chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Body temperature, Chest X-ray, Chills, Computerised tomogram
Clinical narrative: Throat is closing; Left side of tongue felt swollen and numb; Chills; Feverish; Body Aches; Hands and feet numb; Facial Numbness and tingling; Facial Numbness and tingling; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 01Feb2021 11:00 (Batch/Lot Number: EL3249; Expiration Date: 31May2021) as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Left on 11Jan2021 07:00 (Batch/Lot Number: EL1284) as SINGLE DOSE for covid-19 immunisation. Medical history included vasculitis from an unknown date and unknown if ongoing Autoimmune called Behcet's which is part of vasculitis autoimmune diseases. Diagnosed 7-8 years ago.   There were no concomitant medications. The patient experienced facial numbness and tingling, feverish hands and feet numb, body aches ,chills throat tightness, left side of tongue felt swollen and numb. The outcome of all the events were recovering. When she went to the ER on 02Feb2021, they did a CT scan of her head to make sure it was not a stroke or Bell's Palsy. It was unremarkable and they did a workup of blood and urine, which did not show anything. They came to the conclusion that it was a vaccine reaction. They also did a Chest X-ray and a COVID test and she was negative for both.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Culture urine, Hypoaesthesia, Influenza, Pain, Paraesthesia
Clinical narrative: Throat is closing; Left side of tongue felt swollen and numb; Chills; Feverish; Body Aches; Hands and feet numb; Facial Numbness and tingling; Facial Numbness and tingling; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 01Feb2021 11:00 (Batch/Lot Number: EL3249; Expiration Date: 31May2021) as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Left on 11Jan2021 07:00 (Batch/Lot Number: EL1284) as SINGLE DOSE for covid-19 immunisation. Medical history included vasculitis from an unknown date and unknown if ongoing Autoimmune called Behcet's which is part of vasculitis autoimmune diseases. Diagnosed 7-8 years ago.   There were no concomitant medications. The patient experienced facial numbness and tingling, feverish hands and feet numb, body aches ,chills throat tightness, left side of tongue felt swollen and numb. The outcome of all the events were recovering. When she went to the ER on 02Feb2021, they did a CT scan of her head to make sure it was not a stroke or Bell's Palsy. It was unremarkable and they did a workup of blood and urine, which did not show anything. They came to the conclusion that it was a vaccine reaction. They also did a Chest X-ray and a COVID test and she was negative for both.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Swollen tongue, Throat tightness
Clinical narrative: Throat is closing; Left side of tongue felt swollen and numb; Chills; Feverish; Body Aches; Hands and feet numb; Facial Numbness and tingling; Facial Numbness and tingling; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 01Feb2021 11:00 (Batch/Lot Number: EL3249; Expiration Date: 31May2021) as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Left on 11Jan2021 07:00 (Batch/Lot Number: EL1284) as SINGLE DOSE for covid-19 immunisation. Medical history included vasculitis from an unknown date and unknown if ongoing Autoimmune called Behcet's which is part of vasculitis autoimmune diseases. Diagnosed 7-8 years ago.   There were no concomitant medications. The patient experienced facial numbness and tingling, feverish hands and feet numb, body aches ,chills throat tightness, left side of tongue felt swollen and numb. The outcome of all the events were recovering. When she went to the ER on 02Feb2021, they did a CT scan of her head to make sure it was not a stroke or Bell's Palsy. It was unremarkable and they did a workup of blood and urine, which did not show anything. They came to the conclusion that it was a vaccine reaction. They also did a Chest X-ray and a COVID test and she was negative for both.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Diarrhoea, Dysphagia, Erythema, Injection site erythema
Clinical narrative: I had hives. Vasculitis
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Ocular hyperaemia, Swelling face, Throat irritation, Urticaria
Clinical narrative: I had hives. Vasculitis
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Urticaria, Vasculitis
Clinical narrative: I had hives. Vasculitis
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for Covid on 6/17/21. Pt became symptomatic with the following symptoms: sinus congestions, rhinorrhea, and fatigue. Symptom onset was 6/17/21.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Fatigue, Rhinorrhoea, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: Patient tested positive for Covid on 6/17/21. Pt became symptomatic with the following symptoms: sinus congestions, rhinorrhea, and fatigue. Symptom onset was 6/17/21.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chills, Fatigue, Injection site pain, Pain in extremity
Clinical narrative: I started getting chills with uncontrollable shaking 8 hours later; I started getting chills with uncontrollable shaking 8 hours later; and had a fever 3 degrees more than normal; I was extremely fatigued; started feeling unwell; it progressed to extreme stomach pain; extreme arm pain (in the arm that didn't get the shot); This is a spontaneous report from a contactable consumer (Patient). A 57-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 11:30 AM (at the age of 57-years-old) as a single dose for covid-19 immunisation. Medical history included obesity. Concomitant medications included calcium, colecalciferol (CALCIUM +VIT D) and Multi-vitamin taken for an unspecified indication both received two weeks of vaccination. 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 receive any other vaccines within four weeks prior to the vaccination. Patient previously received Erythromycin and was allergic to it. Patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 24Jan2021 at 11:15 AM as a single dose for covid-19 immunisation. On 18Feb2021 at 06:30 PM, 31 hours after receiving the vaccine, patient started feeling unwell and it progressed to extreme stomach pain, and extreme arm pain (in the arm that did not get the shot). On 19Feb2021 at 02:30, she started getting chills with uncontrollable shaking 8 hours later and had a fever 3 degrees more than normal. The fever reduced 1 degree the following day, and 1 degree more the day after. The entire time she was extremely fatigued. By day 6, she felt fine. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: I started getting chills with uncontrollable shaking 8 hours later; I started getting chills with uncontrollable shaking 8 hours later; and had a fever 3 degrees more than normal; I was extremely fatigued; started feeling unwell; it progressed to extreme stomach pain; extreme arm pain (in the arm that didn't get the shot); This is a spontaneous report from a contactable consumer (Patient). A 57-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 11:30 AM (at the age of 57-years-old) as a single dose for covid-19 immunisation. Medical history included obesity. Concomitant medications included calcium, colecalciferol (CALCIUM +VIT D) and Multi-vitamin taken for an unspecified indication both received two weeks of vaccination. 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 receive any other vaccines within four weeks prior to the vaccination. Patient previously received Erythromycin and was allergic to it. Patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 24Jan2021 at 11:15 AM as a single dose for covid-19 immunisation. On 18Feb2021 at 06:30 PM, 31 hours after receiving the vaccine, patient started feeling unwell and it progressed to extreme stomach pain, and extreme arm pain (in the arm that did not get the shot). On 19Feb2021 at 02:30, she started getting chills with uncontrollable shaking 8 hours later and had a fever 3 degrees more than normal. The fever reduced 1 degree the following day, and 1 degree more the day after. The entire time she was extremely fatigued. By day 6, she felt fine. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Malaise, Pain in extremity
Clinical narrative: I started getting chills with uncontrollable shaking 8 hours later; I started getting chills with uncontrollable shaking 8 hours later; and had a fever 3 degrees more than normal; I was extremely fatigued; started feeling unwell; it progressed to extreme stomach pain; extreme arm pain (in the arm that didn't get the shot); This is a spontaneous report from a contactable consumer (Patient). A 57-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 11:30 AM (at the age of 57-years-old) as a single dose for covid-19 immunisation. Medical history included obesity. Concomitant medications included calcium, colecalciferol (CALCIUM +VIT D) and Multi-vitamin taken for an unspecified indication both received two weeks of vaccination. 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 receive any other vaccines within four weeks prior to the vaccination. Patient previously received Erythromycin and was allergic to it. Patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 24Jan2021 at 11:15 AM as a single dose for covid-19 immunisation. On 18Feb2021 at 06:30 PM, 31 hours after receiving the vaccine, patient started feeling unwell and it progressed to extreme stomach pain, and extreme arm pain (in the arm that did not get the shot). On 19Feb2021 at 02:30, she started getting chills with uncontrollable shaking 8 hours later and had a fever 3 degrees more than normal. The fever reduced 1 degree the following day, and 1 degree more the day after. The entire time she was extremely fatigued. By day 6, she felt fine. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: I started getting chills with uncontrollable shaking 8 hours later; I started getting chills with uncontrollable shaking 8 hours later; and had a fever 3 degrees more than normal; I was extremely fatigued; started feeling unwell; it progressed to extreme stomach pain; extreme arm pain (in the arm that didn't get the shot); This is a spontaneous report from a contactable consumer (Patient). A 57-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 11:30 AM (at the age of 57-years-old) as a single dose for covid-19 immunisation. Medical history included obesity. Concomitant medications included calcium, colecalciferol (CALCIUM +VIT D) and Multi-vitamin taken for an unspecified indication both received two weeks of vaccination. 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 receive any other vaccines within four weeks prior to the vaccination. Patient previously received Erythromycin and was allergic to it. Patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 24Jan2021 at 11:15 AM as a single dose for covid-19 immunisation. On 18Feb2021 at 06:30 PM, 31 hours after receiving the vaccine, patient started feeling unwell and it progressed to extreme stomach pain, and extreme arm pain (in the arm that did not get the shot). On 19Feb2021 at 02:30, she started getting chills with uncontrollable shaking 8 hours later and had a fever 3 degrees more than normal. The fever reduced 1 degree the following day, and 1 degree more the day after. The entire time she was extremely fatigued. By day 6, she felt fine. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pruritus, Pruritus, Rash
Clinical narrative: I had the vaccine and 29 minutes later I started getting itchy, it started on the top of my head and moved down my body, I started getting a rash, the back of my throat was itchy. Before that I was feeling very hot and I let the nurse know and they gave me 50 mg of Benadryl intramuscular shot. They let me go home.  I contacted my doctor and she said that I should have been sent to the ER but I did not go since I was already at home. After a couple hours I did not feel super itchy it was just a little itchy for 2 days after maybe and I was definitely tired for a few days.  I had my normal Dermatomyositis treatment and I still continue with this fatigued and brain fog.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein normal, Differential white blood cell count normal, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: I had the vaccine and 29 minutes later I started getting itchy, it started on the top of my head and moved down my body, I started getting a rash, the back of my throat was itchy. Before that I was feeling very hot and I let the nurse know and they gave me 50 mg of Benadryl intramuscular shot. They let me go home.  I contacted my doctor and she said that I should have been sent to the ER but I did not go since I was already at home. After a couple hours I did not feel super itchy it was just a little itchy for 2 days after maybe and I was definitely tired for a few days.  I had my normal Dermatomyositis treatment and I still continue with this fatigued and brain fog.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Hepatitis viral test negative, Magnetic resonance imaging head, Pruritus, Rash
Clinical narrative: I had the vaccine and 29 minutes later I started getting itchy, it started on the top of my head and moved down my body, I started getting a rash, the back of my throat was itchy. Before that I was feeling very hot and I let the nurse know and they gave me 50 mg of Benadryl intramuscular shot. They let me go home.  I contacted my doctor and she said that I should have been sent to the ER but I did not go since I was already at home. After a couple hours I did not feel super itchy it was just a little itchy for 2 days after maybe and I was definitely tired for a few days.  I had my normal Dermatomyositis treatment and I still continue with this fatigued and brain fog.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Thyroid function test normal, Tuberculin test negative, Vitamin B12 normal, Vitamin D
Clinical narrative: I had the vaccine and 29 minutes later I started getting itchy, it started on the top of my head and moved down my body, I started getting a rash, the back of my throat was itchy. Before that I was feeling very hot and I let the nurse know and they gave me 50 mg of Benadryl intramuscular shot. They let me go home.  I contacted my doctor and she said that I should have been sent to the ER but I did not go since I was already at home. After a couple hours I did not feel super itchy it was just a little itchy for 2 days after maybe and I was definitely tired for a few days.  I had my normal Dermatomyositis treatment and I still continue with this fatigued and brain fog.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immune thrombocytopenia
Clinical narrative: When I got the shot, I immediately had a burning fire sensation through my left arm. It got more and more intense as we left and went home. At the point where I had to go to the hospital was 3 days later. I broke out in a rash of pinprick blood spots all over my body.  immune thrombocytopenia Where my blood platelets dropped. I looked like I was bleeding under my skin. My blood count dropped by at least 200-300. It was not so bad that I had to have a transfusion. It started me into a downward spiral of all my autoimmune system flaring. My dermatomyositis has really heightened. Up my neck, into my face was a deep red/scarlet. I felt like it triggered a flare in all my autoimmune issues. It took about 4 weeks from there for me to get better but months later, I have not regained the level of health I had prior to 3/15, when I received the vaccine. Last month I began taking a new immunosuppressant drug.   I have pictures of the pinprick rash that appeared on my body.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: When I got the shot, I immediately had a burning fire sensation through my left arm. It got more and more intense as we left and went home. At the point where I had to go to the hospital was 3 days later. I broke out in a rash of pinprick blood spots all over my body.  immune thrombocytopenia Where my blood platelets dropped. I looked like I was bleeding under my skin. My blood count dropped by at least 200-300. It was not so bad that I had to have a transfusion. It started me into a downward spiral of all my autoimmune system flaring. My dermatomyositis has really heightened. Up my neck, into my face was a deep red/scarlet. I felt like it triggered a flare in all my autoimmune issues. It took about 4 weeks from there for me to get better but months later, I have not regained the level of health I had prior to 3/15, when I received the vaccine. Last month I began taking a new immunosuppressant drug.   I have pictures of the pinprick rash that appeared on my body.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Burning sensation, Condition aggravated, Dermatomyositis, Erythema
Clinical narrative: When I got the shot, I immediately had a burning fire sensation through my left arm. It got more and more intense as we left and went home. At the point where I had to go to the hospital was 3 days later. I broke out in a rash of pinprick blood spots all over my body.  immune thrombocytopenia Where my blood platelets dropped. I looked like I was bleeding under my skin. My blood count dropped by at least 200-300. It was not so bad that I had to have a transfusion. It started me into a downward spiral of all my autoimmune system flaring. My dermatomyositis has really heightened. Up my neck, into my face was a deep red/scarlet. I felt like it triggered a flare in all my autoimmune issues. It took about 4 weeks from there for me to get better but months later, I have not regained the level of health I had prior to 3/15, when I received the vaccine. Last month I began taking a new immunosuppressant drug.   I have pictures of the pinprick rash that appeared on my body.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Immune thrombocytopenia, Platelet count decreased, Rash, Rash macular
Clinical narrative: When I got the shot, I immediately had a burning fire sensation through my left arm. It got more and more intense as we left and went home. At the point where I had to go to the hospital was 3 days later. I broke out in a rash of pinprick blood spots all over my body.  immune thrombocytopenia Where my blood platelets dropped. I looked like I was bleeding under my skin. My blood count dropped by at least 200-300. It was not so bad that I had to have a transfusion. It started me into a downward spiral of all my autoimmune system flaring. My dermatomyositis has really heightened. Up my neck, into my face was a deep red/scarlet. I felt like it triggered a flare in all my autoimmune issues. It took about 4 weeks from there for me to get better but months later, I have not regained the level of health I had prior to 3/15, when I received the vaccine. Last month I began taking a new immunosuppressant drug.   I have pictures of the pinprick rash that appeared on my body.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema, Swollen tongue
Clinical narrative: severe hives on her upper right thigh; redness at shot site; anaphylaxis; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:00 (Lot Number: EN6026) at the age of 71-year-old as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history included ongoing High blood pressure, but nothing else and have not had adverse reactions to any vaccines. She had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and since the vaccination, the patient has not been tested for COVID-19.Concomitant medications included lisinopril; nebivolol hydrochloride (BYSTOLIC); amlodipine besilate all taken for an unspecified indication, start and stop date were not reported. The patient reported on 01Apr2021, she developed anaphylaxis prior to her 2nd shot and was taken by ambulance to emergency room. On 30May2021 11:00 AM, she developed a severe hives on her upper right thigh and redness at shot site. She has never had hives before and it has been 3 days and they were still pretty severe. She was concerned there was a correlation between her shot, her anaphylactic reaction and this event. The outcome of the events was resolving. There was no treatment received.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: severe hives on her upper right thigh; redness at shot site; anaphylaxis; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:00 (Lot Number: EN6026) at the age of 71-year-old as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history included ongoing High blood pressure, but nothing else and have not had adverse reactions to any vaccines. She had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and since the vaccination, the patient has not been tested for COVID-19.Concomitant medications included lisinopril; nebivolol hydrochloride (BYSTOLIC); amlodipine besilate all taken for an unspecified indication, start and stop date were not reported. The patient reported on 01Apr2021, she developed anaphylaxis prior to her 2nd shot and was taken by ambulance to emergency room. On 30May2021 11:00 AM, she developed a severe hives on her upper right thigh and redness at shot site. She has never had hives before and it has been 3 days and they were still pretty severe. She was concerned there was a correlation between her shot, her anaphylactic reaction and this event. The outcome of the events was resolving. There was no treatment received.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Urticaria, Vaccination site erythema
Clinical narrative: severe hives on her upper right thigh; redness at shot site; anaphylaxis; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:00 (Lot Number: EN6026) at the age of 71-year-old as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history included ongoing High blood pressure, but nothing else and have not had adverse reactions to any vaccines. She had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and since the vaccination, the patient has not been tested for COVID-19.Concomitant medications included lisinopril; nebivolol hydrochloride (BYSTOLIC); amlodipine besilate all taken for an unspecified indication, start and stop date were not reported. The patient reported on 01Apr2021, she developed anaphylaxis prior to her 2nd shot and was taken by ambulance to emergency room. On 30May2021 11:00 AM, she developed a severe hives on her upper right thigh and redness at shot site. She has never had hives before and it has been 3 days and they were still pretty severe. She was concerned there was a correlation between her shot, her anaphylactic reaction and this event. The outcome of the events was resolving. There was no treatment received.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Facial paralysis, Magnetic resonance imaging
Clinical narrative: Bell's palsy; Facial paralysis; This case was received via FDA VAERS (Reference number: 1176965) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by a patient and describes the occurrence of BELL'S PALSY (Bell's palsy) and FACIAL PARALYSIS (Facial paralysis) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. SPY/HLM/HLM/) for COVID-19 vaccination.     The patient's past medical history included GERD. Concurrent medical conditions included Penicillin allergy and Blood pressure high. Concomitant products included PANTOPRAZOLE, RIVAROXABAN (XARELTO) and DILTIAZEM HYDROCHLORIDE (CARDIZEM CD) for an unknown indication, VALSARTAN (DIOVAN) and HYDROXOCOBALAMIN (VITAMIN B12 [HYDROXOCOBALAMIN]).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant) and FACIAL PARALYSIS (Facial paralysis) (seriousness criterion medically significant). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's palsy) and FACIAL PARALYSIS (Facial paralysis) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other medications include Multivitamins and Probiotics.  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.; Sender'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: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Bell's palsy; Facial paralysis; This case was received via FDA VAERS (Reference number: 1176965) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by a patient and describes the occurrence of BELL'S PALSY (Bell's palsy) and FACIAL PARALYSIS (Facial paralysis) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. SPY/HLM/HLM/) for COVID-19 vaccination.     The patient's past medical history included GERD. Concurrent medical conditions included Penicillin allergy and Blood pressure high. Concomitant products included PANTOPRAZOLE, RIVAROXABAN (XARELTO) and DILTIAZEM HYDROCHLORIDE (CARDIZEM CD) for an unknown indication, VALSARTAN (DIOVAN) and HYDROXOCOBALAMIN (VITAMIN B12 [HYDROXOCOBALAMIN]).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant) and FACIAL PARALYSIS (Facial paralysis) (seriousness criterion medically significant). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's palsy) and FACIAL PARALYSIS (Facial paralysis) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other medications include Multivitamins and Probiotics.  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.; Sender'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: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Dry eye, Ocular discomfort, Ocular hyperaemia
Clinical narrative: Severe eye pain; difficulty seeing; This is a spontaneous report received from a contactable consumer. This 18-years-old male consumer (patient) reported for himself that he received the first dose of BNT162B2 (lot number: EW0171) at single dose for COVID-19 immunisation on 08Apr2021.  Relevant medical history included tumor in leg when young. Known allergies: not aware off but had food allergies in childhood. Relevant concomitant drug was unknown.  The patient experienced severe eye pain, difficulty seeing after the first vaccination on 08Apr2021. The patient received antibiotic for the eye. Outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19.       Follow-up attempts are needed. Further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye pain, SARS-CoV-2 test, Visual acuity reduced
Clinical narrative: Severe eye pain; difficulty seeing; This is a spontaneous report received from a contactable consumer. This 18-years-old male consumer (patient) reported for himself that he received the first dose of BNT162B2 (lot number: EW0171) at single dose for COVID-19 immunisation on 08Apr2021.  Relevant medical history included tumor in leg when young. Known allergies: not aware off but had food allergies in childhood. Relevant concomitant drug was unknown.  The patient experienced severe eye pain, difficulty seeing after the first vaccination on 08Apr2021. The patient received antibiotic for the eye. Outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19.       Follow-up attempts are needed. Further information is expected.
Age: 46.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Back pain, Influenza like illness, Neck pain, Oropharyngeal pain, Rash
Clinical narrative: Rash on face; I have allergy issue; Lot of it has to do with skin reactions; Feeling a little tightness of the throat; Feel the ache; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient) or other non hcp.   A 46-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0169 and Expiration date: unknown), dose 1 via an unspecified route of administration on 27Apr2021 (at the age of 46-years-old) as first dose single dose for covid-19 immunisation. Medical history included blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (ASPIRINE) taken for an unspecified indication, start and stop date were not reported. On 28 Apr2021 patient experienced Lot of it has to do with skin reactions, a little tightness of the throat, feel the ache, flu like symptoms, have allergy issue. patient experienced a rash on the face on 28 Apr2021. it was reported that a lot of it has to do with skin reactions, patient was not sure if that was anything listed or anything that some may be not the majority people which already had experience but did want to get better information on it. Wanted to make sure that it was one not strange or out of the ordinary because another people had the same shot administered but everyone body was different. patient was feeling a little tightness of the throat and had allergy issue (further clarification unknown), patient was carrying an EpiPen, so they monitored after the shot and consumer seems fine. It was not directly after, but it was the next day that consumer started to feel the ache, more like a body response, flu like symptoms. But next day, woke up with a rash on the face not on the arm or the injection site and so consumer just wanted to make sure that was something if supposed to be mentioning to someone or something that consumer can continue to process the vaccination even with the rash. Confided if it was the first shot of Pfizer COVID 19 Vaccine, consumer stated, that was the first shot, and this was not the third day and the rash appeared on the third day after the shot of administered. Patient received treatment for the events as Tylenol 1000 mg, once. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Influenza like illness, Pain, Rash, Skin reaction
Clinical narrative: Rash on face; I have allergy issue; Lot of it has to do with skin reactions; Feeling a little tightness of the throat; Feel the ache; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient) or other non hcp.   A 46-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0169 and Expiration date: unknown), dose 1 via an unspecified route of administration on 27Apr2021 (at the age of 46-years-old) as first dose single dose for covid-19 immunisation. Medical history included blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (ASPIRINE) taken for an unspecified indication, start and stop date were not reported. On 28 Apr2021 patient experienced Lot of it has to do with skin reactions, a little tightness of the throat, feel the ache, flu like symptoms, have allergy issue. patient experienced a rash on the face on 28 Apr2021. it was reported that a lot of it has to do with skin reactions, patient was not sure if that was anything listed or anything that some may be not the majority people which already had experience but did want to get better information on it. Wanted to make sure that it was one not strange or out of the ordinary because another people had the same shot administered but everyone body was different. patient was feeling a little tightness of the throat and had allergy issue (further clarification unknown), patient was carrying an EpiPen, so they monitored after the shot and consumer seems fine. It was not directly after, but it was the next day that consumer started to feel the ache, more like a body response, flu like symptoms. But next day, woke up with a rash on the face not on the arm or the injection site and so consumer just wanted to make sure that was something if supposed to be mentioning to someone or something that consumer can continue to process the vaccination even with the rash. Confided if it was the first shot of Pfizer COVID 19 Vaccine, consumer stated, that was the first shot, and this was not the third day and the rash appeared on the third day after the shot of administered. Patient received treatment for the events as Tylenol 1000 mg, once. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Rash on face; I have allergy issue; Lot of it has to do with skin reactions; Feeling a little tightness of the throat; Feel the ache; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient) or other non hcp.   A 46-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0169 and Expiration date: unknown), dose 1 via an unspecified route of administration on 27Apr2021 (at the age of 46-years-old) as first dose single dose for covid-19 immunisation. Medical history included blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (ASPIRINE) taken for an unspecified indication, start and stop date were not reported. On 28 Apr2021 patient experienced Lot of it has to do with skin reactions, a little tightness of the throat, feel the ache, flu like symptoms, have allergy issue. patient experienced a rash on the face on 28 Apr2021. it was reported that a lot of it has to do with skin reactions, patient was not sure if that was anything listed or anything that some may be not the majority people which already had experience but did want to get better information on it. Wanted to make sure that it was one not strange or out of the ordinary because another people had the same shot administered but everyone body was different. patient was feeling a little tightness of the throat and had allergy issue (further clarification unknown), patient was carrying an EpiPen, so they monitored after the shot and consumer seems fine. It was not directly after, but it was the next day that consumer started to feel the ache, more like a body response, flu like symptoms. But next day, woke up with a rash on the face not on the arm or the injection site and so consumer just wanted to make sure that was something if supposed to be mentioning to someone or something that consumer can continue to process the vaccination even with the rash. Confided if it was the first shot of Pfizer COVID 19 Vaccine, consumer stated, that was the first shot, and this was not the third day and the rash appeared on the third day after the shot of administered. Patient received treatment for the events as Tylenol 1000 mg, once. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Dyspepsia, Headache, Heart rate normal
Clinical narrative: Two days after receiving the first Pfizer Covid vaccine, I began to feel intermittent tightness in my chest, which radiated to my shoulder area.   The tightness was mostly concentrated to my sternum area.  It was very scary and lasted approximately 2 to 3 weeks, however, when I spoke with a representative of Pfizer, they told me at the time that "they hadn't heard of any chest tightness reports."  Even though, I had never experienced chest pain before, I thought that perhaps it was related to stress.  Several weeks later, I heard reports of other people who experienced chest tightness like mine after receiving the vaccine, and there were also reports of myocarditis and pericarditis.   This news of heart problems related to the vaccine, prompted me to call my PCP.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Stress, Weight fluctuation
Clinical narrative: Two days after receiving the first Pfizer Covid vaccine, I began to feel intermittent tightness in my chest, which radiated to my shoulder area.   The tightness was mostly concentrated to my sternum area.  It was very scary and lasted approximately 2 to 3 weeks, however, when I spoke with a representative of Pfizer, they told me at the time that "they hadn't heard of any chest tightness reports."  Even though, I had never experienced chest pain before, I thought that perhaps it was related to stress.  Several weeks later, I heard reports of other people who experienced chest tightness like mine after receiving the vaccine, and there were also reports of myocarditis and pericarditis.   This news of heart problems related to the vaccine, prompted me to call my PCP.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Musculoskeletal discomfort
Clinical narrative: Two days after receiving the first Pfizer Covid vaccine, I began to feel intermittent tightness in my chest, which radiated to my shoulder area.   The tightness was mostly concentrated to my sternum area.  It was very scary and lasted approximately 2 to 3 weeks, however, when I spoke with a representative of Pfizer, they told me at the time that "they hadn't heard of any chest tightness reports."  Even though, I had never experienced chest pain before, I thought that perhaps it was related to stress.  Several weeks later, I heard reports of other people who experienced chest tightness like mine after receiving the vaccine, and there were also reports of myocarditis and pericarditis.   This news of heart problems related to the vaccine, prompted me to call my PCP.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram abdomen normal, Diarrhoea, Dizziness, Injection site pain
Clinical narrative: I start feeling not well that night, I started having bad muscle aches, nauseated, dizziness, light headed. I felt extremely fatigued. I tried to sleep and next day I had diarrhea. Everything I ate didn't stay in my body. I took ibuprofen. I called my neurologist, he had me call my primary doctor. I called my primary on Tuesday, my gums started bleeding and I had a rash. My primary told me to call back if symptoms continue. I called my primary on Friday he had me go to the ER. I went  Health clinic at town.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: I start feeling not well that night, I started having bad muscle aches, nauseated, dizziness, light headed. I felt extremely fatigued. I tried to sleep and next day I had diarrhea. Everything I ate didn't stay in my body. I took ibuprofen. I called my neurologist, he had me call my primary doctor. I called my primary on Tuesday, my gums started bleeding and I had a rash. My primary told me to call back if symptoms continue. I called my primary on Friday he had me go to the ER. I went  Health clinic at town.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Diarrhoea, Dizziness, Fatigue
Clinical narrative: I start feeling not well that night, I started having bad muscle aches, nauseated, dizziness, light headed. I felt extremely fatigued. I tried to sleep and next day I had diarrhea. Everything I ate didn't stay in my body. I took ibuprofen. I called my neurologist, he had me call my primary doctor. I called my primary on Tuesday, my gums started bleeding and I had a rash. My primary told me to call back if symptoms continue. I called my primary on Friday he had me go to the ER. I went  Health clinic at town.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gingival bleeding, Myalgia, Nausea
Clinical narrative: I start feeling not well that night, I started having bad muscle aches, nauseated, dizziness, light headed. I felt extremely fatigued. I tried to sleep and next day I had diarrhea. Everything I ate didn't stay in my body. I took ibuprofen. I called my neurologist, he had me call my primary doctor. I called my primary on Tuesday, my gums started bleeding and I had a rash. My primary told me to call back if symptoms continue. I called my primary on Friday he had me go to the ER. I went  Health clinic at town.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Pericardial effusion
Clinical narrative: Pericardial Effusion and tamponade
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac tamponade, Computerised tomogram, Echocardiogram, Pericardial effusion
Clinical narrative: Pericardial Effusion and tamponade
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Epstein-Barr virus test, Fatigue, Grip strength decreased, Headache
Clinical narrative: ruptured ovarian cyst; allergic to naproxen; Muscle weakness; loss of some motor function; easy fatigue; muscle pain; cluster headache; endometriosis flare up; headaches; dizzy/ lightheaded; confusion; Brain fog; nauseaus; This is a spontaneous report received from a contactable Other HCP (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Apr2021 11:00 (at 29-year-old) (Lot Number: EW0175) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included endometriosis (now been diagnosed with cluster headaches and a ruptured ovarian cyst. Other symptoms not diagnosed yet). She's never been allergic to anything before vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19 Concomitant medications included daily escitalopram and quetiapine fumarate (SEROQUEL) for years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021 06:00 am, the patient experienced muscle weakness, loss of some motor function, easy fatigue, muscle pain, cluster headache, endometriosis flare up, ruptured ovarian cyst, headaches, lightheaded, dizzy, nauseaus, allergic to naproxen when she's never been allergic to anything before, brain fog, and confusion. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. No treatment received for events. Since the vaccination, the patient has been tested (nasal swab on 05May2021) negative for COVID-19. The outcomes of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.