chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Nasopharyngitis, Pain in extremity
Clinical narrative: infected with Covid-19; cough; felt cold; got weak; Arm hurt; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (infected with Covid-19) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 04-Mar-2021, the patient experienced COUGH (cough), NASOPHARYNGITIS (felt cold) and ASTHENIA (got weak). On 13-Mar-2021, the patient experienced COVID-19 (infected with Covid-19) (seriousness criterion hospitalization). The patient was hospitalized from 13-Mar-2021 to 27-Mar-2021 due to COVID-19. At the time of the report, COVID-19 (infected with Covid-19), COUGH (cough), PAIN IN EXTREMITY (Arm hurt), NASOPHARYNGITIS (felt cold) and ASTHENIA (got weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. Further information has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Psychotic disorder
Clinical narrative: "very severe psychotic thoughts"; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOTIC DISORDER ("very severe psychotic thoughts") in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PSYCHOTIC DISORDER ("very severe psychotic thoughts") (seriousness criterion medically significant). On 20-Mar-2021, PSYCHOTIC DISORDER ("very severe psychotic thoughts") had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included High blood pressure medication and type 2 diabetes medication.  No treatment information was 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Intentional dose omission
Clinical narrative: tired; headache; back hurt; It has been more than 36 days days from 12Jan2021; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and HEADACHE (headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L2DA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Relevant medical history not reported).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired), HEADACHE (headache), BACK PAIN (back hurt) and INTENTIONAL PRODUCT USE ISSUE (It has been more than 36 days days from 12Jan2021). At the time of the report, FATIGUE (tired), HEADACHE (headache), BACK PAIN (back hurt) and INTENTIONAL DOSE OMISSION (It has been more than 36 days days from 12Jan2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.  Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dysarthria, Dyspnoea, Swelling face
Clinical narrative: stroke; face is swollen; shortness of breath; Difficulty in speaking; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), SWELLING FACE (face is swollen), DYSPNOEA (shortness of breath) and DYSARTHRIA (Difficulty in speaking). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), SWELLING FACE (face is swollen), DYSPNOEA (shortness of breath) and DYSARTHRIA (Difficulty in speaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  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.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Fall, Rhabdomyolysis
Clinical narrative: Rhabdomyolisis; Fall; This spontaneous case was reported by a pharmacist and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolisis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolisis) (seriousness criterion medically significant) and FALL (Fall). At the time of the report, RHABDOMYOLYSIS (Rhabdomyolisis) and FALL (Fall) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood creatine phosphokinase: high High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pneumonia viral, SARS-CoV-2 test positive
Clinical narrative: viral pneumonia; Tested positive for Covid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA VIRAL (viral pneumonia) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PNEUMONIA VIRAL (viral pneumonia) (seriousness criterion medically significant) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid). At the time of the report, PNEUMONIA VIRAL (viral pneumonia) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. Seen in ED for testing and treatment (unknown).  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.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing on the ears; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing on the ears) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing on the ears) (seriousness criterion medically significant). At the time of the report, TINNITUS (ringing on the ears) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information was provided.  This case concerns an adult of unknown age and gender with a serious unexpected event of tinnitus. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. 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 adult of unknown age and gender with a serious unexpected event of tinnitus. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Illness, Immobile, Nausea, Pain in extremity
Clinical narrative: could not get out of bed; very sick; could not eat; severe pain on her left side especially in her leg; nausea; This spontaneous case was reported by a consumer and describes the occurrence of IMMOBILE (could not get out of bed) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinson's disease (Parkinson).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced IMMOBILE (could not get out of bed) (seriousness criterion medically significant), ILLNESS (very sick), FEEDING DISORDER (could not eat), PAIN IN EXTREMITY (severe pain on her left side especially in her leg) and NAUSEA (nausea). On 04-Apr-2021, IMMOBILE (could not get out of bed), ILLNESS (very sick), FEEDING DISORDER (could not eat), PAIN IN EXTREMITY (severe pain on her left side especially in her leg) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.  Company comment: This case concerns an 83-year-old female with Parkinson's disease, had a serious unexpected event of immobile, and non serious unexpected illness, feeding disorder, pain in extremity, and expected nausea. Event onset the same day as first dose mRNA-1273. Event resolved. 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 83-year-old female with Parkinson's disease, had a serious unexpected event of immobile, and nonserious unexpected illness, feeding disorder, pain in extremity, and expected nausea. Event onset the same day as first dose mRNA-1273. Event resolved. 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Herpes zoster, Insomnia, Rash
Clinical narrative: Diagnosed with shingles; the rash is on my torso and in the back; I couldn't sleep at night; The pain was excruciating; Discomfort pains in center of chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Discomfort pains in center of chest), CHEST PAIN (The pain was excruciating) and HERPES ZOSTER (Diagnosed with shingles) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (medical history was not reported.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced CHEST PAIN (Discomfort pains in center of chest) (seriousness criterion medically significant). On 27-Mar-2021, the patient experienced CHEST PAIN (The pain was excruciating) (seriousness criterion medically significant) and INSOMNIA (I couldn't sleep at night). On 28-Mar-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles) (seriousness criterion medically significant) and RASH (the rash is on my torso and in the back). At the time of the report, CHEST PAIN (Discomfort pains in center of chest), CHEST PAIN (The pain was excruciating), HERPES ZOSTER (Diagnosed with shingles), INSOMNIA (I couldn't sleep at night) and RASH (the rash is on my torso and in the back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included  Famciclovir for 7 days initially and Acyclovir ointment for the Shingles rash and Celebrex for the pain.  This case concerns a 70-year-old female with a serious unexpected event of chest pain and herpes zoster, and nonserious unexpected insomnia and rash. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. 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 a 70-year-old female with a serious unexpected event of chest pain and herpes zoster, and nonserious unexpected insomnia and rash. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Peripheral swelling, Pneumonia, Somnolence
Clinical narrative: Pneumonia; Slept almost all day; Left arm swollen; Hot above the site of injection; Entire body really aching; Redness on the site of injection; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leukemia in 2011. Concurrent medical conditions included Hearing impaired. Concomitant products included LATANOPROST for Glaucoma, DORZOLAMIDE and VITAMINS NOS from an unknown date to 03-Apr-2021 for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness) outcome was unknown.            Treatment for the event included paracetamol. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Pneumonia; Slept almost all day; Left arm swollen; Hot above the site of injection; Entire body really aching; Redness on the site of injection; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leukemia in 2011. Concurrent medical conditions included Hearing impaired. Concomitant products included LATANOPROST for Glaucoma, DORZOLAMIDE and VITAMINS NOS from an unknown date to 03-Apr-2021 for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness) outcome was unknown.            Treatment for the event included paracetamol. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: It was just a few small red blotches; A rash started on my front torso; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (It was just a few small red blotches) and RASH (A rash started on my front torso) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced RASH MACULAR (It was just a few small red blotches) (seriousness criterion medically significant) and RASH (A rash started on my front torso) (seriousness criterion medically significant). At the time of the report, RASH MACULAR (It was just a few small red blotches) and RASH (A rash started on my front torso) outcome was unknown.      Patient received treatment cortisone cream.   No concomitant medication was reported.  Company Comment  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.   This case was linked to MOD-2021-068590 (E2B Linked Report).; Sender's Comments:  MOD-2021-068590:2nd dose of vaccine
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache
Clinical narrative: shortness of breath; chest pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included BUPROPION HYDROBROMIDE (APLENZIN), LAMOTRIGINE, ALPRAZOLAM (XANAX), OLMESARTAN MEDOXOMIL (BENICAR), LURASIDONE HYDROCHLORIDE (LATUDA), BENZATROPINE MESILATE (COGENTIN), ESTRADIOL, VITAMIN D2 and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion medically significant), CHEST PAIN (chest pain) and HEADACHE (headache). At the time of the report, DYSPNOEA (shortness of breath), CHEST PAIN (chest pain) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for events include rescue inhaler, nebulizer, ibuprofen 800 mg.  The events of Chest pain and Headache are NON-serious and NOT Medically Significant.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: allergic reaction to the vaccine; Chills; Shortness of Breath; Light Headedness; Numbness of the cheek; Pressure on the chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of Breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath) (seriousness criterion medically significant), DIZZINESS (Light Headedness), HYPOAESTHESIA (Numbness of the cheek) and CHEST DISCOMFORT (Pressure on the chest). On 04-Apr-2021, the patient experienced VACCINATION COMPLICATION (allergic reaction to the vaccine) and CHILLS (Chills). On 26-Mar-2021, DIZZINESS (Light Headedness) had resolved. At the time of the report, DYSPNOEA (Shortness of Breath), HYPOAESTHESIA (Numbness of the cheek), CHEST DISCOMFORT (Pressure on the chest), VACCINATION COMPLICATION (allergic reaction to the vaccine) and CHILLS (Chills) outcome was unknown.        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.   This case concerns a 69-year-old female with a serious unexpected event of dyspnea, chest discomfort, dizziness, hypoesthesia, vaccination complication and expected chills. Event onset the same day as 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 a 69-year-old female with a serious unexpected event of dyspnea, chest discomfort, dizziness, hypoesthesia, vaccination complication and expected chills. Event onset the same day as 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: allergic reaction to the vaccine; Chills; Shortness of Breath; Light Headedness; Numbness of the cheek; Pressure on the chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of Breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath) (seriousness criterion medically significant), DIZZINESS (Light Headedness), HYPOAESTHESIA (Numbness of the cheek) and CHEST DISCOMFORT (Pressure on the chest). On 04-Apr-2021, the patient experienced VACCINATION COMPLICATION (allergic reaction to the vaccine) and CHILLS (Chills). On 26-Mar-2021, DIZZINESS (Light Headedness) had resolved. At the time of the report, DYSPNOEA (Shortness of Breath), HYPOAESTHESIA (Numbness of the cheek), CHEST DISCOMFORT (Pressure on the chest), VACCINATION COMPLICATION (allergic reaction to the vaccine) and CHILLS (Chills) outcome was unknown.        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.   This case concerns a 69-year-old female with a serious unexpected event of dyspnea, chest discomfort, dizziness, hypoesthesia, vaccination complication and expected chills. Event onset the same day as 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 a 69-year-old female with a serious unexpected event of dyspnea, chest discomfort, dizziness, hypoesthesia, vaccination complication and expected chills. Event onset the same day as 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Product dose omission issue
Clinical narrative: Shortness of breath and whizzing; Not receiving the 2nd dose; Tiredness; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath and whizzing) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included No adverse event.  On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath and whizzing) (seriousness criterion hospitalization). On 07-Apr-2021, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Tiredness ). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not receiving the 2nd dose). The patient was hospitalized from 28-Mar-2021 to 06-Apr-2021 due to DYSPNOEA. At the time of the report, DYSPNOEA (Shortness of breath and whizzing), DIZZINESS (Dizziness) and FATIGUE (Tiredness ) had not resolved and PRODUCT DOSE OMISSION ISSUE (Not receiving the 2nd dose) had resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Patient received a lot of medications at hospital  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Food refusal
Clinical narrative: Death Narrative:  80 yr old metastatic lung cancer, had stopped eating, still wanted vaccine, Died on hospice service. no vaccine complications reported.
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death Narrative:  Patient was 96 yr old, prostate cancer, peg tube placed, Died on Hospice service, No vaccine complication reported.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Death, Dyspnoea, Fatigue, Oedema peripheral
Clinical narrative: Death Narrative: 4/12 patient had fatigue/dyspnea -Per NP visit/note: -" reviewed with office/clinic team MD on phone, clinically does not appear to have fluid overload, has chronic LE edema which is no worse than usual, could be pneumonia possible aspiration related to dyaphagia. patient does not want to go to hospital for evaluation and treatment. Spoke with patient's daughter, confirms DNR and LST wishes, no hospitalization, no cpr/ventilation/feeding tubes. She is agreeable to treating with low dose diuretic and antibiotic in effort to help symptoms. She is agreeable to hospice consult. -cipro 250 mg po bid x 7 days, furosemide 10 mg qday and kcl 10 meq x7 days called into pharmacy. caregiver to pick up today. reviewed s/e and precautions with meds in addition to indications - caregiver encouraged to keep patient upright in chair or bed for easier breathing. "
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: EXPIRED Narrative:  86 y/o male who received first dose of COVID-19 vaccine (Moderna) 1/22/21 and never returned for second dose. COVID-19 clinic alerted the pharmacist that patient expired prior to receiving second dose. Unknown reason.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Death, Diarrhoea, Gastrointestinal haemorrhage, Mental status changes
Clinical narrative: Death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 76 and presented to the ER on 2/20/21 with altered mental status, weakness, and persistent diarrhea after just being discharged previous week for bacteremia. Hospital progression included a GI bleed requiring blood transfusions, esophageal varices, and unrecoverable mental status. Care was transitioned to hospice where he passed on 2/28/21. Comorbidities include cirrhosis, CKD, DM, pancytopenia, frequent paracentesis for ascites.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Transfusion, Varices oesophageal
Clinical narrative: Death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 76 and presented to the ER on 2/20/21 with altered mental status, weakness, and persistent diarrhea after just being discharged previous week for bacteremia. Hospital progression included a GI bleed requiring blood transfusions, esophageal varices, and unrecoverable mental status. Care was transitioned to hospice where he passed on 2/28/21. Comorbidities include cirrhosis, CKD, DM, pancytopenia, frequent paracentesis for ascites.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Diarrhoea, Encephalopathy, Fall, Haematochezia
Clinical narrative: Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient presented to the ER on 3/8/21 after being sick the prior 2 weeks with loose, bloody/tarry stools, frequent falls, and hypotension. Hospital course progressed to worsening encephalopathy secondary to decompensated alcoholic cirrhosis. Developed pneumonia that did not improve with antibiotics and progressed to palliative care with him passing away on 3/24/21. Comorbidities include COPD, alcoholism, Takotsubo cardiomyopathy, HTN, cirrhosis, HLD, former smoker.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Melaena, Pneumonia
Clinical narrative: Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient presented to the ER on 3/8/21 after being sick the prior 2 weeks with loose, bloody/tarry stools, frequent falls, and hypotension. Hospital course progressed to worsening encephalopathy secondary to decompensated alcoholic cirrhosis. Developed pneumonia that did not improve with antibiotics and progressed to palliative care with him passing away on 3/24/21. Comorbidities include COPD, alcoholism, Takotsubo cardiomyopathy, HTN, cirrhosis, HLD, former smoker.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 94 and receiving hospice care for end life care in the months leading up to his passing on 3/9/21. In addition to his advanced age, the patient had chronic afib on anticoagulation, hypothyroidism, HTN, HLD, COPD, depression, and increasing cognitive and memory issues towards the end of his life.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 86 but did not have a lot of history of receiving medical care in the system. There is note mentioned his death in the chart. His possible contributing comorbidities are advanced age, HTN, HLD, DM, mitral valve insufficiency.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH,allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. No notes detailing the circumstances the death of the patient. Patient had issues controlling his blood pressure in the prior 6  months with an average BP of 150/68 and systolic blood pressure readings >200 at times, Other comorbidities include anemia, DM2, Afib on pradaxa, cardiac pacemaker, and HLD.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, COVID-19 pneumonia, Death, Hyperhidrosis
Clinical narrative: Death Narrative:  The patient did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. Patient transported to ER on 1/14/21 after receiving first COVID-19 vaccine earlier that day. He was reported to have a reaction to the vaccine including diaphoresis, new onset afib, and hypotension(vasovagal reaction). He was discharged the next day with no signs of afib. Patient was later hospitalized around 1/28/21 for COVID pneumonia. He later passed away on 2/5/21 due to hypoxic respiratory failure secondary to COVID-19. Comorbidities include advanced age, obesity, HLD, atherosclerosis, DM2, HTN.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Presyncope, Respiratory failure
Clinical narrative: Death Narrative:  The patient did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. Patient transported to ER on 1/14/21 after receiving first COVID-19 vaccine earlier that day. He was reported to have a reaction to the vaccine including diaphoresis, new onset afib, and hypotension(vasovagal reaction). He was discharged the next day with no signs of afib. Patient was later hospitalized around 1/28/21 for COVID pneumonia. He later passed away on 2/5/21 due to hypoxic respiratory failure secondary to COVID-19. Comorbidities include advanced age, obesity, HLD, atherosclerosis, DM2, HTN.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 90 but not receiving frequent care from facility and circumstances regarding his cause of death not certain. His comorbidities include advanced age, afib, cardiac pacemaker, HTN, Barrett's esophagus, HTN, and hypothyroidism.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Fall, Prostate cancer metastatic, Subdural haematoma
Clinical narrative: Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 80 and discharged on 2/17/21 with hospice after falling and suffering a subdural hematoma. Patient was likely reaching end of life from metastatic prostate cancer before fall.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Death
Clinical narrative: Death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 81 and brought to the Hospital ER on 3/4/21 w/ a STEMI. He did not recover and later passed away there on 3/10/21. Comorbidities include diabetes, HLD, HTN, cardiac murmur.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Ischaemic skin ulcer
Clinical narrative: Death Narrative:  91 yr old Arterial ulcer on toe, not surgical candidate, patient opted palliative care, hospice enrolled, Died on hospice service. No vaccine complications reported.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Nephrogenic anaemia, Renal failure
Clinical narrative: Death Narrative:  95 yr old Renal failure, renal anemia, Died on Hospice service. No vaccine complications reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Blood pressure measurement, Chest X-ray, Cough, Diarrhoea
Clinical narrative: cough; fluid buildup in lungs; elevation in blood pressure; hoarseness; diarrhea; vomiting; This is a spontaneous report from a contactable physician, based on information received by Pfizer(manufacturer control number: EC-2021-087665), for BNT162B2.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization; and lenvatinib mesilate (LENVIMA), via an unspecified route of administration from Jan2021 (Batch/Lot number was not reported) to an unspecified date, at 20 mg, 1x/day; via an unspecified route of administration from 31Mar2021 (Batch/Lot number was not reported) to an unspecified date, at 10 mg for endometrial cancer. Medical history included endometrial carcinoma, pleural effusion, and thoracentesis; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Keytruda infusions (drug therapy). It was reported that on 06Mar2021, the patient experienced vomiting and diarrhea. Oncologist was notified and advised the patient to stop Lenvima temporarily. The patient was also advised not to receive second COVID vaccine at this time. The patient was recently hospitalized for cough (unknown date of hospitalization or length of hospitalization). CXR (Chest X-ray) determined fluid buildup in lungs and thoracentesis completed. The patient had 650 ml of fluid removed. The patient resumed Lenvima and Keytruda infusions on 31Mar2021. The patient continued to experience hoarseness and elevation in blood pressure (unknown date of onset of symptoms). The patient is scheduled to repeat CT scans on 09Apr2021 and meet with oncologist next week to discuss results. Therapeutic measures were taken as a result of cough and fluid buildup in lungs. The action taken in response to the events for lenvatinib mesilate was temporarily withdrawn on an unspecified date. The outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided, there is no information to suggest a causal relationship between BNT162B2 and the reported events of cough and pleural effusion. This patients underlying malignancy with previous history of pleural effusion is assessed as a contributing factor. Case will be reassessed upon receipt of additional information. 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.