chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Pericardial effusion, Pleural effusion
Clinical narrative: Pericardial effusion; Pleural effusion; This case was received via FDA VAERS on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of PERICARDIAL EFFUSION (Pericardial effusion) and PLEURAL EFFUSION (Pleural effusion) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thoracentesis (Had 3 thoracentesis, one on 08APR 2021 (800ccs fluid removed) , second on 19APR2021 (1400 ccs fluid removed) and third on 26APR2021 (1500 ccs fluid removed).) from 08-Apr-2021 to 26-Apr-2021. Concomitant products included AMLODIPINE;BENAZEPRIL, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 08-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PERICARDIAL EFFUSION (Pericardial effusion) (seriousness criteria hospitalization and medically significant) and PLEURAL EFFUSION (Pleural effusion) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 13-Mar-2021 to 22-Mar-2021 due to PERICARDIAL EFFUSION and PLEURAL EFFUSION. At the time of the report, PERICARDIAL EFFUSION (Pericardial effusion) and PLEURAL EFFUSION (Pleural effusion) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Aspiration pleural cavity: no details (Inconclusive) No details. On 11-Mar-2021, Blood test: no result (Inconclusive) No result. On 11-Mar-2021, Catheterisation cardiac: no result (Inconclusive) No result. On 11-Mar-2021, Chest X-ray: effusion (abnormal) Pericardial and pleural effusion. On 11-Mar-2021, Echocardiogram: abnormal (abnormal) Abnormal. On 11-Mar-2021, Magnetic resonance imaging heart: effusion (abnormal) Pleural and pericardial effusion.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication provided.  Patient mentioned having multiple thoracentesis procedures, and had another session planned with thoracic surgeon.  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: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Deafness unilateral, Tinnitus
Clinical narrative: Deafness unilateral; Tinnitus; This case was received via FDA VAERS (Reference number: 1269427) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021    This regulatory authority case was reported by an other health care professional and describes the occurrence of DEAFNESS UNILATERAL (Deafness unilateral) and TINNITUS (Tinnitus) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Deafness unilateral) (seriousness criteria disability and medically significant) and TINNITUS (Tinnitus) (seriousness criterion disability). At the time of the report, DEAFNESS UNILATERAL (Deafness unilateral) and TINNITUS (Tinnitus) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported/unknown. Action taken with mRNA-1273 in response to the events was not Applicable. On 14-APR-2021, the patient had an audiology screening but no results were reported.  Company Comment: Very limited information regarding these events has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Deafness unilateral; Tinnitus; This case was received via FDA VAERS (Reference number: 1269427) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021    This regulatory authority case was reported by an other health care professional and describes the occurrence of DEAFNESS UNILATERAL (Deafness unilateral) and TINNITUS (Tinnitus) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Deafness unilateral) (seriousness criteria disability and medically significant) and TINNITUS (Tinnitus) (seriousness criterion disability). At the time of the report, DEAFNESS UNILATERAL (Deafness unilateral) and TINNITUS (Tinnitus) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported/unknown. Action taken with mRNA-1273 in response to the events was not Applicable. On 14-APR-2021, the patient had an audiology screening but no results were reported.  Company Comment: Very limited information regarding these events has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood glucose normal, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: I went to rest the 15 minutes they ask for and I felt a pain in my back, a little dizzy, feeling hot. They took my blood pressure and it was high (135/138) and they told me to go to the Emergency Department. When I went to the emergency room, the potassium was low. I have been very sleepy, tired and with chills and dizziness with nausea. I had a severe headache. I stayed for a couple of hours, they gave me IV fluids and advised me to go see a Cardiologist.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus tachycardia
Clinical narrative: I went to rest the 15 minutes they ask for and I felt a pain in my back, a little dizzy, feeling hot. They took my blood pressure and it was high (135/138) and they told me to go to the Emergency Department. When I went to the emergency room, the potassium was low. I have been very sleepy, tired and with chills and dizziness with nausea. I had a severe headache. I stayed for a couple of hours, they gave me IV fluids and advised me to go see a Cardiologist.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood potassium decreased, Chills, Dizziness, Fatigue
Clinical narrative: I went to rest the 15 minutes they ask for and I felt a pain in my back, a little dizzy, feeling hot. They took my blood pressure and it was high (135/138) and they told me to go to the Emergency Department. When I went to the emergency room, the potassium was low. I have been very sleepy, tired and with chills and dizziness with nausea. I had a severe headache. I stayed for a couple of hours, they gave me IV fluids and advised me to go see a Cardiologist.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Headache, Laboratory test, Nausea, Somnolence
Clinical narrative: I went to rest the 15 minutes they ask for and I felt a pain in my back, a little dizzy, feeling hot. They took my blood pressure and it was high (135/138) and they told me to go to the Emergency Department. When I went to the emergency room, the potassium was low. I have been very sleepy, tired and with chills and dizziness with nausea. I had a severe headache. I stayed for a couple of hours, they gave me IV fluids and advised me to go see a Cardiologist.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Eye movement disorder, Fear of injection, Incoherent
Clinical narrative: Following with reaction like seizure; And after that faint; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; This is a spontaneous report received from a contactable consumer (patient).  A 16-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19May2021 at 15:45 at single dose in left arm for COVID-19 immunisation at the age of 16-year-old. Lot number was Er8735. Medical history included Environmental allergies. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000). On 19May2021 at 04:45, the patient experienced chest, neck and head pain with a burning sensation. Following with reaction like seizure. Then, patient started to change the face skin color, cold skin, and memory loss. And after that he faint. The patient was not treated for the events. The patient recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Nervousness, Tremor
Clinical narrative: Following with reaction like seizure; And after that faint; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; This is a spontaneous report received from a contactable consumer (patient).  A 16-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19May2021 at 15:45 at single dose in left arm for COVID-19 immunisation at the age of 16-year-old. Lot number was Er8735. Medical history included Environmental allergies. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000). On 19May2021 at 04:45, the patient experienced chest, neck and head pain with a burning sensation. Following with reaction like seizure. Then, patient started to change the face skin color, cold skin, and memory loss. And after that he faint. The patient was not treated for the events. The patient recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Chest pain, Cold sweat, Headache, Neck pain
Clinical narrative: Following with reaction like seizure; And after that faint; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; This is a spontaneous report received from a contactable consumer (patient).  A 16-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19May2021 at 15:45 at single dose in left arm for COVID-19 immunisation at the age of 16-year-old. Lot number was Er8735. Medical history included Environmental allergies. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000). On 19May2021 at 04:45, the patient experienced chest, neck and head pain with a burning sensation. Following with reaction like seizure. Then, patient started to change the face skin color, cold skin, and memory loss. And after that he faint. The patient was not treated for the events. The patient recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure, Skin discolouration, Syncope
Clinical narrative: Following with reaction like seizure; And after that faint; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; This is a spontaneous report received from a contactable consumer (patient).  A 16-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19May2021 at 15:45 at single dose in left arm for COVID-19 immunisation at the age of 16-year-old. Lot number was Er8735. Medical history included Environmental allergies. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000). On 19May2021 at 04:45, the patient experienced chest, neck and head pain with a burning sensation. Following with reaction like seizure. Then, patient started to change the face skin color, cold skin, and memory loss. And after that he faint. The patient was not treated for the events. The patient recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Imaging procedure, Lipase increased, Pancreatitis acute
Clinical narrative: Pancreatitis acute; This case was received via FDA VAERS (Reference number: 1334382) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.   This regulatory authority case was reported by an other health care professional and describes the occurrence of PANCREATITIS ACUTE (Pancreatitis acute) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PANCREATITIS ACUTE (Pancreatitis acute) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, PANCREATITIS ACUTE (Pancreatitis acute) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Blood test abnormal: abnormal (abnormal) abnormal. On 07-Mar-2021, Imaging procedure: inconclusive (Inconclusive) inconclusive. On 07-Mar-2021, Lipase increased: increased (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary normal, Arteriogram coronary normal, Asthenia, Cardiac ventriculogram left normal, Catheterisation cardiac
Clinical narrative: Patient is a 53 y.o. male with no known past medical history, who was admitted to the hospital on 5/19/2021 with chest pain.    Patient presented for worsening generalized muscle pain and weakness for the past 2 weeks. He received the J&J vaccine 3 weeks ago and symptoms began 8 days later. He developed chest pain this morning which has progressively worsened throughout the day. The chest pain is substernal and right sided, no radiation. Characterized as squeezing, pressure-like pain. Pain is relieved by sitting and standing, worse with laying flat and inspiration. Denies similar pain in the past. Denies any cardiac history.   In the ED, his BP was 141/73, HR 116, RR 20, T 97.6, SpO2 100% on RA. EKG showed showed STE in V5-V6 with depression in aVL. Initially given aspirin 325mg. D-dimer found to be elevated and underwent CTA chest which was negative for PE. Troponin 0.27 -> 0.4 -> 0.35. No progressive changes on follow EKGs, however given no improvement in chest pain after SL nitro and nitro gtt, cardiac alert was called.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Electrocardiogram ST segment elevation, Electrocardiogram normal, Fibrin D dimer increased, Myalgia
Clinical narrative: Patient is a 53 y.o. male with no known past medical history, who was admitted to the hospital on 5/19/2021 with chest pain.    Patient presented for worsening generalized muscle pain and weakness for the past 2 weeks. He received the J&J vaccine 3 weeks ago and symptoms began 8 days later. He developed chest pain this morning which has progressively worsened throughout the day. The chest pain is substernal and right sided, no radiation. Characterized as squeezing, pressure-like pain. Pain is relieved by sitting and standing, worse with laying flat and inspiration. Denies similar pain in the past. Denies any cardiac history.   In the ED, his BP was 141/73, HR 116, RR 20, T 97.6, SpO2 100% on RA. EKG showed showed STE in V5-V6 with depression in aVL. Initially given aspirin 325mg. D-dimer found to be elevated and underwent CTA chest which was negative for PE. Troponin 0.27 -> 0.4 -> 0.35. No progressive changes on follow EKGs, however given no improvement in chest pain after SL nitro and nitro gtt, cardiac alert was called.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericarditis, Pleuritic pain, Troponin increased
Clinical narrative: Patient is a 53 y.o. male with no known past medical history, who was admitted to the hospital on 5/19/2021 with chest pain.    Patient presented for worsening generalized muscle pain and weakness for the past 2 weeks. He received the J&J vaccine 3 weeks ago and symptoms began 8 days later. He developed chest pain this morning which has progressively worsened throughout the day. The chest pain is substernal and right sided, no radiation. Characterized as squeezing, pressure-like pain. Pain is relieved by sitting and standing, worse with laying flat and inspiration. Denies similar pain in the past. Denies any cardiac history.   In the ED, his BP was 141/73, HR 116, RR 20, T 97.6, SpO2 100% on RA. EKG showed showed STE in V5-V6 with depression in aVL. Initially given aspirin 325mg. D-dimer found to be elevated and underwent CTA chest which was negative for PE. Troponin 0.27 -> 0.4 -> 0.35. No progressive changes on follow EKGs, however given no improvement in chest pain after SL nitro and nitro gtt, cardiac alert was called.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary normal, Asthenia, Chest discomfort, Chest pain, Electrocardiogram ST segment depression
Clinical narrative: Patient is a 53 y.o. male with no known past medical history, who was admitted to the hospital on 5/19/2021 with chest pain.    Patient presented for worsening generalized muscle pain and weakness for the past 2 weeks. He received the J&J vaccine 3 weeks ago and symptoms began 8 days later. He developed chest pain this morning which has progressively worsened throughout the day. The chest pain is substernal and right sided, no radiation. Characterized as squeezing, pressure-like pain. Pain is relieved by sitting and standing, worse with laying flat and inspiration. Denies similar pain in the past. Denies any cardiac history.   In the ED, his BP was 141/73, HR 116, RR 20, T 97.6, SpO2 100% on RA. EKG showed showed STE in V5-V6 with depression in aVL. Initially given aspirin 325mg. D-dimer found to be elevated and underwent CTA chest which was negative for PE. Troponin 0.27 -> 0.4 -> 0.35. No progressive changes on follow EKGs, however given no improvement in chest pain after SL nitro and nitro gtt, cardiac alert was called.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, Myalgia, Pleuritic pain, Troponin
Clinical narrative: Patient is a 53 y.o. male with no known past medical history, who was admitted to the hospital on 5/19/2021 with chest pain.    Patient presented for worsening generalized muscle pain and weakness for the past 2 weeks. He received the J&J vaccine 3 weeks ago and symptoms began 8 days later. He developed chest pain this morning which has progressively worsened throughout the day. The chest pain is substernal and right sided, no radiation. Characterized as squeezing, pressure-like pain. Pain is relieved by sitting and standing, worse with laying flat and inspiration. Denies similar pain in the past. Denies any cardiac history.   In the ED, his BP was 141/73, HR 116, RR 20, T 97.6, SpO2 100% on RA. EKG showed showed STE in V5-V6 with depression in aVL. Initially given aspirin 325mg. D-dimer found to be elevated and underwent CTA chest which was negative for PE. Troponin 0.27 -> 0.4 -> 0.35. No progressive changes on follow EKGs, however given no improvement in chest pain after SL nitro and nitro gtt, cardiac alert was called.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cognitive disorder, Diplopia, IVth nerve paralysis, Lacunar infarction, Lacunar stroke
Clinical narrative: IVth nerve paralysis; Lacunar stroke; Lacunar infarction; Cognitive disorder; Diplopia; This case was received via VAERS (Reference number: 1350072) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of IVTH NERVE PARALYSIS (IVth nerve paralysis), LACUNAR STROKE (Lacunar stroke), LACUNAR INFARCTION (Lacunar infarction), COGNITIVE DISORDER (Cognitive disorder) and DIPLOPIA (Diplopia) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced IVTH NERVE PARALYSIS (IVth nerve paralysis) (seriousness criterion medically significant), LACUNAR STROKE (Lacunar stroke) (seriousness criterion medically significant), LACUNAR INFARCTION (Lacunar infarction) (seriousness criterion medically significant), COGNITIVE DISORDER (Cognitive disorder) (seriousness criterion medically significant) and DIPLOPIA (Diplopia) (seriousness criterion medically significant). At the time of the report, IVTH NERVE PARALYSIS (IVth nerve paralysis), LACUNAR STROKE (Lacunar stroke), LACUNAR INFARCTION (Lacunar infarction), COGNITIVE DISORDER (Cognitive disorder) and DIPLOPIA (Diplopia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) ABNORMAL (26-FEB).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter reported that patient has history of cerebral microvascular disease and also the reporter mentioned statements like binocular diplopia that is secondary to diabetes.  No concomitant medications were reported.  This case concerns an 81-year-old male with serious unexpected events of IVth nerve paralysis, diplopia, lacunar stroke, lacunar infarction, and cognitive disorder. Event latency 11 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an 81-year-old male with serious unexpected events of IVth nerve paralysis, diplopia, lacunar stroke, lacunar infarction, and cognitive disorder. Event latency 11 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging abnormal, Neurological examination normal
Clinical narrative: IVth nerve paralysis; Lacunar stroke; Lacunar infarction; Cognitive disorder; Diplopia; This case was received via VAERS (Reference number: 1350072) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of IVTH NERVE PARALYSIS (IVth nerve paralysis), LACUNAR STROKE (Lacunar stroke), LACUNAR INFARCTION (Lacunar infarction), COGNITIVE DISORDER (Cognitive disorder) and DIPLOPIA (Diplopia) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced IVTH NERVE PARALYSIS (IVth nerve paralysis) (seriousness criterion medically significant), LACUNAR STROKE (Lacunar stroke) (seriousness criterion medically significant), LACUNAR INFARCTION (Lacunar infarction) (seriousness criterion medically significant), COGNITIVE DISORDER (Cognitive disorder) (seriousness criterion medically significant) and DIPLOPIA (Diplopia) (seriousness criterion medically significant). At the time of the report, IVTH NERVE PARALYSIS (IVth nerve paralysis), LACUNAR STROKE (Lacunar stroke), LACUNAR INFARCTION (Lacunar infarction), COGNITIVE DISORDER (Cognitive disorder) and DIPLOPIA (Diplopia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) ABNORMAL (26-FEB).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter reported that patient has history of cerebral microvascular disease and also the reporter mentioned statements like binocular diplopia that is secondary to diabetes.  No concomitant medications were reported.  This case concerns an 81-year-old male with serious unexpected events of IVth nerve paralysis, diplopia, lacunar stroke, lacunar infarction, and cognitive disorder. Event latency 11 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an 81-year-old male with serious unexpected events of IVth nerve paralysis, diplopia, lacunar stroke, lacunar infarction, and cognitive disorder. Event latency 11 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: IVth nerve paralysis; Lacunar stroke; Lacunar infarction; Cognitive disorder; Diplopia; This case was received via VAERS (Reference number: 1350072) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of IVTH NERVE PARALYSIS (IVth nerve paralysis), LACUNAR STROKE (Lacunar stroke), LACUNAR INFARCTION (Lacunar infarction), COGNITIVE DISORDER (Cognitive disorder) and DIPLOPIA (Diplopia) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced IVTH NERVE PARALYSIS (IVth nerve paralysis) (seriousness criterion medically significant), LACUNAR STROKE (Lacunar stroke) (seriousness criterion medically significant), LACUNAR INFARCTION (Lacunar infarction) (seriousness criterion medically significant), COGNITIVE DISORDER (Cognitive disorder) (seriousness criterion medically significant) and DIPLOPIA (Diplopia) (seriousness criterion medically significant). At the time of the report, IVTH NERVE PARALYSIS (IVth nerve paralysis), LACUNAR STROKE (Lacunar stroke), LACUNAR INFARCTION (Lacunar infarction), COGNITIVE DISORDER (Cognitive disorder) and DIPLOPIA (Diplopia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) ABNORMAL (26-FEB).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter reported that patient has history of cerebral microvascular disease and also the reporter mentioned statements like binocular diplopia that is secondary to diabetes.  No concomitant medications were reported.  This case concerns an 81-year-old male with serious unexpected events of IVth nerve paralysis, diplopia, lacunar stroke, lacunar infarction, and cognitive disorder. Event latency 11 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an 81-year-old male with serious unexpected events of IVth nerve paralysis, diplopia, lacunar stroke, lacunar infarction, and cognitive disorder. Event latency 11 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Bundle branch block right, Cardiac ablation, Cardiac monitoring, Cold sweat
Clinical narrative: super dizzy; almost passed out; blood pressure was erratic; my premature ventricular contractions increased tremendously; my premature ventricular contractions increased tremendously; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient reported that she second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER2613) via an unspecified route of administration in left arm on 16Mar2021 at 15:45 (at the age of 67-year-old) for COVID-19 immunisation. Relevant medical history included celiac disease, premature ventricular contractions and allergy to shellfish, penicillin and atropine. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6203) in left arm at on 22Feb2021 at 17:00 (at the age of 67-year-old). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. It was also reported that nasal swab was negative on 12Apr2021 and 23May2021. Concomitant medications included metropolol, dicyclomine, pantoprazole. At 36 hours after receiving the second shot, on 18Mar2021, the patient woke up at 3:30 AM super dizzy. That continued but was pretty much gone by morning. When she got up, she almost passed out. Over the next days, blood pressure was erratic and her premature ventricular contractions increased tremendously.  She went to the ER on 12Apr2021 (as reported) and every third heartbeat was a PVC. On 25May2021, she had a heart catheter ablation because she was having PVC's every 2 seconds and sometimes more per her cardiologist. Prior to the second shot, metropolol had been controlling the PVC's very well. All events required Emergency Room and Physician Office visit. The events were serious due to hospitalization and as life-threatening. The patient was recovering from the events.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: super dizzy; almost passed out; blood pressure was erratic; my premature ventricular contractions increased tremendously; my premature ventricular contractions increased tremendously; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient reported that she second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER2613) via an unspecified route of administration in left arm on 16Mar2021 at 15:45 (at the age of 67-year-old) for COVID-19 immunisation. Relevant medical history included celiac disease, premature ventricular contractions and allergy to shellfish, penicillin and atropine. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6203) in left arm at on 22Feb2021 at 17:00 (at the age of 67-year-old). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. It was also reported that nasal swab was negative on 12Apr2021 and 23May2021. Concomitant medications included metropolol, dicyclomine, pantoprazole. At 36 hours after receiving the second shot, on 18Mar2021, the patient woke up at 3:30 AM super dizzy. That continued but was pretty much gone by morning. When she got up, she almost passed out. Over the next days, blood pressure was erratic and her premature ventricular contractions increased tremendously.  She went to the ER on 12Apr2021 (as reported) and every third heartbeat was a PVC. On 25May2021, she had a heart catheter ablation because she was having PVC's every 2 seconds and sometimes more per her cardiologist. Prior to the second shot, metropolol had been controlling the PVC's very well. All events required Emergency Room and Physician Office visit. The events were serious due to hospitalization and as life-threatening. The patient was recovering from the events.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Left atrial enlargement, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart, Muscular weakness
Clinical narrative: super dizzy; almost passed out; blood pressure was erratic; my premature ventricular contractions increased tremendously; my premature ventricular contractions increased tremendously; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient reported that she second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER2613) via an unspecified route of administration in left arm on 16Mar2021 at 15:45 (at the age of 67-year-old) for COVID-19 immunisation. Relevant medical history included celiac disease, premature ventricular contractions and allergy to shellfish, penicillin and atropine. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6203) in left arm at on 22Feb2021 at 17:00 (at the age of 67-year-old). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. It was also reported that nasal swab was negative on 12Apr2021 and 23May2021. Concomitant medications included metropolol, dicyclomine, pantoprazole. At 36 hours after receiving the second shot, on 18Mar2021, the patient woke up at 3:30 AM super dizzy. That continued but was pretty much gone by morning. When she got up, she almost passed out. Over the next days, blood pressure was erratic and her premature ventricular contractions increased tremendously.  She went to the ER on 12Apr2021 (as reported) and every third heartbeat was a PVC. On 25May2021, she had a heart catheter ablation because she was having PVC's every 2 seconds and sometimes more per her cardiologist. Prior to the second shot, metropolol had been controlling the PVC's very well. All events required Emergency Room and Physician Office visit. The events were serious due to hospitalization and as life-threatening. The patient was recovering from the events.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Myocardial infarction, Pain, Right atrial dilatation, Sleep disorder
Clinical narrative: super dizzy; almost passed out; blood pressure was erratic; my premature ventricular contractions increased tremendously; my premature ventricular contractions increased tremendously; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient reported that she second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER2613) via an unspecified route of administration in left arm on 16Mar2021 at 15:45 (at the age of 67-year-old) for COVID-19 immunisation. Relevant medical history included celiac disease, premature ventricular contractions and allergy to shellfish, penicillin and atropine. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6203) in left arm at on 22Feb2021 at 17:00 (at the age of 67-year-old). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. It was also reported that nasal swab was negative on 12Apr2021 and 23May2021. Concomitant medications included metropolol, dicyclomine, pantoprazole. At 36 hours after receiving the second shot, on 18Mar2021, the patient woke up at 3:30 AM super dizzy. That continued but was pretty much gone by morning. When she got up, she almost passed out. Over the next days, blood pressure was erratic and her premature ventricular contractions increased tremendously.  She went to the ER on 12Apr2021 (as reported) and every third heartbeat was a PVC. On 25May2021, she had a heart catheter ablation because she was having PVC's every 2 seconds and sometimes more per her cardiologist. Prior to the second shot, metropolol had been controlling the PVC's very well. All events required Emergency Room and Physician Office visit. The events were serious due to hospitalization and as life-threatening. The patient was recovering from the events.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication, Ventricular extrasystoles
Clinical narrative: super dizzy; almost passed out; blood pressure was erratic; my premature ventricular contractions increased tremendously; my premature ventricular contractions increased tremendously; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient reported that she second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER2613) via an unspecified route of administration in left arm on 16Mar2021 at 15:45 (at the age of 67-year-old) for COVID-19 immunisation. Relevant medical history included celiac disease, premature ventricular contractions and allergy to shellfish, penicillin and atropine. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6203) in left arm at on 22Feb2021 at 17:00 (at the age of 67-year-old). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. It was also reported that nasal swab was negative on 12Apr2021 and 23May2021. Concomitant medications included metropolol, dicyclomine, pantoprazole. At 36 hours after receiving the second shot, on 18Mar2021, the patient woke up at 3:30 AM super dizzy. That continued but was pretty much gone by morning. When she got up, she almost passed out. Over the next days, blood pressure was erratic and her premature ventricular contractions increased tremendously.  She went to the ER on 12Apr2021 (as reported) and every third heartbeat was a PVC. On 25May2021, she had a heart catheter ablation because she was having PVC's every 2 seconds and sometimes more per her cardiologist. Prior to the second shot, metropolol had been controlling the PVC's very well. All events required Emergency Room and Physician Office visit. The events were serious due to hospitalization and as life-threatening. The patient was recovering from the events.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure fluctuation, Condition aggravated, Dizziness, Presyncope, SARS-CoV-2 test negative
Clinical narrative: super dizzy; almost passed out; blood pressure was erratic; my premature ventricular contractions increased tremendously; my premature ventricular contractions increased tremendously; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient reported that she second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER2613) via an unspecified route of administration in left arm on 16Mar2021 at 15:45 (at the age of 67-year-old) for COVID-19 immunisation. Relevant medical history included celiac disease, premature ventricular contractions and allergy to shellfish, penicillin and atropine. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6203) in left arm at on 22Feb2021 at 17:00 (at the age of 67-year-old). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. It was also reported that nasal swab was negative on 12Apr2021 and 23May2021. Concomitant medications included metropolol, dicyclomine, pantoprazole. At 36 hours after receiving the second shot, on 18Mar2021, the patient woke up at 3:30 AM super dizzy. That continued but was pretty much gone by morning. When she got up, she almost passed out. Over the next days, blood pressure was erratic and her premature ventricular contractions increased tremendously.  She went to the ER on 12Apr2021 (as reported) and every third heartbeat was a PVC. On 25May2021, she had a heart catheter ablation because she was having PVC's every 2 seconds and sometimes more per her cardiologist. Prior to the second shot, metropolol had been controlling the PVC's very well. All events required Emergency Room and Physician Office visit. The events were serious due to hospitalization and as life-threatening. The patient was recovering from the events.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: super dizzy; almost passed out; blood pressure was erratic; my premature ventricular contractions increased tremendously; my premature ventricular contractions increased tremendously; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient reported that she second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER2613) via an unspecified route of administration in left arm on 16Mar2021 at 15:45 (at the age of 67-year-old) for COVID-19 immunisation. Relevant medical history included celiac disease, premature ventricular contractions and allergy to shellfish, penicillin and atropine. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6203) in left arm at on 22Feb2021 at 17:00 (at the age of 67-year-old). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. It was also reported that nasal swab was negative on 12Apr2021 and 23May2021. Concomitant medications included metropolol, dicyclomine, pantoprazole. At 36 hours after receiving the second shot, on 18Mar2021, the patient woke up at 3:30 AM super dizzy. That continued but was pretty much gone by morning. When she got up, she almost passed out. Over the next days, blood pressure was erratic and her premature ventricular contractions increased tremendously.  She went to the ER on 12Apr2021 (as reported) and every third heartbeat was a PVC. On 25May2021, she had a heart catheter ablation because she was having PVC's every 2 seconds and sometimes more per her cardiologist. Prior to the second shot, metropolol had been controlling the PVC's very well. All events required Emergency Room and Physician Office visit. The events were serious due to hospitalization and as life-threatening. The patient was recovering from the events.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Pulmonary embolism
Clinical narrative: Pulmonary Embolism; This is a spontaneous report from a contactable consumer. A 72-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 11Feb2021 12:00(Age at vaccination 72 years) as 2nd dose, single for covid-19 immunisation.  Medical history included, psoriatic Arthritis, RA(Rheumatoid arthritis) .The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 21Jan2021 02:00 as 1st dose, single for covid-19 immunisation. On 13Feb2021 12:00 the patient experienced pulmonary embolism leads to hospitalization, life threatening . The patient was hospitalized for pulmonary embolism for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 13Feb2021. Patient received treatment of clot buster blood thinners. The outcome of event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.