chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia
Clinical narrative: My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 17Apr2021 11:15 (Batch/Lot Number: Unknown) as 2nd dose, single for COVID-19 immunisation. The patient's relevant medical history was none. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1 on 27Mar2021 11:15 AM  in the left arm for COVID-19 immunisation. The patient was not pregnant. The patient had no covid-19 prior vaccination. She had not been tested for covid post vaccination. She did not receive any other vaccine within 4 weeks prior to COVID vaccine. On 19Apr2021, the patient experienced her left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Back pain, Blood test, Dysstasia, Ear pain, Headache
Clinical narrative: My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 17Apr2021 11:15 (Batch/Lot Number: Unknown) as 2nd dose, single for COVID-19 immunisation. The patient's relevant medical history was none. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1 on 27Mar2021 11:15 AM  in the left arm for COVID-19 immunisation. The patient was not pregnant. The patient had no covid-19 prior vaccination. She had not been tested for covid post vaccination. She did not receive any other vaccine within 4 weeks prior to COVID vaccine. On 19Apr2021, the patient experienced her left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Impaired work ability, Lip swelling, Magnetic resonance imaging
Clinical narrative: My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 17Apr2021 11:15 (Batch/Lot Number: Unknown) as 2nd dose, single for COVID-19 immunisation. The patient's relevant medical history was none. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1 on 27Mar2021 11:15 AM  in the left arm for COVID-19 immunisation. The patient was not pregnant. The patient had no covid-19 prior vaccination. She had not been tested for covid post vaccination. She did not receive any other vaccine within 4 weeks prior to COVID vaccine. On 19Apr2021, the patient experienced her left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Stiff leg syndrome, Swelling face, Swollen tongue, Tongue movement disturbance
Clinical narrative: My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 17Apr2021 11:15 (Batch/Lot Number: Unknown) as 2nd dose, single for COVID-19 immunisation. The patient's relevant medical history was none. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1 on 27Mar2021 11:15 AM  in the left arm for COVID-19 immunisation. The patient was not pregnant. The patient had no covid-19 prior vaccination. She had not been tested for covid post vaccination. She did not receive any other vaccine within 4 weeks prior to COVID vaccine. On 19Apr2021, the patient experienced her left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Back pain, Ear pain, Feeling abnormal, Hypoacusis, Hypoaesthesia
Clinical narrative: My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; My left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 17Apr2021 11:15 (Batch/Lot Number: Unknown) as 2nd dose, single for COVID-19 immunisation. The patient's relevant medical history was none. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1 on 27Mar2021 11:15 AM  in the left arm for COVID-19 immunisation. The patient was not pregnant. The patient had no covid-19 prior vaccination. She had not been tested for covid post vaccination. She did not receive any other vaccine within 4 weeks prior to COVID vaccine. On 19Apr2021, the patient experienced her left side is numb. Facial numbness, leg numbness, reduced hearing post vaccine, ear pain, back pain, brain fog. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: 3 months after my second dose I got Shingles.; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176, expiration date not reported), via an unspecified route of administration, administered on the left arm on 07Jan2021 14:00 (at the age of 59-years-old), as second dose, single for COVID-19 immunisation. Medical history included drug hypersensitivity (Penicillin allergy) and seasonal allergy. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Three months after patient's second dose, patient had shingles on 10Apr2021 03:00. Patient read recently about patients getting shingles after the Pfizer vaccine. Event resulted to urgent care and physician clinic visit. Patient was treated with pain and anti-viral medications as a result of shingles. Event was assessed as non-serious by the reporter. The outcome of the event was recovering.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pruritus, Rhinorrhoea
Clinical narrative: Runny nose; Chills; Itching; This is a spontaneous report from a contactable consumer (patient) via . A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) on 11Mar2021, 1st dose, single and on 01Apr2021, 2nd dose, single; both given via an unspecified route of administration for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced runny nose, chills and itching on an unspecified date, after each of the doses. The patient asked whether runny nose, chills and itching were related to the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: pt developed generalized papular/drug rush 2 days after vaccine on all extremities and trunk. this eventually  started to resolve after about 3 weeks and a course of prednisone. on 5/6 he developed shortness of breath/chest pressure worse on exertion. he was hospitalized with a negative cardiac workup (telemetry, trops, nuclear stress test) negative chest XR and negative CTA chest for PE. VS remained stable throughout. some improvement now with prednisone. unclear if related to his vaccine but pt feels it was.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Dyspnoea, Lung disorder, Rash, SARS-CoV-2 test
Clinical narrative: pt developed generalized papular/drug rush 2 days after vaccine on all extremities and trunk. this eventually  started to resolve after about 3 weeks and a course of prednisone. on 5/6 he developed shortness of breath/chest pressure worse on exertion. he was hospitalized with a negative cardiac workup (telemetry, trops, nuclear stress test) negative chest XR and negative CTA chest for PE. VS remained stable throughout. some improvement now with prednisone. unclear if related to his vaccine but pt feels it was.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Cardiovascular evaluation, Chest X-ray normal, Chest discomfort, Drug eruption
Clinical narrative: pt developed generalized papular/drug rush 2 days after vaccine on all extremities and trunk. this eventually  started to resolve after about 3 weeks and a course of prednisone. on 5/6 he developed shortness of breath/chest pressure worse on exertion. he was hospitalized with a negative cardiac workup (telemetry, trops, nuclear stress test) negative chest XR and negative CTA chest for PE. VS remained stable throughout. some improvement now with prednisone. unclear if related to his vaccine but pt feels it was.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Rash papular
Clinical narrative: pt developed generalized papular/drug rush 2 days after vaccine on all extremities and trunk. this eventually  started to resolve after about 3 weeks and a course of prednisone. on 5/6 he developed shortness of breath/chest pressure worse on exertion. he was hospitalized with a negative cardiac workup (telemetry, trops, nuclear stress test) negative chest XR and negative CTA chest for PE. VS remained stable throughout. some improvement now with prednisone. unclear if related to his vaccine but pt feels it was.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood pressure systolic decreased, Blood test, Chest pain, Echocardiogram
Clinical narrative: Pericarditis/ Myocarditis.  Chest pain x 1 day, 2 days after 2nd Moderna vaccine injection.  Elevated troponin up to 20.691 on day 2 of admission, Clean coronary cath.  Discharge day 3 with treatment for pericarditis/myocarditis
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pericarditis, Scan with contrast, Ultrasound Doppler
Clinical narrative: Pericarditis/ Myocarditis.  Chest pain x 1 day, 2 days after 2nd Moderna vaccine injection.  Elevated troponin up to 20.691 on day 2 of admission, Clean coronary cath.  Discharge day 3 with treatment for pericarditis/myocarditis
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac normal, Chest pain, Myocarditis, Pericarditis, Troponin increased
Clinical narrative: Pericarditis/ Myocarditis.  Chest pain x 1 day, 2 days after 2nd Moderna vaccine injection.  Elevated troponin up to 20.691 on day 2 of admission, Clean coronary cath.  Discharge day 3 with treatment for pericarditis/myocarditis
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electrocardiogram, Sinus tachycardia, Supraventricular tachycardia
Clinical narrative: had episode of SVT and sinus tachycardia/ heart has been unstable; had episode of SVT and sinus tachycardia/ heart has been unstable; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0153) via an unspecified route of administration, administered on the left arm on 07Apr2021 04:30 1st dose, single for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. On 17Apr2021, she had episode of SVT and sinus tachycardia. Then again on 23Apr2021. Her heart has been unstable since. The events resulted in Emergency room/department or urgent care visit and Doctor or other healthcare professional office/clinic visit. Treatment received: patient is now on meds to regulate her heart and blood tests (15Apr2021: negative). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19: Nasal Swab negative on 15Apr2021. The facility where the vaccine was administered was in a doctor's office/urgent care. Event was reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, SARS-CoV-2 test negative, Sinus tachycardia, Supraventricular tachycardia
Clinical narrative: had episode of SVT and sinus tachycardia/ heart has been unstable; had episode of SVT and sinus tachycardia/ heart has been unstable; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0153) via an unspecified route of administration, administered on the left arm on 07Apr2021 04:30 1st dose, single for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. On 17Apr2021, she had episode of SVT and sinus tachycardia. Then again on 23Apr2021. Her heart has been unstable since. The events resulted in Emergency room/department or urgent care visit and Doctor or other healthcare professional office/clinic visit. Treatment received: patient is now on meds to regulate her heart and blood tests (15Apr2021: negative). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19: Nasal Swab negative on 15Apr2021. The facility where the vaccine was administered was in a doctor's office/urgent care. Event was reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Outcome of the events was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain
Clinical narrative: She did not sleep well due to the discomfort; sore arm; Swollen lymph nodes; Discomfort in neck, shoulder, and elbow on right side; Discomfort in neck, shoulder, and elbow on right side; Discomfort in neck, shoulder, and elbow on right side; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 24Mar2021 morning (Lot Number: ER8730), as single dose, for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HYDROCHLOROTHIAZIDE KRKA) taken for hypertension from around 2 years before. The patient previously took influenza vaccine for immunisation in Oct2020, valsartan for hypertension (discontinued), the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced chest discomfort, neck discomfort and lymphadenopathy. The patient experienced discomfort in neck, shoulder, and elbow on right side (non-serious) in 2021 with outcome of not recovered, sore arm (non-serious) on 24Mar2021 with outcome of not recovered, swollen lymph nodes (non-serious) in 2021 with outcome of not recovered, she did not sleep well due to the discomfort (non-serious) in Apr2021 with outcome of unknown. Therapeutic measures were taken as a result of discomfort in neck, shoulder, and elbow on right side and sore arm and included treatment with ibuprofen about every 3 days for the last week and a half. The patient reported that at first it was just in her arm which was a little bit sore and then it went down to her elbow and has never gone away. Discomfort was actually under her shoulder blade. She clarifies it did not stop at the top of her shoulder, it was also under her shoulder blade.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Lymphadenopathy, Musculoskeletal discomfort, Pain in extremity, Sleep disorder
Clinical narrative: She did not sleep well due to the discomfort; sore arm; Swollen lymph nodes; Discomfort in neck, shoulder, and elbow on right side; Discomfort in neck, shoulder, and elbow on right side; Discomfort in neck, shoulder, and elbow on right side; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 24Mar2021 morning (Lot Number: ER8730), as single dose, for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HYDROCHLOROTHIAZIDE KRKA) taken for hypertension from around 2 years before. The patient previously took influenza vaccine for immunisation in Oct2020, valsartan for hypertension (discontinued), the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced chest discomfort, neck discomfort and lymphadenopathy. The patient experienced discomfort in neck, shoulder, and elbow on right side (non-serious) in 2021 with outcome of not recovered, sore arm (non-serious) on 24Mar2021 with outcome of not recovered, swollen lymph nodes (non-serious) in 2021 with outcome of not recovered, she did not sleep well due to the discomfort (non-serious) in Apr2021 with outcome of unknown. Therapeutic measures were taken as a result of discomfort in neck, shoulder, and elbow on right side and sore arm and included treatment with ibuprofen about every 3 days for the last week and a half. The patient reported that at first it was just in her arm which was a little bit sore and then it went down to her elbow and has never gone away. Discomfort was actually under her shoulder blade. She clarifies it did not stop at the top of her shoulder, it was also under her shoulder blade.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Injection site scab, Neck pain
Clinical narrative: rash which turned into Shingles; small scab at injection site the next day, which turned into large scab; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8730), intramuscularly, administered in arm left on 22Mar2021 at 15:30 (at the age of 64-years-old) at first dose, single for COVID-19 immunization. Medical history included Sjogren's syndrome from 2011 and ongoing which caused dry eyes, asthma, high cholesterol and underactive thyroid. Concomitant medications included theophylline; pravastatin; levothyroxine; and fish oil received within two weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, hasn't been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine and the most recent COVID-19 vaccine was administered at a Pharmacy or Drug Store. The patient stated she got the first dose of the vaccine on 22Mar2021 and was due for her second dose 19Apr2021. However, on 17Apr2021 (reported as the day before reporting) she had a severe headache/excruciating head pain and rash which turned into shingles. She stated that she had an autoimmune disorder, Sjogren's which caused dry eyes and asked if the Pfizer COVID vaccine could activate shingles for someone with this specific autoimmune disorder. As of 04May2021, the patient clarified that she experienced a small scab at injection site the next day, which turned into large scab. About two weeks later, she developed extreme head and neck pain and went to the ER and was diagnosed with shingles on 14Apr2021 at 03:45. The events resulted in emergency room and doctor/other healthcare professional visit. The patient was given pain, nerve, and viral medication as treatment for the event. The outcome of the event was not recovered.  Follow-up (04May2021): New information received from the same contactable consumer (patient) includes: reaction data (the events were diagnosed as shingles, onset date, required doctor/emergency room visit, treatment), concomitant medications, medical history (asthma, high cholesterol and underactive thyroid) and vaccination details were added in the narrative.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol increased, Headache, Herpes zoster, Injection site scab, Neck pain
Clinical narrative: rash which turned into Shingles; small scab at injection site the next day, which turned into large scab; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8730), intramuscularly, administered in arm left on 22Mar2021 at 15:30 (at the age of 64-years-old) at first dose, single for COVID-19 immunization. Medical history included Sjogren's syndrome from 2011 and ongoing which caused dry eyes, asthma, high cholesterol and underactive thyroid. Concomitant medications included theophylline; pravastatin; levothyroxine; and fish oil received within two weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, hasn't been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine and the most recent COVID-19 vaccine was administered at a Pharmacy or Drug Store. The patient stated she got the first dose of the vaccine on 22Mar2021 and was due for her second dose 19Apr2021. However, on 17Apr2021 (reported as the day before reporting) she had a severe headache/excruciating head pain and rash which turned into shingles. She stated that she had an autoimmune disorder, Sjogren's which caused dry eyes and asked if the Pfizer COVID vaccine could activate shingles for someone with this specific autoimmune disorder. As of 04May2021, the patient clarified that she experienced a small scab at injection site the next day, which turned into large scab. About two weeks later, she developed extreme head and neck pain and went to the ER and was diagnosed with shingles on 14Apr2021 at 03:45. The events resulted in emergency room and doctor/other healthcare professional visit. The patient was given pain, nerve, and viral medication as treatment for the event. The outcome of the event was not recovered.  Follow-up (04May2021): New information received from the same contactable consumer (patient) includes: reaction data (the events were diagnosed as shingles, onset date, required doctor/emergency room visit, treatment), concomitant medications, medical history (asthma, high cholesterol and underactive thyroid) and vaccination details were added in the narrative.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: rash which turned into Shingles; small scab at injection site the next day, which turned into large scab; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8730), intramuscularly, administered in arm left on 22Mar2021 at 15:30 (at the age of 64-years-old) at first dose, single for COVID-19 immunization. Medical history included Sjogren's syndrome from 2011 and ongoing which caused dry eyes, asthma, high cholesterol and underactive thyroid. Concomitant medications included theophylline; pravastatin; levothyroxine; and fish oil received within two weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, hasn't been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine and the most recent COVID-19 vaccine was administered at a Pharmacy or Drug Store. The patient stated she got the first dose of the vaccine on 22Mar2021 and was due for her second dose 19Apr2021. However, on 17Apr2021 (reported as the day before reporting) she had a severe headache/excruciating head pain and rash which turned into shingles. She stated that she had an autoimmune disorder, Sjogren's which caused dry eyes and asked if the Pfizer COVID vaccine could activate shingles for someone with this specific autoimmune disorder. As of 04May2021, the patient clarified that she experienced a small scab at injection site the next day, which turned into large scab. About two weeks later, she developed extreme head and neck pain and went to the ER and was diagnosed with shingles on 14Apr2021 at 03:45. The events resulted in emergency room and doctor/other healthcare professional visit. The patient was given pain, nerve, and viral medication as treatment for the event. The outcome of the event was not recovered.  Follow-up (04May2021): New information received from the same contactable consumer (patient) includes: reaction data (the events were diagnosed as shingles, onset date, required doctor/emergency room visit, treatment), concomitant medications, medical history (asthma, high cholesterol and underactive thyroid) and vaccination details were added in the narrative.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiovascular symptom
Clinical narrative: Mild myocarditis; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received bnt162b2, via an unspecified route of administration, administered in left arm on 27Apr2021 12:30 (Lot Number: EW0170) at unknown dosage #, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced mild myocarditis minutes after the second shot (on 27Apr2021 12:45) with outcome of not recovered. 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.  Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Mild myocarditis; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received bnt162b2, via an unspecified route of administration, administered in left arm on 27Apr2021 12:30 (Lot Number: EW0170) at unknown dosage #, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced mild myocarditis minutes after the second shot (on 27Apr2021 12:45) with outcome of not recovered. 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.  Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cognitive disorder, Confusional state, Dizziness, Pain in extremity
Clinical narrative: light dizziness; cognitive reduction ("covid brain fog"); general confusion; sore arm; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left arm on 26Apr2021 at 14:15 (Lot Number: ER8735) as SINGLE DOSE for COVID-19 immunization in pharmacy or drug store. The patient's medical history was not reported. The patient previously took Cefzil and experienced allergies. Concomitant medication included loratadine (LORATADINE 10 mg) at a dose of 10 mg daily from an unspecified date for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left arm on 05Apr2021 at 12:00 (Lot Number: EW0150) as SINGLE DOSE for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021 at 20:15, the patient experienced sore arm. On 27Apr2021 at 09:00, the patient was having general confusion/cognitive reduction ("COVID brain fog"), and on the same day at 11:00, the patient felt light dizziness. No corrective measure was received by the patient for the reported events. The outcome was reported as recovered in morning of 28Apr2021 for the reported events.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Flushing, Nausea
Clinical narrative: Skin turned red and blotchy; Heart racing; Light headed; Lasted 5 mins bad. 15 mins to feel back to normal.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Palpitations, Rash macular
Clinical narrative: Skin turned red and blotchy; Heart racing; Light headed; Lasted 5 mins bad. 15 mins to feel back to normal.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Muscle twitching
Clinical narrative: Client reports she began to experience muscle twitching to vaccinated arm about 20 minutes after vaccination. Client reports she told the EMT during her observation. Client was guided to private observation room and evaluated by EMTs. Client reports upon assessment EMTs found that she had a blood pressure of 190s systolically. Client cannot recall exact blood pressure. Client denied any other symptoms at this time other than muscle twitching. Client was taken to the Emergency Room where she was evaluated. Client reports her blood pressure went down on its own without the need of medications.  Client denies history of hypertension.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Muscle twitching
Clinical narrative: Client reports she began to experience muscle twitching to vaccinated arm about 20 minutes after vaccination. Client reports she told the EMT during her observation. Client was guided to private observation room and evaluated by EMTs. Client reports upon assessment EMTs found that she had a blood pressure of 190s systolically. Client cannot recall exact blood pressure. Client denied any other symptoms at this time other than muscle twitching. Client was taken to the Emergency Room where she was evaluated. Client reports her blood pressure went down on its own without the need of medications.  Client denies history of hypertension.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Patient developed nausea and vomiting on 5/8, 7 days after immunization.  The symptoms persisted for 5 days, when he presented to the ED (5/12/21) and was diagnosed with new onset diabetes in diabetic ketoacidosis
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diabetes mellitus, Diabetic ketoacidosis, Nausea, Vomiting
Clinical narrative: Patient developed nausea and vomiting on 5/8, 7 days after immunization.  The symptoms persisted for 5 days, when he presented to the ED (5/12/21) and was diagnosed with new onset diabetes in diabetic ketoacidosis
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anosmia, Blood thyroid stimulating hormone normal, C-reactive protein normal, Chronic sinusitis, Full blood count normal
Clinical narrative: I acquired Covid on January 13. I was sick for three days, largely with headaches. I lost my sense of smell. After approximately 7 weeks, I had recovered most of my sense of smell. I received dose 1 of Moderna on March 2. Four days later I noticed that my sense of smell had diminished substantially. I contacted my primary and was assured that it wasn't a result of the vaccine. I saw an EENT, and he too assured me it wasn't because of the vaccine. I was put on Flonase and one course of steroids (12 days). After 2 weeks, my sense of smell was returning. I received my second dose on 3/30. Within 12 hours I knew something was wrong. My sense of smell seemed to be obliterated. It felt like there was a "hole" in the center of my nose. Within 36 hours, the turbinates in my nose were hypertrophic. I have never suffered seasonal allergies and had never even heard the word "turbinate" before this. 45 days later, my left nostril is blocked. My right nostril is nearly blocked. I have fluid behind both ears, and my hearing has diminshed.  I feel completely let down by the medical establishment and even the CDC. There is no way that I should have been advised to have the vaccine just 40 days after contracting covid. All of the promises that the vaccine can't reduce sense of smell because there's no Covid in the vaccine are misleading. My immune system responded to the vaccine by attacking the site of the original infection, which was my nose. This has been devastating to me. I am depressed, anxious, and hopeless that this will correct itself. I will likely suffer some percentage of hearing loss. I was completely recovered from Covid, and it's only these vaccines that have ruined my health.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Glycosylated haemoglobin normal, HIV test negative, Lipids normal, Metabolic function test normal, Nasal oedema
Clinical narrative: I acquired Covid on January 13. I was sick for three days, largely with headaches. I lost my sense of smell. After approximately 7 weeks, I had recovered most of my sense of smell. I received dose 1 of Moderna on March 2. Four days later I noticed that my sense of smell had diminished substantially. I contacted my primary and was assured that it wasn't a result of the vaccine. I saw an EENT, and he too assured me it wasn't because of the vaccine. I was put on Flonase and one course of steroids (12 days). After 2 weeks, my sense of smell was returning. I received my second dose on 3/30. Within 12 hours I knew something was wrong. My sense of smell seemed to be obliterated. It felt like there was a "hole" in the center of my nose. Within 36 hours, the turbinates in my nose were hypertrophic. I have never suffered seasonal allergies and had never even heard the word "turbinate" before this. 45 days later, my left nostril is blocked. My right nostril is nearly blocked. I have fluid behind both ears, and my hearing has diminshed.  I feel completely let down by the medical establishment and even the CDC. There is no way that I should have been advised to have the vaccine just 40 days after contracting covid. All of the promises that the vaccine can't reduce sense of smell because there's no Covid in the vaccine are misleading. My immune system responded to the vaccine by attacking the site of the original infection, which was my nose. This has been devastating to me. I am depressed, anxious, and hopeless that this will correct itself. I will likely suffer some percentage of hearing loss. I was completely recovered from Covid, and it's only these vaccines that have ruined my health.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal, SARS-CoV-2 test negative, Treponema test negative
Clinical narrative: I acquired Covid on January 13. I was sick for three days, largely with headaches. I lost my sense of smell. After approximately 7 weeks, I had recovered most of my sense of smell. I received dose 1 of Moderna on March 2. Four days later I noticed that my sense of smell had diminished substantially. I contacted my primary and was assured that it wasn't a result of the vaccine. I saw an EENT, and he too assured me it wasn't because of the vaccine. I was put on Flonase and one course of steroids (12 days). After 2 weeks, my sense of smell was returning. I received my second dose on 3/30. Within 12 hours I knew something was wrong. My sense of smell seemed to be obliterated. It felt like there was a "hole" in the center of my nose. Within 36 hours, the turbinates in my nose were hypertrophic. I have never suffered seasonal allergies and had never even heard the word "turbinate" before this. 45 days later, my left nostril is blocked. My right nostril is nearly blocked. I have fluid behind both ears, and my hearing has diminshed.  I feel completely let down by the medical establishment and even the CDC. There is no way that I should have been advised to have the vaccine just 40 days after contracting covid. All of the promises that the vaccine can't reduce sense of smell because there's no Covid in the vaccine are misleading. My immune system responded to the vaccine by attacking the site of the original infection, which was my nose. This has been devastating to me. I am depressed, anxious, and hopeless that this will correct itself. I will likely suffer some percentage of hearing loss. I was completely recovered from Covid, and it's only these vaccines that have ruined my health.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anosmia, Anxiety, Audiogram abnormal, Depression, Hypoacusis
Clinical narrative: I acquired Covid on January 13. I was sick for three days, largely with headaches. I lost my sense of smell. After approximately 7 weeks, I had recovered most of my sense of smell. I received dose 1 of Moderna on March 2. Four days later I noticed that my sense of smell had diminished substantially. I contacted my primary and was assured that it wasn't a result of the vaccine. I saw an EENT, and he too assured me it wasn't because of the vaccine. I was put on Flonase and one course of steroids (12 days). After 2 weeks, my sense of smell was returning. I received my second dose on 3/30. Within 12 hours I knew something was wrong. My sense of smell seemed to be obliterated. It felt like there was a "hole" in the center of my nose. Within 36 hours, the turbinates in my nose were hypertrophic. I have never suffered seasonal allergies and had never even heard the word "turbinate" before this. 45 days later, my left nostril is blocked. My right nostril is nearly blocked. I have fluid behind both ears, and my hearing has diminshed.  I feel completely let down by the medical establishment and even the CDC. There is no way that I should have been advised to have the vaccine just 40 days after contracting covid. All of the promises that the vaccine can't reduce sense of smell because there's no Covid in the vaccine are misleading. My immune system responded to the vaccine by attacking the site of the original infection, which was my nose. This has been devastating to me. I am depressed, anxious, and hopeless that this will correct itself. I will likely suffer some percentage of hearing loss. I was completely recovered from Covid, and it's only these vaccines that have ruined my health.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nasal congestion, Nasal turbinate hypertrophy
Clinical narrative: I acquired Covid on January 13. I was sick for three days, largely with headaches. I lost my sense of smell. After approximately 7 weeks, I had recovered most of my sense of smell. I received dose 1 of Moderna on March 2. Four days later I noticed that my sense of smell had diminished substantially. I contacted my primary and was assured that it wasn't a result of the vaccine. I saw an EENT, and he too assured me it wasn't because of the vaccine. I was put on Flonase and one course of steroids (12 days). After 2 weeks, my sense of smell was returning. I received my second dose on 3/30. Within 12 hours I knew something was wrong. My sense of smell seemed to be obliterated. It felt like there was a "hole" in the center of my nose. Within 36 hours, the turbinates in my nose were hypertrophic. I have never suffered seasonal allergies and had never even heard the word "turbinate" before this. 45 days later, my left nostril is blocked. My right nostril is nearly blocked. I have fluid behind both ears, and my hearing has diminshed.  I feel completely let down by the medical establishment and even the CDC. There is no way that I should have been advised to have the vaccine just 40 days after contracting covid. All of the promises that the vaccine can't reduce sense of smell because there's no Covid in the vaccine are misleading. My immune system responded to the vaccine by attacking the site of the original infection, which was my nose. This has been devastating to me. I am depressed, anxious, and hopeless that this will correct itself. I will likely suffer some percentage of hearing loss. I was completely recovered from Covid, and it's only these vaccines that have ruined my health.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Cardiac failure, Chills, Ejection fraction decreased
Clinical narrative: Hospitalization kidney failure heart failure respiratory failure had to be ventilated. Six days in Medical Center and 10 days in Medical Center
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Hypophagia, Leukocytosis, Mechanical ventilation, Myalgia
Clinical narrative: Hospitalization kidney failure heart failure respiratory failure had to be ventilated. Six days in Medical Center and 10 days in Medical Center
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: Hospitalization kidney failure heart failure respiratory failure had to be ventilated. Six days in Medical Center and 10 days in Medical Center
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Chest X-ray, Computerised tomogram, Electrocardiogram, Mechanical ventilation
Clinical narrative: Hospitalization kidney failure heart failure respiratory failure had to be ventilated. Six days in Medical Center and 10 days in Medical Center
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Renal failure, Respiratory failure, Ultrasound scan
Clinical narrative: Hospitalization kidney failure heart failure respiratory failure had to be ventilated. Six days in Medical Center and 10 days in Medical Center