chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: (swelling of cheeks, eyes, throat and neck) Narrative:  A 68 yo male was reported with a historical ADR of Angioedema after receiving Covid vaccine The reporting attending physician note included patient developed swelling of cheeks, eyes, throat and neck within four hours of receiving the vaccine and was advised not to take the second shot. Other documentation from patient's Tel call included refusal to go to the ER and patient's description of reaction as experiencing chills when he got home, went to sleep and when he woke up found his face slightly swollen, involving his eyes, cheeks and glands under his neck with no lip, tongue or throat swelling. PMH - Heart Murmur, OA, Cocaine abuse, Sleep Walking, Migraine, Depression, Crohn's Disease, Rectal Bleeding, HTN, Chronic Hepatitis, Anxiety, OSA
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site pain Narrative:  Other Relevant History:
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Chest X-ray normal, Discomfort, Feeling abnormal, Full blood count normal
Clinical narrative: Dizziness & palpitations immediately post vaccine administration; resolved without medical intervention. Near syncope.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test normal, Palpitations, Tachycardia, Troponin normal
Clinical narrative: Dizziness & palpitations immediately post vaccine administration; resolved without medical intervention. Near syncope.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Palpitations, Presyncope
Clinical narrative: Dizziness & palpitations immediately post vaccine administration; resolved without medical intervention. Near syncope.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal stiffness, SARS-CoV-2 test, Skin discolouration
Clinical narrative: 1/9/21 - Discoloration (purple in color) in toes bilaterally, worse on outside toes.  Inititally purple color was worse on 3 toes on right foot and one toe on left foot.  Resolved in 2-3 days. When warm discoloration noted, when cold discoloration appears to resolve.  No pain or numbness 2/27/21 - Discoloration (deeper purple in color) in toes bilaterally, again worse on outside pinky toes.  Worse on right foot then left. Resolved in 2-3 Days.  Discoloration unchanged with temp changes. No pain or numbness. 3/18/21 - Discoloration (dark purple, non blanching on right and left outer toes).  Also extending to inside of right foot by big toe and along the side of the foot at pinky toe.  Starting to affect foot as well as toes.  Non painful.  Toes are purple in color despite being warm or cold.  Warming toes does not change appearance.  At 4 days outer pinky toes are light red in color and feet appear dusky.  No pain or numbness.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody, Inflammatory marker test, Laboratory test, SARS-CoV-2 test negative, Skin discolouration
Clinical narrative: 1/9/21 - Discoloration (purple in color) in toes bilaterally, worse on outside toes.  Inititally purple color was worse on 3 toes on right foot and one toe on left foot.  Resolved in 2-3 days. When warm discoloration noted, when cold discoloration appears to resolve.  No pain or numbness 2/27/21 - Discoloration (deeper purple in color) in toes bilaterally, again worse on outside pinky toes.  Worse on right foot then left. Resolved in 2-3 Days.  Discoloration unchanged with temp changes. No pain or numbness. 3/18/21 - Discoloration (dark purple, non blanching on right and left outer toes).  Also extending to inside of right foot by big toe and along the side of the foot at pinky toe.  Starting to affect foot as well as toes.  Non painful.  Toes are purple in color despite being warm or cold.  Warming toes does not change appearance.  At 4 days outer pinky toes are light red in color and feet appear dusky.  No pain or numbness.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: 1/9/21 - Discoloration (purple in color) in toes bilaterally, worse on outside toes.  Inititally purple color was worse on 3 toes on right foot and one toe on left foot.  Resolved in 2-3 days. When warm discoloration noted, when cold discoloration appears to resolve.  No pain or numbness 2/27/21 - Discoloration (deeper purple in color) in toes bilaterally, again worse on outside pinky toes.  Worse on right foot then left. Resolved in 2-3 Days.  Discoloration unchanged with temp changes. No pain or numbness. 3/18/21 - Discoloration (dark purple, non blanching on right and left outer toes).  Also extending to inside of right foot by big toe and along the side of the foot at pinky toe.  Starting to affect foot as well as toes.  Non painful.  Toes are purple in color despite being warm or cold.  Warming toes does not change appearance.  At 4 days outer pinky toes are light red in color and feet appear dusky.  No pain or numbness.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: PLEASE HELP.  I have had moderate to severe pain at upper left arm injection site starting approximately 1/15/2021, a day after the injection, until the present.  It manifests itself mostly during sleep and awakes me with significant constant pain while in a reclining position.  When I sit up, it is somewhat alleviated and I have to take extended release tylenol (650mg) to get back to sleep.  I wake up most mornings with the same left arm pain at the injections site.  On March 16, 2021, my internist examined it and found the same bump in my upper left arm and said it is definitely from the 1st vaccination.  He suggested heat on and off for 20 minutes.  I tried it two evenings in a row and the pain got worse in bed.  Since I cannot take any NSAIDs due to my aspirin regimen for Coronary Artery Disease, there seems nothing else to do, but I am worried that some long lasting detriment is happening to my body.  PLEASE HELP.  I did not have any such symptoms from the second Moderna vaccine received 2/11/2021.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Peripheral swelling, Sleep disorder
Clinical narrative: PLEASE HELP.  I have had moderate to severe pain at upper left arm injection site starting approximately 1/15/2021, a day after the injection, until the present.  It manifests itself mostly during sleep and awakes me with significant constant pain while in a reclining position.  When I sit up, it is somewhat alleviated and I have to take extended release tylenol (650mg) to get back to sleep.  I wake up most mornings with the same left arm pain at the injections site.  On March 16, 2021, my internist examined it and found the same bump in my upper left arm and said it is definitely from the 1st vaccination.  He suggested heat on and off for 20 minutes.  I tried it two evenings in a row and the pain got worse in bed.  Since I cannot take any NSAIDs due to my aspirin regimen for Coronary Artery Disease, there seems nothing else to do, but I am worried that some long lasting detriment is happening to my body.  PLEASE HELP.  I did not have any such symptoms from the second Moderna vaccine received 2/11/2021.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Chest X-ray, Condition aggravated, Electrocardiogram, Laboratory test
Clinical narrative: Patient reported that she had a episode of Afib that required hospitalization X24 hours. Pt states she has a hx of afib but has not had an episode in several years and has always been easily converted. This episode did not convert easily and required the patient to stay overnight at the hospital. Additional questions regarding treatment should be directed to the hospital or to the patient.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Patient reported that she had a episode of Afib that required hospitalization X24 hours. Pt states she has a hx of afib but has not had an episode in several years and has always been easily converted. This episode did not convert easily and required the patient to stay overnight at the hospital. Additional questions regarding treatment should be directed to the hospital or to the patient.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Patient reported that she had a episode of Afib that required hospitalization X24 hours. Pt states she has a hx of afib but has not had an episode in several years and has always been easily converted. This episode did not convert easily and required the patient to stay overnight at the hospital. Additional questions regarding treatment should be directed to the hospital or to the patient.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pruritus, Neck pain, Pain in extremity, Urticaria
Clinical narrative: 2/2/2021- Severe headache, left sided neck pain, left arm pain, left arm swelling, redness 2/12/2021- Rash (hives) left side of body, especially face, neck, chest 2/15/2021- Awoke to low vibration/humming in left ear, progressively worse (louder) 2/19/2021 - Saw PCP who diagnosed tinnitus,  referred to ENT 3/16/2021- Saw ENT . Hearing within normal limits. Vibration/humming tinnitus worse. MRI to be scheduled to rule out another cause. ENT stated that he had seen another patient with onset of tinnitus post COVID vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Erythema, Headache, Neck pain, Pain in extremity
Clinical narrative: 2/2/2021- Severe headache, left sided neck pain, left arm pain, left arm swelling, redness 2/12/2021- Rash (hives) left side of body, especially face, neck, chest 2/15/2021- Awoke to low vibration/humming in left ear, progressively worse (louder) 2/19/2021 - Saw PCP who diagnosed tinnitus,  referred to ENT 3/16/2021- Saw ENT . Hearing within normal limits. Vibration/humming tinnitus worse. MRI to be scheduled to rule out another cause. ENT stated that he had seen another patient with onset of tinnitus post COVID vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Rash, Tinnitus, Urticaria
Clinical narrative: 2/2/2021- Severe headache, left sided neck pain, left arm pain, left arm swelling, redness 2/12/2021- Rash (hives) left side of body, especially face, neck, chest 2/15/2021- Awoke to low vibration/humming in left ear, progressively worse (louder) 2/19/2021 - Saw PCP who diagnosed tinnitus,  referred to ENT 3/16/2021- Saw ENT . Hearing within normal limits. Vibration/humming tinnitus worse. MRI to be scheduled to rule out another cause. ENT stated that he had seen another patient with onset of tinnitus post COVID vaccine.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received Moderna COVID vaccine in error  (recommendations are 18 or older)  - should have received Pfizer vaccine (which is for 16 years and older) .
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Left index finger suddenly developed considerable pain in the tip of the finger and a slight numbness there as well; Left index finger suddenly developed considerable pain in the tip of the finger and a slight numbness there as well; This is a spontaneous report from a contactable consumer (the patient). A 77-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 05Feb2021 at 13:00 (at the age of 76-year-old) as a single dose for COVID-19 immunization. Medical history included heart condition. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Feb2021, the patient experienced left index finger suddenly developed considerable pain in the tip of the finger and a slight numbness there as well. The patient did not receive any treatment for the events. The clinical outcome of the "left index finger suddenly developed considerable pain in the tip of the finger and a slight numbness there as well" was not resolved.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hypertension
Clinical narrative: within 1 1/2 hrs of the shot fast heart rate of 135; blood pressure 205/101 went to ER; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of  BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot Number: EN6203, expiry date not reported) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension, COPD (chronic obstructive pulmonary disease), AFIB (atrial fibrillation), cardiac arrest, asthma, PMR (polymyalgia rheumatica), LBBB (bundle branch block left) from an unknown date and unknown if ongoing and ICD Implant (implantable defibrillator insertion) all from unknown dates. The patient previously took ciprofloxacin [ciprofloxacin lactate], norvasc, lidocaine and experienced allergies (Known allergies). The patient experienced within 1 1/2 hrs of the shot fast heart rate of 135 and blood pressure 205/101 went to ER on 24Feb2021 at 16:45. The events were reported to have caused hospitalization. The patient underwent lab tests and procedures which included blood pressure measurement: 205/101 and heart rate: 135   both on unspecified date. Therapeutic measures were taken as a result of within 1 1/2 hrs of the shot fast heart rate of 135 and blood pressure 205/101 went to ER which was reported as Ae treatment: EKG and Heart Monitoring. Outcome of the events was Recovered/Resolved with Sequel.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased
Clinical narrative: within 1 1/2 hrs of the shot fast heart rate of 135; blood pressure 205/101 went to ER; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of  BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot Number: EN6203, expiry date not reported) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension, COPD (chronic obstructive pulmonary disease), AFIB (atrial fibrillation), cardiac arrest, asthma, PMR (polymyalgia rheumatica), LBBB (bundle branch block left) from an unknown date and unknown if ongoing and ICD Implant (implantable defibrillator insertion) all from unknown dates. The patient previously took ciprofloxacin [ciprofloxacin lactate], norvasc, lidocaine and experienced allergies (Known allergies). The patient experienced within 1 1/2 hrs of the shot fast heart rate of 135 and blood pressure 205/101 went to ER on 24Feb2021 at 16:45. The events were reported to have caused hospitalization. The patient underwent lab tests and procedures which included blood pressure measurement: 205/101 and heart rate: 135   both on unspecified date. Therapeutic measures were taken as a result of within 1 1/2 hrs of the shot fast heart rate of 135 and blood pressure 205/101 went to ER which was reported as Ae treatment: EKG and Heart Monitoring. Outcome of the events was Recovered/Resolved with Sequel.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal distension, Computerised tomogram normal, Constipation, Discomfort, Laboratory test normal
Clinical narrative: Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; This is a spontaneous report from a contactable consumer.   A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in the right arm on 15Feb2021 as single dose for covid-19 immunization at age 73 years.  Medical history included stroke and heart disease from an unknown date.  There were unspecified concomitant medications taken within two weeks.    The patient previously took BNT162B2 (Lot number EL9261) on 27Jan2021 as the first dose for covid-19 immunization at 73 years old, xylometazoline hydrochloride (SUDAFED) and experienced allergy.  The patient experienced extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI on 20Feb2021, at  12:00; the event was serious as it involved hospitalization for three days.  The patient underwent lab tests and procedures on an unspecified date  which included computerised tomogram (CT) scan with contrast and endoscopy, both with unknown results. Details were as follows: The patient had extreme bloating in stomach, upper chest, neck and face. The events was described as enough discomfort to undergo upper GI, CT Scan with Contrast. The patient  was hospitalized for three days, and  had an outpatient endoscopy. No Covid  was noted prior  to vaccination, and the patient has not been tested post vaccination. It was unknown if treatments were given for the event. The outcome of extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI was not recovered.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling, Swelling face, X-ray with contrast upper gastrointestinal tract normal
Clinical narrative: Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; This is a spontaneous report from a contactable consumer.   A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in the right arm on 15Feb2021 as single dose for covid-19 immunization at age 73 years.  Medical history included stroke and heart disease from an unknown date.  There were unspecified concomitant medications taken within two weeks.    The patient previously took BNT162B2 (Lot number EL9261) on 27Jan2021 as the first dose for covid-19 immunization at 73 years old, xylometazoline hydrochloride (SUDAFED) and experienced allergy.  The patient experienced extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI on 20Feb2021, at  12:00; the event was serious as it involved hospitalization for three days.  The patient underwent lab tests and procedures on an unspecified date  which included computerised tomogram (CT) scan with contrast and endoscopy, both with unknown results. Details were as follows: The patient had extreme bloating in stomach, upper chest, neck and face. The events was described as enough discomfort to undergo upper GI, CT Scan with Contrast. The patient  was hospitalized for three days, and  had an outpatient endoscopy. No Covid  was noted prior  to vaccination, and the patient has not been tested post vaccination. It was unknown if treatments were given for the event. The outcome of extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI was not recovered.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Computerised tomogram, Endoscopy
Clinical narrative: Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; This is a spontaneous report from a contactable consumer.   A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in the right arm on 15Feb2021 as single dose for covid-19 immunization at age 73 years.  Medical history included stroke and heart disease from an unknown date.  There were unspecified concomitant medications taken within two weeks.    The patient previously took BNT162B2 (Lot number EL9261) on 27Jan2021 as the first dose for covid-19 immunization at 73 years old, xylometazoline hydrochloride (SUDAFED) and experienced allergy.  The patient experienced extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI on 20Feb2021, at  12:00; the event was serious as it involved hospitalization for three days.  The patient underwent lab tests and procedures on an unspecified date  which included computerised tomogram (CT) scan with contrast and endoscopy, both with unknown results. Details were as follows: The patient had extreme bloating in stomach, upper chest, neck and face. The events was described as enough discomfort to undergo upper GI, CT Scan with Contrast. The patient  was hospitalized for three days, and  had an outpatient endoscopy. No Covid  was noted prior  to vaccination, and the patient has not been tested post vaccination. It was unknown if treatments were given for the event. The outcome of extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI was not recovered.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Chest pain, Computerised tomogram pelvis, Computerised tomogram thorax normal, Echocardiogram
Clinical narrative: Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; This is a spontaneous report from a contactable consumer.   A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in the right arm on 15Feb2021 as single dose for covid-19 immunization at age 73 years.  Medical history included stroke and heart disease from an unknown date.  There were unspecified concomitant medications taken within two weeks.    The patient previously took BNT162B2 (Lot number EL9261) on 27Jan2021 as the first dose for covid-19 immunization at 73 years old, xylometazoline hydrochloride (SUDAFED) and experienced allergy.  The patient experienced extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI on 20Feb2021, at  12:00; the event was serious as it involved hospitalization for three days.  The patient underwent lab tests and procedures on an unspecified date  which included computerised tomogram (CT) scan with contrast and endoscopy, both with unknown results. Details were as follows: The patient had extreme bloating in stomach, upper chest, neck and face. The events was described as enough discomfort to undergo upper GI, CT Scan with Contrast. The patient  was hospitalized for three days, and  had an outpatient endoscopy. No Covid  was noted prior  to vaccination, and the patient has not been tested post vaccination. It was unknown if treatments were given for the event. The outcome of extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI was not recovered.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endoscopy normal, Endoscopy upper gastrointestinal tract normal, Scan with contrast normal, Ultrasound abdomen normal, Ultrasound chest
Clinical narrative: Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; This is a spontaneous report from a contactable consumer.   A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in the right arm on 15Feb2021 as single dose for covid-19 immunization at age 73 years.  Medical history included stroke and heart disease from an unknown date.  There were unspecified concomitant medications taken within two weeks.    The patient previously took BNT162B2 (Lot number EL9261) on 27Jan2021 as the first dose for covid-19 immunization at 73 years old, xylometazoline hydrochloride (SUDAFED) and experienced allergy.  The patient experienced extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI on 20Feb2021, at  12:00; the event was serious as it involved hospitalization for three days.  The patient underwent lab tests and procedures on an unspecified date  which included computerised tomogram (CT) scan with contrast and endoscopy, both with unknown results. Details were as follows: The patient had extreme bloating in stomach, upper chest, neck and face. The events was described as enough discomfort to undergo upper GI, CT Scan with Contrast. The patient  was hospitalized for three days, and  had an outpatient endoscopy. No Covid  was noted prior  to vaccination, and the patient has not been tested post vaccination. It was unknown if treatments were given for the event. The outcome of extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI was not recovered.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound scan normal
Clinical narrative: Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; This is a spontaneous report from a contactable consumer.   A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in the right arm on 15Feb2021 as single dose for covid-19 immunization at age 73 years.  Medical history included stroke and heart disease from an unknown date.  There were unspecified concomitant medications taken within two weeks.    The patient previously took BNT162B2 (Lot number EL9261) on 27Jan2021 as the first dose for covid-19 immunization at 73 years old, xylometazoline hydrochloride (SUDAFED) and experienced allergy.  The patient experienced extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI on 20Feb2021, at  12:00; the event was serious as it involved hospitalization for three days.  The patient underwent lab tests and procedures on an unspecified date  which included computerised tomogram (CT) scan with contrast and endoscopy, both with unknown results. Details were as follows: The patient had extreme bloating in stomach, upper chest, neck and face. The events was described as enough discomfort to undergo upper GI, CT Scan with Contrast. The patient  was hospitalized for three days, and  had an outpatient endoscopy. No Covid  was noted prior  to vaccination, and the patient has not been tested post vaccination. It was unknown if treatments were given for the event. The outcome of extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI was not recovered.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Paraesthesia oral
Clinical narrative: Hot, itchy rash all over body (abdomen, arms, legs, head, inguinal region). Prescribed prednisone and triamcinolone cream.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Pruritus, Rash
Clinical narrative: Hot, itchy rash all over body (abdomen, arms, legs, head, inguinal region). Prescribed prednisone and triamcinolone cream.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Pain
Clinical narrative: The patient got the shot in his right arm and 18 to 24 hours later his left arm and leg began to feel tingling and numb.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: The patient got the shot in his right arm and 18 to 24 hours later his left arm and leg began to feel tingling and numb.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Patient C/O dizziness approximately 10 minutes in the observation BP at 10:45 122/88,  80 HR, 95.7 temp. 11:05 am BP  120/82, 78 HR, 95.7 temp.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Flushing, Heart rate increased, Hyperhidrosis, Myocardial infarction
Clinical narrative: Patient C/O dizziness approximately 10 minutes in the observation BP at 10:45 122/88,  80 HR, 95.7 temp. 11:05 am BP  120/82, 78 HR, 95.7 temp.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Palpitations, Pyrexia, Thyroid function test abnormal
Clinical narrative: Patient C/O dizziness approximately 10 minutes in the observation BP at 10:45 122/88,  80 HR, 95.7 temp. 11:05 am BP  120/82, 78 HR, 95.7 temp.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature decreased, Dizziness
Clinical narrative: Patient C/O dizziness approximately 10 minutes in the observation BP at 10:45 122/88,  80 HR, 95.7 temp. 11:05 am BP  120/82, 78 HR, 95.7 temp.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pharyngeal swelling, Swelling, Swollen tongue
Clinical narrative: throat swelling; tongue swelling; facial numbness; pruritus on the left side of face extending to the throat, itchy; A spontaneous report was received from a consumer concerning a 37-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of throat swelling, tongue swelling, itchy, facial numbness, pruritus on the left side of face extending to the throat, itchiness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 012MZ0A (012M20A)) intramuscularly for prophylaxis of COVID-19 infection.   On 3 Mar 2021, prior to the onset of the events the patient received the second of two planned doses of mRNA-1273 (lot/batch: 029A21A (024A21A)) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced an acute sensitivity reaction 20 minutes after inoculation of second dose of Moderna COVID19 vaccine, which included the events of throat swelling, tongue swelling, itchy, facial numbness, pruritus on the left side of face extending to the throat, itchiness. She was taken to the ER and given a steroid injection, antihistamine and Pepcid. When she was discharged, the treatment given was prednisone, Pepcid and Benadryl as needed she continued this until Sunday. On Monday, she was still symptomatic (swelling of throat and tongue, itchiness and facial numbness) doctor gave her another 5 days of 60mg of prednisone and Benadryl as needed. The symptoms still persist  Treatment details included steroid injection, antihistamine and Pepcid, Prednisone, Pepcid and Benadryl as needed, 5 days of 60mg of prednisone and Benadryl as needed.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events throat swelling, tongue swelling, itchy, facial numbness, pruritus on the left side of face extending to the throat, itchiness was not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pharyngeal swelling, Pruritus, Swollen tongue
Clinical narrative: throat swelling; tongue swelling; facial numbness; pruritus on the left side of face extending to the throat, itchy; A spontaneous report was received from a consumer concerning a 37-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of throat swelling, tongue swelling, itchy, facial numbness, pruritus on the left side of face extending to the throat, itchiness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 012MZ0A (012M20A)) intramuscularly for prophylaxis of COVID-19 infection.   On 3 Mar 2021, prior to the onset of the events the patient received the second of two planned doses of mRNA-1273 (lot/batch: 029A21A (024A21A)) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced an acute sensitivity reaction 20 minutes after inoculation of second dose of Moderna COVID19 vaccine, which included the events of throat swelling, tongue swelling, itchy, facial numbness, pruritus on the left side of face extending to the throat, itchiness. She was taken to the ER and given a steroid injection, antihistamine and Pepcid. When she was discharged, the treatment given was prednisone, Pepcid and Benadryl as needed she continued this until Sunday. On Monday, she was still symptomatic (swelling of throat and tongue, itchiness and facial numbness) doctor gave her another 5 days of 60mg of prednisone and Benadryl as needed. The symptoms still persist  Treatment details included steroid injection, antihistamine and Pepcid, Prednisone, Pepcid and Benadryl as needed, 5 days of 60mg of prednisone and Benadryl as needed.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events throat swelling, tongue swelling, itchy, facial numbness, pruritus on the left side of face extending to the throat, itchiness was not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Audiogram abnormal, Computerised tomogram, Deafness unilateral, Ear discomfort, Laboratory test
Clinical narrative: Patient without prior otologic history noted to have onset of sudden hearing loss on the right ear. He also noted dizziness. This was noted approximately 6 days after 1st dose of vaccine. Currently treated with oral and intertympanic steroid injections.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Nasal discomfort, Vertigo
Clinical narrative: Patient without prior otologic history noted to have onset of sudden hearing loss on the right ear. He also noted dizziness. This was noted approximately 6 days after 1st dose of vaccine. Currently treated with oral and intertympanic steroid injections.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Sudden hearing loss
Clinical narrative: Patient without prior otologic history noted to have onset of sudden hearing loss on the right ear. He also noted dizziness. This was noted approximately 6 days after 1st dose of vaccine. Currently treated with oral and intertympanic steroid injections.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Chills, Dyspnoea, Pyrexia, Sepsis
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Flushing
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hyperventilation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Soon after vaccination was received my tongue started tingling and then went from tingling to feeling really heavy, and then I went to a place where I started feeling shortness of breath and very weak. I could not breath very well, the nurse on site gave me an Epi-Pen and it helped. I was transferred to ER at Hospital, where they monitored me and they told me my pressure was elevated. I don't have any HBP issues. They kept monitoring my heart and pressure. After 3 + hours things had went back to normal. On Friday, the day of the vaccine, I felt very heavy, tired and just out of it. I could just sleep after I got home. I finally started feeling like myself on the 03/16/2021,
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure increased, Discomfort, Dyspnoea, Fatigue
Clinical narrative: Soon after vaccination was received my tongue started tingling and then went from tingling to feeling really heavy, and then I went to a place where I started feeling shortness of breath and very weak. I could not breath very well, the nurse on site gave me an Epi-Pen and it helped. I was transferred to ER at Hospital, where they monitored me and they told me my pressure was elevated. I don't have any HBP issues. They kept monitoring my heart and pressure. After 3 + hours things had went back to normal. On Friday, the day of the vaccine, I felt very heavy, tired and just out of it. I could just sleep after I got home. I finally started feeling like myself on the 03/16/2021,
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Tongue discomfort
Clinical narrative: Soon after vaccination was received my tongue started tingling and then went from tingling to feeling really heavy, and then I went to a place where I started feeling shortness of breath and very weak. I could not breath very well, the nurse on site gave me an Epi-Pen and it helped. I was transferred to ER at Hospital, where they monitored me and they told me my pressure was elevated. I don't have any HBP issues. They kept monitoring my heart and pressure. After 3 + hours things had went back to normal. On Friday, the day of the vaccine, I felt very heavy, tired and just out of it. I could just sleep after I got home. I finally started feeling like myself on the 03/16/2021,
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood alkaline phosphatase, Proteinuria, Urine analysis
Clinical narrative: 3/9/21 @ 11:14 dose #1 (Pfizer) Lot EN6206 -minimal soreness (site); very tired; slept rest of day 3/10/21  3/11/21 .. intermittent upper R/L flank "discomfort" 3/12/21: severe pain (10+)/20min/upper R internal, posterior (? Kidney); rpt to PCP; urinalysis: urine protein 1+; pH 9.0 (H) PCP suspect sx.. Pfizer vaccine 3/16/21: gradually lesser 3/19/21: f/u BMP: Na -143; CI 107 (H); K+ 5.5 (H) urine protein neg pH: 7.0
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood chloride, Blood potassium, Blood sodium, Fatigue, Nephrolithiasis
Clinical narrative: 3/9/21 @ 11:14 dose #1 (Pfizer) Lot EN6206 -minimal soreness (site); very tired; slept rest of day 3/10/21  3/11/21 .. intermittent upper R/L flank "discomfort" 3/12/21: severe pain (10+)/20min/upper R internal, posterior (? Kidney); rpt to PCP; urinalysis: urine protein 1+; pH 9.0 (H) PCP suspect sx.. Pfizer vaccine 3/16/21: gradually lesser 3/19/21: f/u BMP: Na -143; CI 107 (H); K+ 5.5 (H) urine protein neg pH: 7.0
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Protein urine, Urine analysis, Vaccination site pain
Clinical narrative: 3/9/21 @ 11:14 dose #1 (Pfizer) Lot EN6206 -minimal soreness (site); very tired; slept rest of day 3/10/21  3/11/21 .. intermittent upper R/L flank "discomfort" 3/12/21: severe pain (10+)/20min/upper R internal, posterior (? Kidney); rpt to PCP; urinalysis: urine protein 1+; pH 9.0 (H) PCP suspect sx.. Pfizer vaccine 3/16/21: gradually lesser 3/19/21: f/u BMP: Na -143; CI 107 (H); K+ 5.5 (H) urine protein neg pH: 7.0
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood chloride increased, Blood potassium increased, Blood sodium normal, Discomfort, Fatigue
Clinical narrative: 3/9/21 @ 11:14 dose #1 (Pfizer) Lot EN6206 -minimal soreness (site); very tired; slept rest of day 3/10/21  3/11/21 .. intermittent upper R/L flank "discomfort" 3/12/21: severe pain (10+)/20min/upper R internal, posterior (? Kidney); rpt to PCP; urinalysis: urine protein 1+; pH 9.0 (H) PCP suspect sx.. Pfizer vaccine 3/16/21: gradually lesser 3/19/21: f/u BMP: Na -143; CI 107 (H); K+ 5.5 (H) urine protein neg pH: 7.0
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pain, Metabolic function test, Pain, Protein urine, Protein urine absent
Clinical narrative: 3/9/21 @ 11:14 dose #1 (Pfizer) Lot EN6206 -minimal soreness (site); very tired; slept rest of day 3/10/21  3/11/21 .. intermittent upper R/L flank "discomfort" 3/12/21: severe pain (10+)/20min/upper R internal, posterior (? Kidney); rpt to PCP; urinalysis: urine protein 1+; pH 9.0 (H) PCP suspect sx.. Pfizer vaccine 3/16/21: gradually lesser 3/19/21: f/u BMP: Na -143; CI 107 (H); K+ 5.5 (H) urine protein neg pH: 7.0
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Renal pain, Somnolence, Urine analysis, pH urine increased
Clinical narrative: 3/9/21 @ 11:14 dose #1 (Pfizer) Lot EN6206 -minimal soreness (site); very tired; slept rest of day 3/10/21  3/11/21 .. intermittent upper R/L flank "discomfort" 3/12/21: severe pain (10+)/20min/upper R internal, posterior (? Kidney); rpt to PCP; urinalysis: urine protein 1+; pH 9.0 (H) PCP suspect sx.. Pfizer vaccine 3/16/21: gradually lesser 3/19/21: f/u BMP: Na -143; CI 107 (H); K+ 5.5 (H) urine protein neg pH: 7.0
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: 3/9/21 @ 11:14 dose #1 (Pfizer) Lot EN6206 -minimal soreness (site); very tired; slept rest of day 3/10/21  3/11/21 .. intermittent upper R/L flank "discomfort" 3/12/21: severe pain (10+)/20min/upper R internal, posterior (? Kidney); rpt to PCP; urinalysis: urine protein 1+; pH 9.0 (H) PCP suspect sx.. Pfizer vaccine 3/16/21: gradually lesser 3/19/21: f/u BMP: Na -143; CI 107 (H); K+ 5.5 (H) urine protein neg pH: 7.0
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiovascular disorder, Deep vein thrombosis, Pain in extremity, Peripheral swelling, Ultrasound Doppler abnormal
Clinical narrative: Right femoral: acute thrombosis; no compression; no flow detected; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 16Feb2021 08:00 AM (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. No known allergies. Other medical history: Left Leg DVT in 2010; Melanoma on nose. Other medications in two weeks included Atorvastatin, Finasteride,  multivitamin. The patient received first dose of BNT162B2 (lot number: EL9261) on 25Jan202113:45 PM in the right arm for Covid-19 Immunization. The patient experienced pain in upper right thigh on day after second vaccine, then on the third day after the second vaccine, diagnosed with a blood clot in the upper right thigh with badly swollen calf diagnosed as "Right femoral: acute thrombosis; no compression; no flow detected". Adverse event started on 17Feb2021 14:00 PM. AE resulted in: [Emergency room/department or urgent care, Hospitalization]. The event received treatment included Heparin IV followed by Eliquis. The patient was not recovered. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination included Nasal Swab with Negative result on 19Feb2021.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Venous thrombosis limb
Clinical narrative: Right femoral: acute thrombosis; no compression; no flow detected; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 16Feb2021 08:00 AM (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. No known allergies. Other medical history: Left Leg DVT in 2010; Melanoma on nose. Other medications in two weeks included Atorvastatin, Finasteride,  multivitamin. The patient received first dose of BNT162B2 (lot number: EL9261) on 25Jan202113:45 PM in the right arm for Covid-19 Immunization. The patient experienced pain in upper right thigh on day after second vaccine, then on the third day after the second vaccine, diagnosed with a blood clot in the upper right thigh with badly swollen calf diagnosed as "Right femoral: acute thrombosis; no compression; no flow detected". Adverse event started on 17Feb2021 14:00 PM. AE resulted in: [Emergency room/department or urgent care, Hospitalization]. The event received treatment included Heparin IV followed by Eliquis. The patient was not recovered. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination included Nasal Swab with Negative result on 19Feb2021.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient received Moderna Vaccine prior, and received Janssen vaccine as second dose
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient received Moderna Vaccine prior, and received Janssen vaccine as second dose
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bowel movement irregularity, Death, Decreased appetite, Defaecation disorder, Dyspnoea
Clinical narrative: pt had chills and nausea following vaccine- died 4 days after vaccine was given.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain
Clinical narrative: pt had chills and nausea following vaccine- died 4 days after vaccine was given.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Death, Nausea
Clinical narrative: pt had chills and nausea following vaccine- died 4 days after vaccine was given.