to have positive Troponins with symptoms and was transferred by EMS to Hospital. He was admitted to the Cardiology service where subsequently he received a Cardiac Catherization and a Cardiac MRI. Pt was admitted for 2 days; discharged on 20Jun2021 with Dx: Myocarditis. Pt to follow up with Cardiology.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient scheduled for COVID- 19 vaccine in error for 2nd dose however not due until 7/6/2021. 2nd dose administered after 2 weeks versus 3 weeks, 3 days prior to 4 - day grace period. No adverse effects noted thus far.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hypoacusis, Hypoaesthesia, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Patient stated at time of vaccination that she does sometimes get dizzy and faint during vaccines. After administration, she said she felt fine & sat near pharmacy. I went to give her a record card & noticed she didn't look well. I asked her if she felt ok; she said she felt very dizzy & then passed out. I ran out and caught her. She was shaking a bit too kind of like a seizure. One tech called EMS & one tech helped me. She woke up & said she was fine and then passed out again Again woke up, then said felt her tongue swelling, I ran to get an EpiPen and pulled it out of the box. Before admin, pt said tongue swelling is better so didn't administer. She couldn't hear properly, numbness in hands/legs, & stiff hands.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Seizure, Swollen tongue, Tremor
Clinical narrative: Patient stated at time of vaccination that she does sometimes get dizzy and faint during vaccines. After administration, she said she felt fine & sat near pharmacy. I went to give her a record card & noticed she didn't look well. I asked her if she felt ok; she said she felt very dizzy & then passed out. I ran out and caught her. She was shaking a bit too kind of like a seizure. One tech called EMS & one tech helped me. She woke up & said she was fine and then passed out again Again woke up, then said felt her tongue swelling, I ran to get an EpiPen and pulled it out of the box. Before admin, pt said tongue swelling is better so didn't administer. She couldn't hear properly, numbness in hands/legs, & stiff hands.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Terminal state
Clinical narrative: Pt expired Pt was on hospice for end of life cares and death was anticipated Pt was in long term care facility so vaccine was administered due to congregate living environment
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chest pain, Electrocardiogram, Feeling hot, Headache
Clinical narrative: Shortness of breath; GI upset; After about 15 Mins got a scratch rash on my arm that spread over the hour across my back and chest; Increased heart rate; Increased heart rate and blood pressure; This is a spontaneous report from a contactable other health care professional (nurse/patient).  A 44-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK5130) via intramuscular route of administration and administered in right arm on 23Dec2020 10:00 (at the age of 44 years old) as dose 1, single for COVID-19 immunization. The patient medical history include Hashimoto, insulin resistance and endometriosis. Concomitant medications in two weeks included metoprolol (METOPROLOL), lisdexamfetamine mesilate (VYVANSE), metformin (METFORMIN), probiotics nos (PROBIOTICS NOS), vitamin b complex (VIT B COMPLEX), ergocalciferol (VIT D), botulinum toxin type a (BOTOX) on unknown date in Oct2014, Amour Thyroid, Ashawanga and Juvaderm. The patient was allergic to IV Contrast, demerol, Omnicef, arnica, beets, wheat, fish oil, hydrocortisone and benzyl-peroxide. Reportedly, on 23Dec2020, 15 Min after vaccination patient got a scratch rash on my arm that spread over the hour across my back and chest, Increased heart rate and blood pressure. Shortness of breath and GI upset on 23Dec2020 at 10:30. The patient underwent lab tests and procedures which included blood test: positive on 04Feb2021, polymerase chain reaction: negative on 25May2020 Nasal Swab, polymerase chain reaction: negative on 02Jun2021 Nasal Swab, sars-cov-2 test (PCR Test result): negative on 06Jun2021 Nasal Swab. Therapeutic measures were taken as a result of events IVP (Pepcid, Benadryl, Prednisone) A litre of lactate ringers. The AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/Department or Urgent care. The patient did not had covid prior vaccination. The patient was tested for covid post vaccination. The outcome of events was recovered.  Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: The events of Dyspnoea, rash, heart rate increased, blood pressure increased and abdominal discomfort are assessed as  possibly related to the suspect drug BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient's medical history Hashimoto, insulin resistance . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Injection site pruritus, Pain in extremity
Clinical narrative: Shortness of breath; GI upset; After about 15 Mins got a scratch rash on my arm that spread over the hour across my back and chest; Increased heart rate; Increased heart rate and blood pressure; This is a spontaneous report from a contactable other health care professional (nurse/patient).  A 44-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK5130) via intramuscular route of administration and administered in right arm on 23Dec2020 10:00 (at the age of 44 years old) as dose 1, single for COVID-19 immunization. The patient medical history include Hashimoto, insulin resistance and endometriosis. Concomitant medications in two weeks included metoprolol (METOPROLOL), lisdexamfetamine mesilate (VYVANSE), metformin (METFORMIN), probiotics nos (PROBIOTICS NOS), vitamin b complex (VIT B COMPLEX), ergocalciferol (VIT D), botulinum toxin type a (BOTOX) on unknown date in Oct2014, Amour Thyroid, Ashawanga and Juvaderm. The patient was allergic to IV Contrast, demerol, Omnicef, arnica, beets, wheat, fish oil, hydrocortisone and benzyl-peroxide. Reportedly, on 23Dec2020, 15 Min after vaccination patient got a scratch rash on my arm that spread over the hour across my back and chest, Increased heart rate and blood pressure. Shortness of breath and GI upset on 23Dec2020 at 10:30. The patient underwent lab tests and procedures which included blood test: positive on 04Feb2021, polymerase chain reaction: negative on 25May2020 Nasal Swab, polymerase chain reaction: negative on 02Jun2021 Nasal Swab, sars-cov-2 test (PCR Test result): negative on 06Jun2021 Nasal Swab. Therapeutic measures were taken as a result of events IVP (Pepcid, Benadryl, Prednisone) A litre of lactate ringers. The AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/Department or Urgent care. The patient did not had covid prior vaccination. The patient was tested for covid post vaccination. The outcome of events was recovered.  Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: The events of Dyspnoea, rash, heart rate increased, blood pressure increased and abdominal discomfort are assessed as  possibly related to the suspect drug BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient's medical history Hashimoto, insulin resistance . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Blood pressure increased, Blood test, Dyspnoea, Heart rate increased
Clinical narrative: Shortness of breath; GI upset; After about 15 Mins got a scratch rash on my arm that spread over the hour across my back and chest; Increased heart rate; Increased heart rate and blood pressure; This is a spontaneous report from a contactable other health care professional (nurse/patient).  A 44-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK5130) via intramuscular route of administration and administered in right arm on 23Dec2020 10:00 (at the age of 44 years old) as dose 1, single for COVID-19 immunization. The patient medical history include Hashimoto, insulin resistance and endometriosis. Concomitant medications in two weeks included metoprolol (METOPROLOL), lisdexamfetamine mesilate (VYVANSE), metformin (METFORMIN), probiotics nos (PROBIOTICS NOS), vitamin b complex (VIT B COMPLEX), ergocalciferol (VIT D), botulinum toxin type a (BOTOX) on unknown date in Oct2014, Amour Thyroid, Ashawanga and Juvaderm. The patient was allergic to IV Contrast, demerol, Omnicef, arnica, beets, wheat, fish oil, hydrocortisone and benzyl-peroxide. Reportedly, on 23Dec2020, 15 Min after vaccination patient got a scratch rash on my arm that spread over the hour across my back and chest, Increased heart rate and blood pressure. Shortness of breath and GI upset on 23Dec2020 at 10:30. The patient underwent lab tests and procedures which included blood test: positive on 04Feb2021, polymerase chain reaction: negative on 25May2020 Nasal Swab, polymerase chain reaction: negative on 02Jun2021 Nasal Swab, sars-cov-2 test (PCR Test result): negative on 06Jun2021 Nasal Swab. Therapeutic measures were taken as a result of events IVP (Pepcid, Benadryl, Prednisone) A litre of lactate ringers. The AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/Department or Urgent care. The patient did not had covid prior vaccination. The patient was tested for covid post vaccination. The outcome of events was recovered.  Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: The events of Dyspnoea, rash, heart rate increased, blood pressure increased and abdominal discomfort are assessed as  possibly related to the suspect drug BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient's medical history Hashimoto, insulin resistance . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Polymerase chain reaction, Rash, SARS-CoV-2 test
Clinical narrative: Shortness of breath; GI upset; After about 15 Mins got a scratch rash on my arm that spread over the hour across my back and chest; Increased heart rate; Increased heart rate and blood pressure; This is a spontaneous report from a contactable other health care professional (nurse/patient).  A 44-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK5130) via intramuscular route of administration and administered in right arm on 23Dec2020 10:00 (at the age of 44 years old) as dose 1, single for COVID-19 immunization. The patient medical history include Hashimoto, insulin resistance and endometriosis. Concomitant medications in two weeks included metoprolol (METOPROLOL), lisdexamfetamine mesilate (VYVANSE), metformin (METFORMIN), probiotics nos (PROBIOTICS NOS), vitamin b complex (VIT B COMPLEX), ergocalciferol (VIT D), botulinum toxin type a (BOTOX) on unknown date in Oct2014, Amour Thyroid, Ashawanga and Juvaderm. The patient was allergic to IV Contrast, demerol, Omnicef, arnica, beets, wheat, fish oil, hydrocortisone and benzyl-peroxide. Reportedly, on 23Dec2020, 15 Min after vaccination patient got a scratch rash on my arm that spread over the hour across my back and chest, Increased heart rate and blood pressure. Shortness of breath and GI upset on 23Dec2020 at 10:30. The patient underwent lab tests and procedures which included blood test: positive on 04Feb2021, polymerase chain reaction: negative on 25May2020 Nasal Swab, polymerase chain reaction: negative on 02Jun2021 Nasal Swab, sars-cov-2 test (PCR Test result): negative on 06Jun2021 Nasal Swab. Therapeutic measures were taken as a result of events IVP (Pepcid, Benadryl, Prednisone) A litre of lactate ringers. The AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/Department or Urgent care. The patient did not had covid prior vaccination. The patient was tested for covid post vaccination. The outcome of events was recovered.  Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: The events of Dyspnoea, rash, heart rate increased, blood pressure increased and abdominal discomfort are assessed as  possibly related to the suspect drug BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient's medical history Hashimoto, insulin resistance . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Deafness, Magnetic resonance imaging
Clinical narrative: Lost full hearing in left ear/  lost hearing in left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Lost full hearing in left ear/  lost hearing in left ear) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced DEAFNESS UNILATERAL (Lost full hearing in left ear/  lost hearing in left ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Lost full hearing in left ear/  lost hearing in left ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  Treatment medication included oral steroids, injectable steroids into ear and also included unspecified Hearing tests.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral
Clinical narrative: Lost full hearing in left ear/  lost hearing in left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Lost full hearing in left ear/  lost hearing in left ear) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced DEAFNESS UNILATERAL (Lost full hearing in left ear/  lost hearing in left ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Lost full hearing in left ear/  lost hearing in left ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  Treatment medication included oral steroids, injectable steroids into ear and also included unspecified Hearing tests.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Rash pruritic, Skin warm
Clinical narrative: Hot; itchy rash all across clavicles,chest and partial neck; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9261) via an unspecified route of administration on 26-JAN-2021 at 14:30 hours on right arm as dose 1, single (at the age of 54-years-old) for COVID-19 immunization at Health Clinic. The medical history and concomitant medications were not reported. It was mentioned patient did not have any allergies to medications, food, or other products and not received any medications within 2 weeks of vaccination. Prior to vaccination, patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. On 04Feb2021 at 12:00 pm the patient experienced hot, itchy rash all across clavicles, chest and partial neck. Since the vaccination, patient has not been tested for COVID-19. The case was not considered serious and not resulted in death, and had no Life threatening, no Disabling/Incapacitating, not Caused/prolonged hospitalization and no Congenital anomaly/birth defect. No treatment was received for the events. The patient not recovered from events.   Follow-up attempts were completed. No further information was expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Rash pruritic
Clinical narrative: Hot; itchy rash all across clavicles,chest and partial neck; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9261) via an unspecified route of administration on 26-JAN-2021 at 14:30 hours on right arm as dose 1, single (at the age of 54-years-old) for COVID-19 immunization at Health Clinic. The medical history and concomitant medications were not reported. It was mentioned patient did not have any allergies to medications, food, or other products and not received any medications within 2 weeks of vaccination. Prior to vaccination, patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. On 04Feb2021 at 12:00 pm the patient experienced hot, itchy rash all across clavicles, chest and partial neck. Since the vaccination, patient has not been tested for COVID-19. The case was not considered serious and not resulted in death, and had no Life threatening, no Disabling/Incapacitating, not Caused/prolonged hospitalization and no Congenital anomaly/birth defect. No treatment was received for the events. The patient not recovered from events.   Follow-up attempts were completed. No further information was expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Back pain, Body temperature fluctuation, Insomnia
Clinical narrative: significant abdominal aches; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; Temperature range 96.2 to 100.8; night sweats; At times had hard time getting around, e.g. standing straight, bending, walking, getting into bed, moving around in bed; Sleep interrupted for 8 nights sometimes for long stretches; Pain moved around intense in one area and then 6, hours later, intense in another area; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL1283) via an unspecified route of administration in right arm on 26Jan2021 at 12:45 (age at vaccination 75-year-old) as dose 1, single for COVID-19 immunization. Patients medical history included osteoarthritis.  Patient was allergic to sulfa drugs. Patients concomitant medications included Calcium, Magnesium, Cranberry and Vitamin D NOS for supplement. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Jan at 15:00, patient experienced significant abdominal aches, pains in hip, pelvic areas as well as mid-spine to limbo-sacral areas. Temperature range 96.2 to 100.8, night sweats. At times had hard time getting around, example like standing straight, bending, walking, getting into bed, moving around in bed. Pain moved around intense in one area and then 6 hours later, intense in another area. Pain range 2 - 7 on scale of 0-10. Sleep interrupted for 8 nights sometimes for long stretches. Patient don't like taking medication, so only took one tylenol when temp got to 100.8. Never had this kind of reaction to a vaccination. Patient did not receive any treatment. The patient underwent lab tests and procedures which included body temperature:  96.2 100.8 (unit not provided) and pain assessment 2-7 on 30Jan2021. The outcome of events was recovered on 06Feb2021.   Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Night sweats, Pelvic pain
Clinical narrative: significant abdominal aches; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; Temperature range 96.2 to 100.8; night sweats; At times had hard time getting around, e.g. standing straight, bending, walking, getting into bed, moving around in bed; Sleep interrupted for 8 nights sometimes for long stretches; Pain moved around intense in one area and then 6, hours later, intense in another area; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL1283) via an unspecified route of administration in right arm on 26Jan2021 at 12:45 (age at vaccination 75-year-old) as dose 1, single for COVID-19 immunization. Patients medical history included osteoarthritis.  Patient was allergic to sulfa drugs. Patients concomitant medications included Calcium, Magnesium, Cranberry and Vitamin D NOS for supplement. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Jan at 15:00, patient experienced significant abdominal aches, pains in hip, pelvic areas as well as mid-spine to limbo-sacral areas. Temperature range 96.2 to 100.8, night sweats. At times had hard time getting around, example like standing straight, bending, walking, getting into bed, moving around in bed. Pain moved around intense in one area and then 6 hours later, intense in another area. Pain range 2 - 7 on scale of 0-10. Sleep interrupted for 8 nights sometimes for long stretches. Patient don't like taking medication, so only took one tylenol when temp got to 100.8. Never had this kind of reaction to a vaccination. Patient did not receive any treatment. The patient underwent lab tests and procedures which included body temperature:  96.2 100.8 (unit not provided) and pain assessment 2-7 on 30Jan2021. The outcome of events was recovered on 06Feb2021.   Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Back pain, Body temperature, Body temperature increased
Clinical narrative: significant abdominal aches; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; Temperature range 96.2 to 100.8; night sweats; At times had hard time getting around, e.g. standing straight, bending, walking, getting into bed, moving around in bed; Sleep interrupted for 8 nights sometimes for long stretches; Pain moved around intense in one area and then 6, hours later, intense in another area; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL1283) via an unspecified route of administration in right arm on 26Jan2021 at 12:45 (age at vaccination 75-year-old) as dose 1, single for COVID-19 immunization. Patients medical history included osteoarthritis.  Patient was allergic to sulfa drugs. Patients concomitant medications included Calcium, Magnesium, Cranberry and Vitamin D NOS for supplement. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Jan at 15:00, patient experienced significant abdominal aches, pains in hip, pelvic areas as well as mid-spine to limbo-sacral areas. Temperature range 96.2 to 100.8, night sweats. At times had hard time getting around, example like standing straight, bending, walking, getting into bed, moving around in bed. Pain moved around intense in one area and then 6 hours later, intense in another area. Pain range 2 - 7 on scale of 0-10. Sleep interrupted for 8 nights sometimes for long stretches. Patient don't like taking medication, so only took one tylenol when temp got to 100.8. Never had this kind of reaction to a vaccination. Patient did not receive any treatment. The patient underwent lab tests and procedures which included body temperature:  96.2 100.8 (unit not provided) and pain assessment 2-7 on 30Jan2021. The outcome of events was recovered on 06Feb2021.   Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Night sweats, Pain, Pain assessment, Pelvic pain
Clinical narrative: significant abdominal aches; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; Temperature range 96.2 to 100.8; night sweats; At times had hard time getting around, e.g. standing straight, bending, walking, getting into bed, moving around in bed; Sleep interrupted for 8 nights sometimes for long stretches; Pain moved around intense in one area and then 6, hours later, intense in another area; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL1283) via an unspecified route of administration in right arm on 26Jan2021 at 12:45 (age at vaccination 75-year-old) as dose 1, single for COVID-19 immunization. Patients medical history included osteoarthritis.  Patient was allergic to sulfa drugs. Patients concomitant medications included Calcium, Magnesium, Cranberry and Vitamin D NOS for supplement. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Jan at 15:00, patient experienced significant abdominal aches, pains in hip, pelvic areas as well as mid-spine to limbo-sacral areas. Temperature range 96.2 to 100.8, night sweats. At times had hard time getting around, example like standing straight, bending, walking, getting into bed, moving around in bed. Pain moved around intense in one area and then 6 hours later, intense in another area. Pain range 2 - 7 on scale of 0-10. Sleep interrupted for 8 nights sometimes for long stretches. Patient don't like taking medication, so only took one tylenol when temp got to 100.8. Never had this kind of reaction to a vaccination. Patient did not receive any treatment. The patient underwent lab tests and procedures which included body temperature:  96.2 100.8 (unit not provided) and pain assessment 2-7 on 30Jan2021. The outcome of events was recovered on 06Feb2021.   Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Spinal pain
Clinical narrative: significant abdominal aches; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; Temperature range 96.2 to 100.8; night sweats; At times had hard time getting around, e.g. standing straight, bending, walking, getting into bed, moving around in bed; Sleep interrupted for 8 nights sometimes for long stretches; Pain moved around intense in one area and then 6, hours later, intense in another area; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL1283) via an unspecified route of administration in right arm on 26Jan2021 at 12:45 (age at vaccination 75-year-old) as dose 1, single for COVID-19 immunization. Patients medical history included osteoarthritis.  Patient was allergic to sulfa drugs. Patients concomitant medications included Calcium, Magnesium, Cranberry and Vitamin D NOS for supplement. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Jan at 15:00, patient experienced significant abdominal aches, pains in hip, pelvic areas as well as mid-spine to limbo-sacral areas. Temperature range 96.2 to 100.8, night sweats. At times had hard time getting around, example like standing straight, bending, walking, getting into bed, moving around in bed. Pain moved around intense in one area and then 6 hours later, intense in another area. Pain range 2 - 7 on scale of 0-10. Sleep interrupted for 8 nights sometimes for long stretches. Patient don't like taking medication, so only took one tylenol when temp got to 100.8. Never had this kind of reaction to a vaccination. Patient did not receive any treatment. The patient underwent lab tests and procedures which included body temperature:  96.2 100.8 (unit not provided) and pain assessment 2-7 on 30Jan2021. The outcome of events was recovered on 06Feb2021.   Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test, Chest X-ray normal, Computerised tomogram normal, Electrocardiogram normal
Clinical narrative: My blood pressure was 210 over something; blood pressure reading that they recorded was 240 over something; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at 11:30 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported at 3 o'clock the same day. When the patient went for examination it was discovered that patient's blood pressure was 210 over something. The patient had immediately sent me to the emergency clinic for further testing and when the patient got to the emergency clinic the blood pressure reading that they recorded was 240 over something. After 4-5 hours their patient had several tests done. The patient also reported that patient have got a second vaccine scheduled for 05Mar and patient was little concerned about it, even bothering to go because doctor tells patient that the blood pressure reading in 200 range was rather dangerous. The patient underwent lab tests and procedures which included blood pressure measurement was 240 (units not reported), blood pressure measurement: 210 (units not reported). The outcome of the events was reported as unknown.  Information on the lot batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Urine analysis
Clinical narrative: My blood pressure was 210 over something; blood pressure reading that they recorded was 240 over something; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at 11:30 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported at 3 o'clock the same day. When the patient went for examination it was discovered that patient's blood pressure was 210 over something. The patient had immediately sent me to the emergency clinic for further testing and when the patient got to the emergency clinic the blood pressure reading that they recorded was 240 over something. After 4-5 hours their patient had several tests done. The patient also reported that patient have got a second vaccine scheduled for 05Mar and patient was little concerned about it, even bothering to go because doctor tells patient that the blood pressure reading in 200 range was rather dangerous. The patient underwent lab tests and procedures which included blood pressure measurement was 240 (units not reported), blood pressure measurement: 210 (units not reported). The outcome of the events was reported as unknown.  Information on the lot batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal
Clinical narrative: My blood pressure was 210 over something; blood pressure reading that they recorded was 240 over something; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at 11:30 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported at 3 o'clock the same day. When the patient went for examination it was discovered that patient's blood pressure was 210 over something. The patient had immediately sent me to the emergency clinic for further testing and when the patient got to the emergency clinic the blood pressure reading that they recorded was 240 over something. After 4-5 hours their patient had several tests done. The patient also reported that patient have got a second vaccine scheduled for 05Mar and patient was little concerned about it, even bothering to go because doctor tells patient that the blood pressure reading in 200 range was rather dangerous. The patient underwent lab tests and procedures which included blood pressure measurement was 240 (units not reported), blood pressure measurement: 210 (units not reported). The outcome of the events was reported as unknown.  Information on the lot batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Hypoaesthesia, Movement disorder, Sensory disturbance
Clinical narrative: So after 3 hours i was eating pizza and my left side of the mouth felt numbness didn't do anything went to bed and then the next day I had loxodrome couldn't close my left eye. My whole left side was numb and felt weird I went to the doctor and I was diagnosed with Bell's Palsy.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Eye disorder, Hypoaesthesia oral
Clinical narrative: So after 3 hours i was eating pizza and my left side of the mouth felt numbness didn't do anything went to bed and then the next day I had loxodrome couldn't close my left eye. My whole left side was numb and felt weird I went to the doctor and I was diagnosed with Bell's Palsy.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Computerised tomogram head normal, Dyspnoea, Electrocardiogram normal, Lethargy
Clinical narrative: burning sensation in feet and legs; weakness in arms and legs; shortness of breath; feeling like a tight band is around feet; Lethargy; This is a spontaneous report from a contactable consumer (patient). A 88-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported) via an unspecified route of administration, administered in arm right on 31Jan2021 10:00 (at the age of 88years) as single for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included lisinopril , hydrochlorothiazide , diltiazem and omeprazole. No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination, no known allergies. On 04Feb2021 12:00, the patient experienced lethargy, weakness in arms and legs, shortness of breath, burning sensation in feet and legs, feeling like a tight band is around feet. No treatment was received for all events. The outcome for all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dyspnoea, Lethargy, Limb discomfort, Muscular weakness
Clinical narrative: burning sensation in feet and legs; weakness in arms and legs; shortness of breath; feeling like a tight band is around feet; Lethargy; This is a spontaneous report from a contactable consumer (patient). A 88-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported) via an unspecified route of administration, administered in arm right on 31Jan2021 10:00 (at the age of 88years) as single for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included lisinopril , hydrochlorothiazide , diltiazem and omeprazole. No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination, no known allergies. On 04Feb2021 12:00, the patient experienced lethargy, weakness in arms and legs, shortness of breath, burning sensation in feet and legs, feeling like a tight band is around feet. No treatment was received for all events. The outcome for all events was not recovered.  Follow-up attempts are completed. No further information is expected.