chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Body temperature increased, Diarrhoea
Clinical narrative: tongue and lip tingling; subjective swelling; This is a spontaneous report from a contactable physician reported that a 37-years-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on 27Jan2021 at single dose for covid-19 immunisation. Medical history included anaphylaxis; nightshade vegetable allergy; Food allergy, migraine, Attention deficit hyperactivity disorder, anxiety, former smoker. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), alprazolam (XANAX), escitalopram oxalate (LEXAPRO), ethinylestradiol, norethisterone acetate (JUNEL), amitriptyline (AMITRIPTYLINE). The patient previously took atropine had anaphylaxis and known allergies. On 27Jan2021, patient developed tongue and lip tingling and subjective swelling within 10 minutes after vaccine administration. No angioedema. The patient was received treatment with benadryl, pepcid, IVF and solumedrol. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, was the patient was not diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. The outcome of the events was recovered in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events "tongue and lip tingling and subjective swelling" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Hypertension, Nausea
Clinical narrative: tongue and lip tingling; subjective swelling; This is a spontaneous report from a contactable physician reported that a 37-years-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on 27Jan2021 at single dose for covid-19 immunisation. Medical history included anaphylaxis; nightshade vegetable allergy; Food allergy, migraine, Attention deficit hyperactivity disorder, anxiety, former smoker. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), alprazolam (XANAX), escitalopram oxalate (LEXAPRO), ethinylestradiol, norethisterone acetate (JUNEL), amitriptyline (AMITRIPTYLINE). The patient previously took atropine had anaphylaxis and known allergies. On 27Jan2021, patient developed tongue and lip tingling and subjective swelling within 10 minutes after vaccine administration. No angioedema. The patient was received treatment with benadryl, pepcid, IVF and solumedrol. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, was the patient was not diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. The outcome of the events was recovered in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events "tongue and lip tingling and subjective swelling" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nervousness, Pain, Paraesthesia oral, Pyrexia, Swollen tongue
Clinical narrative: tongue and lip tingling; subjective swelling; This is a spontaneous report from a contactable physician reported that a 37-years-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on 27Jan2021 at single dose for covid-19 immunisation. Medical history included anaphylaxis; nightshade vegetable allergy; Food allergy, migraine, Attention deficit hyperactivity disorder, anxiety, former smoker. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), alprazolam (XANAX), escitalopram oxalate (LEXAPRO), ethinylestradiol, norethisterone acetate (JUNEL), amitriptyline (AMITRIPTYLINE). The patient previously took atropine had anaphylaxis and known allergies. On 27Jan2021, patient developed tongue and lip tingling and subjective swelling within 10 minutes after vaccine administration. No angioedema. The patient was received treatment with benadryl, pepcid, IVF and solumedrol. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, was the patient was not diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. The outcome of the events was recovered in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events "tongue and lip tingling and subjective swelling" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: tongue and lip tingling; subjective swelling; This is a spontaneous report from a contactable physician reported that a 37-years-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on 27Jan2021 at single dose for covid-19 immunisation. Medical history included anaphylaxis; nightshade vegetable allergy; Food allergy, migraine, Attention deficit hyperactivity disorder, anxiety, former smoker. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), alprazolam (XANAX), escitalopram oxalate (LEXAPRO), ethinylestradiol, norethisterone acetate (JUNEL), amitriptyline (AMITRIPTYLINE). The patient previously took atropine had anaphylaxis and known allergies. On 27Jan2021, patient developed tongue and lip tingling and subjective swelling within 10 minutes after vaccine administration. No angioedema. The patient was received treatment with benadryl, pepcid, IVF and solumedrol. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, was the patient was not diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. The outcome of the events was recovered in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events "tongue and lip tingling and subjective swelling" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia oral, Swelling
Clinical narrative: tongue and lip tingling; subjective swelling; This is a spontaneous report from a contactable physician reported that a 37-years-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on 27Jan2021 at single dose for covid-19 immunisation. Medical history included anaphylaxis; nightshade vegetable allergy; Food allergy, migraine, Attention deficit hyperactivity disorder, anxiety, former smoker. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), alprazolam (XANAX), escitalopram oxalate (LEXAPRO), ethinylestradiol, norethisterone acetate (JUNEL), amitriptyline (AMITRIPTYLINE). The patient previously took atropine had anaphylaxis and known allergies. On 27Jan2021, patient developed tongue and lip tingling and subjective swelling within 10 minutes after vaccine administration. No angioedema. The patient was received treatment with benadryl, pepcid, IVF and solumedrol. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, was the patient was not diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. The outcome of the events was recovered in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events "tongue and lip tingling and subjective swelling" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Neck pain, Pain, Tenderness
Clinical narrative: Large painful Lymphadenopathy on L side of neck near clavicle, the size of a lemon; This is a spontaneous report from a  contactable other healthcare professional (the patient).  A non-pregnant 58-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), intramuscular in the left arm, on 17Jan2021 at 08:30 AM (at the age of 58 years) as a single dose for COVID-19 immunization.  Medical history included high cholesterol.  The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included estradiol (ESTROGEN), pravastatin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 12:00 PM, the patient developed large painful lymphadenopathy on the left side of neck near clavicle, the size of a lemon. The event was reported as non-serious. Therapeutic measures were taken as a result of large painful lymphadenopathy on left side of neck near clavicle, the size of a lemon. The clinical outcome of the large painful lymphadenopathy on the left side of neck near clavicle, the size of a lemon was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Large painful Lymphadenopathy on L side of neck near clavicle, the size of a lemon; This is a spontaneous report from a  contactable other healthcare professional (the patient).  A non-pregnant 58-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), intramuscular in the left arm, on 17Jan2021 at 08:30 AM (at the age of 58 years) as a single dose for COVID-19 immunization.  Medical history included high cholesterol.  The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included estradiol (ESTROGEN), pravastatin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 12:00 PM, the patient developed large painful lymphadenopathy on the left side of neck near clavicle, the size of a lemon. The event was reported as non-serious. Therapeutic measures were taken as a result of large painful lymphadenopathy on left side of neck near clavicle, the size of a lemon. The clinical outcome of the large painful lymphadenopathy on the left side of neck near clavicle, the size of a lemon was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Her hand is a purple color; Her skin feels like a BP cuff is on it; entire left arm is swollen and red; entire left arm is swollen and red; Her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982 and Expiration date: 31May2021), via an unspecified route of administration at the left arm on 21Jan2021 at a single dose for covid-19 immunization. The patient's has no medical history. There were no concomitant medications. On 22Jan2021, her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off. It hasn't been seeming to get better. The first time she noticed it was the morning after the vaccine. Her entire arm was swollen. She thought it would dissipate. At times it has kind of gotten better, but then the swelling keeps coming right back. Like right now her arm was uncomfortable in her coat. On an unspecified date, her hand was purple color. Her skin feels like a BP cuff was on it. She has not had treatment for it. The outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Peripheral swelling, Peripheral vascular disorder, Skin discolouration, Skin discomfort
Clinical narrative: Her hand is a purple color; Her skin feels like a BP cuff is on it; entire left arm is swollen and red; entire left arm is swollen and red; Her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982 and Expiration date: 31May2021), via an unspecified route of administration at the left arm on 21Jan2021 at a single dose for covid-19 immunization. The patient's has no medical history. There were no concomitant medications. On 22Jan2021, her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off. It hasn't been seeming to get better. The first time she noticed it was the morning after the vaccine. Her entire arm was swollen. She thought it would dissipate. At times it has kind of gotten better, but then the swelling keeps coming right back. Like right now her arm was uncomfortable in her coat. On an unspecified date, her hand was purple color. Her skin feels like a BP cuff was on it. She has not had treatment for it. The outcome of the events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Cough, Headache, Pain
Clinical narrative: Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe coughing that evening; headache; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EK9231), via an unspecified route of administration on the right arm on 14Jan2021 08:30 at a single dose for COVID-19 immunization at a hospital. Medical history included very chemically sensitive and drug sensitive, interstitial lung disease, and interstitial cystitis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin D, zinc, and an unspecified thyroid medication. On 14Jan2021 13:00, the patient experienced body aches, fatigue, random shooting pains throughout body, upper back pain, abdominal pain, severe coughing that evening, headache, and very sore arm. Treatment included self prescribed paracetamol (TYLENOL). Since the vaccination, the patient has not been tested for COVID-19. The patient has not yet recovered from the events.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe coughing that evening; headache; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EK9231), via an unspecified route of administration on the right arm on 14Jan2021 08:30 at a single dose for COVID-19 immunization at a hospital. Medical history included very chemically sensitive and drug sensitive, interstitial lung disease, and interstitial cystitis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin D, zinc, and an unspecified thyroid medication. On 14Jan2021 13:00, the patient experienced body aches, fatigue, random shooting pains throughout body, upper back pain, abdominal pain, severe coughing that evening, headache, and very sore arm. Treatment included self prescribed paracetamol (TYLENOL). Since the vaccination, the patient has not been tested for COVID-19. The patient has not yet recovered from the events.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Cough, Fatigue, Headache
Clinical narrative: Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe coughing that evening; headache; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EK9231), via an unspecified route of administration on the right arm on 14Jan2021 08:30 at a single dose for COVID-19 immunization at a hospital. Medical history included very chemically sensitive and drug sensitive, interstitial lung disease, and interstitial cystitis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin D, zinc, and an unspecified thyroid medication. On 14Jan2021 13:00, the patient experienced body aches, fatigue, random shooting pains throughout body, upper back pain, abdominal pain, severe coughing that evening, headache, and very sore arm. Treatment included self prescribed paracetamol (TYLENOL). Since the vaccination, the patient has not been tested for COVID-19. The patient has not yet recovered from the events.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe coughing that evening; headache; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EK9231), via an unspecified route of administration on the right arm on 14Jan2021 08:30 at a single dose for COVID-19 immunization at a hospital. Medical history included very chemically sensitive and drug sensitive, interstitial lung disease, and interstitial cystitis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin D, zinc, and an unspecified thyroid medication. On 14Jan2021 13:00, the patient experienced body aches, fatigue, random shooting pains throughout body, upper back pain, abdominal pain, severe coughing that evening, headache, and very sore arm. Treatment included self prescribed paracetamol (TYLENOL). Since the vaccination, the patient has not been tested for COVID-19. The patient has not yet recovered from the events.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nightmare, Pyrexia, Somnolence
Clinical narrative: nightmares; difficulty waking up; This is a spontaneous report from a contactable pharmacist (patient). A 62-year-old non-pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8292), via an unspecified route of administration in the right arm on 27Jan2021 07:15 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) on 09Jan2021 04:45 PM in the left arm for covid-19 immunisation. The patient experienced nightmares and difficulty waking up on 28Jan2021 14:00 with outcome of recovered in 2021. This was very unusual for patient. Events assessed as non-serious. No treatment was received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications that patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nightmare, Somnolence
Clinical narrative: nightmares; difficulty waking up; This is a spontaneous report from a contactable pharmacist (patient). A 62-year-old non-pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8292), via an unspecified route of administration in the right arm on 27Jan2021 07:15 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) on 09Jan2021 04:45 PM in the left arm for covid-19 immunisation. The patient experienced nightmares and difficulty waking up on 28Jan2021 14:00 with outcome of recovered in 2021. This was very unusual for patient. Events assessed as non-serious. No treatment was received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications that patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Sinus congestion
Clinical narrative: Patient admitted for fatigue, dry throat, generalized weakness, dyspnea on exertion. Durion hospitalization was identified to have an acute ischemic CVA -- unclear time of symptom onset, possibly evening of 2/9 or morning of 2/10. Time course suspicious for possible COVID vaccine adverse event. He received his first Moderna COVID vaccine on 2/2/21 per WIR.   Per PCP note on 2/9/21:   Patient is here today accompanied by his wife with concerns for fatigue, headaches, head pressure and tremors. Received vaccine last Tuesday. Around 10 PM that evening he developed pressured in the head.  On Wednesday morning, he states he got out of bed and was in a cold sweat - he states he pajamas were soaked in sweat and he felt chilled. He experienced brief numbness of the left arm down to his fingers.  On Thursday, he felt fine - he went out to snow blow.  Friday he developed headaches and head pressure. At night, he felt his breathing was labored as he was "gasping for air."  On Saturday and Sunday, he sat and laid around all day.  On Monday, he wakes up at 125 AM and his blood pressure was 165/104 and it remained elevated for 3 separate readings.    Patient was then admitted on 2/10/21 with weakness and confusion, then on 2/11 MD noted ?word finding difficulty, slurred speech, possible subtle right upper lip droop, and possibly some mild right hemineglect? with MRI showing likely embolic source of infarcts and cerebral MRA with possible acute thrombus. His symptoms the day after the vaccine seem a bit suspicious for TIA. Per Drug Policy Manager call to Moderna, no current reports of TIA/stroke secondary to COVID vaccine, so time course may be incidental. Patient had echocardiogram without right to left shunt or clot identified, no known history of atrial fibrillation. Was monitored on telemetry for the duration of his hospitalization without any noted arrhythmias, discharged on e patch for 14-day outpatient monitoring.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram abnormal, Asthenia, Blood pressure increased, Cerebral ischaemia, Chills
Clinical narrative: Patient admitted for fatigue, dry throat, generalized weakness, dyspnea on exertion. Durion hospitalization was identified to have an acute ischemic CVA -- unclear time of symptom onset, possibly evening of 2/9 or morning of 2/10. Time course suspicious for possible COVID vaccine adverse event. He received his first Moderna COVID vaccine on 2/2/21 per WIR.   Per PCP note on 2/9/21:   Patient is here today accompanied by his wife with concerns for fatigue, headaches, head pressure and tremors. Received vaccine last Tuesday. Around 10 PM that evening he developed pressured in the head.  On Wednesday morning, he states he got out of bed and was in a cold sweat - he states he pajamas were soaked in sweat and he felt chilled. He experienced brief numbness of the left arm down to his fingers.  On Thursday, he felt fine - he went out to snow blow.  Friday he developed headaches and head pressure. At night, he felt his breathing was labored as he was "gasping for air."  On Saturday and Sunday, he sat and laid around all day.  On Monday, he wakes up at 125 AM and his blood pressure was 165/104 and it remained elevated for 3 separate readings.    Patient was then admitted on 2/10/21 with weakness and confusion, then on 2/11 MD noted ?word finding difficulty, slurred speech, possible subtle right upper lip droop, and possibly some mild right hemineglect? with MRI showing likely embolic source of infarcts and cerebral MRA with possible acute thrombus. His symptoms the day after the vaccine seem a bit suspicious for TIA. Per Drug Policy Manager call to Moderna, no current reports of TIA/stroke secondary to COVID vaccine, so time course may be incidental. Patient had echocardiogram without right to left shunt or clot identified, no known history of atrial fibrillation. Was monitored on telemetry for the duration of his hospitalization without any noted arrhythmias, discharged on e patch for 14-day outpatient monitoring.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Confusional state, Dry throat, Dysarthria, Dyspnoea
Clinical narrative: Patient admitted for fatigue, dry throat, generalized weakness, dyspnea on exertion. Durion hospitalization was identified to have an acute ischemic CVA -- unclear time of symptom onset, possibly evening of 2/9 or morning of 2/10. Time course suspicious for possible COVID vaccine adverse event. He received his first Moderna COVID vaccine on 2/2/21 per WIR.   Per PCP note on 2/9/21:   Patient is here today accompanied by his wife with concerns for fatigue, headaches, head pressure and tremors. Received vaccine last Tuesday. Around 10 PM that evening he developed pressured in the head.  On Wednesday morning, he states he got out of bed and was in a cold sweat - he states he pajamas were soaked in sweat and he felt chilled. He experienced brief numbness of the left arm down to his fingers.  On Thursday, he felt fine - he went out to snow blow.  Friday he developed headaches and head pressure. At night, he felt his breathing was labored as he was "gasping for air."  On Saturday and Sunday, he sat and laid around all day.  On Monday, he wakes up at 125 AM and his blood pressure was 165/104 and it remained elevated for 3 separate readings.    Patient was then admitted on 2/10/21 with weakness and confusion, then on 2/11 MD noted ?word finding difficulty, slurred speech, possible subtle right upper lip droop, and possibly some mild right hemineglect? with MRI showing likely embolic source of infarcts and cerebral MRA with possible acute thrombus. His symptoms the day after the vaccine seem a bit suspicious for TIA. Per Drug Policy Manager call to Moderna, no current reports of TIA/stroke secondary to COVID vaccine, so time course may be incidental. Patient had echocardiogram without right to left shunt or clot identified, no known history of atrial fibrillation. Was monitored on telemetry for the duration of his hospitalization without any noted arrhythmias, discharged on e patch for 14-day outpatient monitoring.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea exertional, Echocardiogram, Embolic cerebral infarction, Fatigue, Head discomfort
Clinical narrative: Patient admitted for fatigue, dry throat, generalized weakness, dyspnea on exertion. Durion hospitalization was identified to have an acute ischemic CVA -- unclear time of symptom onset, possibly evening of 2/9 or morning of 2/10. Time course suspicious for possible COVID vaccine adverse event. He received his first Moderna COVID vaccine on 2/2/21 per WIR.   Per PCP note on 2/9/21:   Patient is here today accompanied by his wife with concerns for fatigue, headaches, head pressure and tremors. Received vaccine last Tuesday. Around 10 PM that evening he developed pressured in the head.  On Wednesday morning, he states he got out of bed and was in a cold sweat - he states he pajamas were soaked in sweat and he felt chilled. He experienced brief numbness of the left arm down to his fingers.  On Thursday, he felt fine - he went out to snow blow.  Friday he developed headaches and head pressure. At night, he felt his breathing was labored as he was "gasping for air."  On Saturday and Sunday, he sat and laid around all day.  On Monday, he wakes up at 125 AM and his blood pressure was 165/104 and it remained elevated for 3 separate readings.    Patient was then admitted on 2/10/21 with weakness and confusion, then on 2/11 MD noted ?word finding difficulty, slurred speech, possible subtle right upper lip droop, and possibly some mild right hemineglect? with MRI showing likely embolic source of infarcts and cerebral MRA with possible acute thrombus. His symptoms the day after the vaccine seem a bit suspicious for TIA. Per Drug Policy Manager call to Moderna, no current reports of TIA/stroke secondary to COVID vaccine, so time course may be incidental. Patient had echocardiogram without right to left shunt or clot identified, no known history of atrial fibrillation. Was monitored on telemetry for the duration of his hospitalization without any noted arrhythmias, discharged on e patch for 14-day outpatient monitoring.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Magnetic resonance imaging abnormal, Magnetic resonance imaging brain abnormal, Transient ischaemic attack
Clinical narrative: Patient admitted for fatigue, dry throat, generalized weakness, dyspnea on exertion. Durion hospitalization was identified to have an acute ischemic CVA -- unclear time of symptom onset, possibly evening of 2/9 or morning of 2/10. Time course suspicious for possible COVID vaccine adverse event. He received his first Moderna COVID vaccine on 2/2/21 per WIR.   Per PCP note on 2/9/21:   Patient is here today accompanied by his wife with concerns for fatigue, headaches, head pressure and tremors. Received vaccine last Tuesday. Around 10 PM that evening he developed pressured in the head.  On Wednesday morning, he states he got out of bed and was in a cold sweat - he states he pajamas were soaked in sweat and he felt chilled. He experienced brief numbness of the left arm down to his fingers.  On Thursday, he felt fine - he went out to snow blow.  Friday he developed headaches and head pressure. At night, he felt his breathing was labored as he was "gasping for air."  On Saturday and Sunday, he sat and laid around all day.  On Monday, he wakes up at 125 AM and his blood pressure was 165/104 and it remained elevated for 3 separate readings.    Patient was then admitted on 2/10/21 with weakness and confusion, then on 2/11 MD noted ?word finding difficulty, slurred speech, possible subtle right upper lip droop, and possibly some mild right hemineglect? with MRI showing likely embolic source of infarcts and cerebral MRA with possible acute thrombus. His symptoms the day after the vaccine seem a bit suspicious for TIA. Per Drug Policy Manager call to Moderna, no current reports of TIA/stroke secondary to COVID vaccine, so time course may be incidental. Patient had echocardiogram without right to left shunt or clot identified, no known history of atrial fibrillation. Was monitored on telemetry for the duration of his hospitalization without any noted arrhythmias, discharged on e patch for 14-day outpatient monitoring.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Patient admitted for fatigue, dry throat, generalized weakness, dyspnea on exertion. Durion hospitalization was identified to have an acute ischemic CVA -- unclear time of symptom onset, possibly evening of 2/9 or morning of 2/10. Time course suspicious for possible COVID vaccine adverse event. He received his first Moderna COVID vaccine on 2/2/21 per WIR.   Per PCP note on 2/9/21:   Patient is here today accompanied by his wife with concerns for fatigue, headaches, head pressure and tremors. Received vaccine last Tuesday. Around 10 PM that evening he developed pressured in the head.  On Wednesday morning, he states he got out of bed and was in a cold sweat - he states he pajamas were soaked in sweat and he felt chilled. He experienced brief numbness of the left arm down to his fingers.  On Thursday, he felt fine - he went out to snow blow.  Friday he developed headaches and head pressure. At night, he felt his breathing was labored as he was "gasping for air."  On Saturday and Sunday, he sat and laid around all day.  On Monday, he wakes up at 125 AM and his blood pressure was 165/104 and it remained elevated for 3 separate readings.    Patient was then admitted on 2/10/21 with weakness and confusion, then on 2/11 MD noted ?word finding difficulty, slurred speech, possible subtle right upper lip droop, and possibly some mild right hemineglect? with MRI showing likely embolic source of infarcts and cerebral MRA with possible acute thrombus. His symptoms the day after the vaccine seem a bit suspicious for TIA. Per Drug Policy Manager call to Moderna, no current reports of TIA/stroke secondary to COVID vaccine, so time course may be incidental. Patient had echocardiogram without right to left shunt or clot identified, no known history of atrial fibrillation. Was monitored on telemetry for the duration of his hospitalization without any noted arrhythmias, discharged on e patch for 14-day outpatient monitoring.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: That night I had severe itching, not at the injection site but just random areas. The next day I noticed scattered hives. I went to urgent care the next day and they gave me a steroid injection and then over the next seven days I took oral steroids on a taper.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: STarted with rash ar 2/3 PM Lasted tiLL 2-5 took BeNedriL 50 mg every 4to6hr StiLL Red & KNot
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Nodule, Rash
Clinical narrative: STarted with rash ar 2/3 PM Lasted tiLL 2-5 took BeNedriL 50 mg every 4to6hr StiLL Red & KNot
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: covid arm: rash starting 7 days after vaccine. clearing up after 2-3 days
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: covid arm: rash starting 7 days after vaccine. clearing up after 2-3 days
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Head injury
Clinical narrative: severe chills      nausea       low grade fever     stomach cramps     PASSED OUT/Fainted
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: severe chills      nausea       low grade fever     stomach cramps     PASSED OUT/Fainted
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: severe chills      nausea       low grade fever     stomach cramps     PASSED OUT/Fainted
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: severe chills      nausea       low grade fever     stomach cramps     PASSED OUT/Fainted
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient received COVID #1 the afternoon of 1/26/2021 and she was fine until 4PM on 1/27/2021 when she threw up very hard while sitting up in a chair. After cleaning up she laid on the couch watching TV throwing up lightly 3 to 4 times and I gave her over the counter nausia medicine which helped. She was very cold so I put warmed blankets on her. She had nothing to eat or any pills that evening. To bed by 10PM and she fell asleep. After an hour she awoke abruptly and had to get up because she was nausiated, was wheezing, go to bathroom, thirsty and was very uncomfortable in general. This happened about every 15 to 20 minutes all night until we both fell asleep about 4AM.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Discomfort, Feeling cold, Nausea, Sleep disorder
Clinical narrative: Patient received COVID #1 the afternoon of 1/26/2021 and she was fine until 4PM on 1/27/2021 when she threw up very hard while sitting up in a chair. After cleaning up she laid on the couch watching TV throwing up lightly 3 to 4 times and I gave her over the counter nausia medicine which helped. She was very cold so I put warmed blankets on her. She had nothing to eat or any pills that evening. To bed by 10PM and she fell asleep. After an hour she awoke abruptly and had to get up because she was nausiated, was wheezing, go to bathroom, thirsty and was very uncomfortable in general. This happened about every 15 to 20 minutes all night until we both fell asleep about 4AM.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thirst, Vomiting, Wheezing
Clinical narrative: Patient received COVID #1 the afternoon of 1/26/2021 and she was fine until 4PM on 1/27/2021 when she threw up very hard while sitting up in a chair. After cleaning up she laid on the couch watching TV throwing up lightly 3 to 4 times and I gave her over the counter nausia medicine which helped. She was very cold so I put warmed blankets on her. She had nothing to eat or any pills that evening. To bed by 10PM and she fell asleep. After an hour she awoke abruptly and had to get up because she was nausiated, was wheezing, go to bathroom, thirsty and was very uncomfortable in general. This happened about every 15 to 20 minutes all night until we both fell asleep about 4AM.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Nausea, Paraesthesia
Clinical narrative: rash; a bit nauseous; I felt tingling my tongue; light headed; top of my palate strange; taste of metal in my mouth; swelling; inside of mouth swelling; loss of vision; something weird on liver; lumps on skin; kidney is hurting; vaccine took away all the depression; This is a spontaneous report from a contactable consumer (the patient). A 67-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 10Feb2021 (at the age of 67-years-old) for COVID-19 immunization. Medical history included high blood pressure, glaucoma and depressed from an unknown date. Concomitant medications were not reported. The patient had taken 10mg of antihistamine around 30 minutes before the vaccine (unspecified). The patient previously took iodine and experienced allergic reaction and flu vaccine and had an allergic reaction. On 10Feb2021, the moment they finished putting the shot, the patient experienced rash, nausea, swelling, tingling on the tongue, palette and inside of mouth, top of palate strange, metal taste, and light headed (felt like she was flying). The patient was hospitalized for the events rash, nausea, swelling, tingling on the tongue, palette and inside of mouth, top of palate strange, metal taste, felt nauseous, and light headed on an unknown date. The patient experienced a loss of vision reported as she cannot read her computer because the letters are gray; something weird on her liver, has lumps on her skin and kidney is hurting on an unknown date. The patient also experienced the vaccine took away all the depression and has made her active, now does everything and has been super positive, feels her internal battery is full. The clinical outcome of the events rash, nausea, paraesthesia oral, dizziness, palatal disorder, dysgeuisia, swelling, mouth swelling, blindness, liver disorder, skin swelling, renal pain and therapeutic response unexpected was unknown.    The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness, Dizziness, Dysgeusia, Liver disorder, Mouth swelling
Clinical narrative: rash; a bit nauseous; I felt tingling my tongue; light headed; top of my palate strange; taste of metal in my mouth; swelling; inside of mouth swelling; loss of vision; something weird on liver; lumps on skin; kidney is hurting; vaccine took away all the depression; This is a spontaneous report from a contactable consumer (the patient). A 67-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 10Feb2021 (at the age of 67-years-old) for COVID-19 immunization. Medical history included high blood pressure, glaucoma and depressed from an unknown date. Concomitant medications were not reported. The patient had taken 10mg of antihistamine around 30 minutes before the vaccine (unspecified). The patient previously took iodine and experienced allergic reaction and flu vaccine and had an allergic reaction. On 10Feb2021, the moment they finished putting the shot, the patient experienced rash, nausea, swelling, tingling on the tongue, palette and inside of mouth, top of palate strange, metal taste, and light headed (felt like she was flying). The patient was hospitalized for the events rash, nausea, swelling, tingling on the tongue, palette and inside of mouth, top of palate strange, metal taste, felt nauseous, and light headed on an unknown date. The patient experienced a loss of vision reported as she cannot read her computer because the letters are gray; something weird on her liver, has lumps on her skin and kidney is hurting on an unknown date. The patient also experienced the vaccine took away all the depression and has made her active, now does everything and has been super positive, feels her internal battery is full. The clinical outcome of the events rash, nausea, paraesthesia oral, dizziness, palatal disorder, dysgeuisia, swelling, mouth swelling, blindness, liver disorder, skin swelling, renal pain and therapeutic response unexpected was unknown.    The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Palatal disorder, Paraesthesia oral, Rash, Renal pain
Clinical narrative: rash; a bit nauseous; I felt tingling my tongue; light headed; top of my palate strange; taste of metal in my mouth; swelling; inside of mouth swelling; loss of vision; something weird on liver; lumps on skin; kidney is hurting; vaccine took away all the depression; This is a spontaneous report from a contactable consumer (the patient). A 67-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 10Feb2021 (at the age of 67-years-old) for COVID-19 immunization. Medical history included high blood pressure, glaucoma and depressed from an unknown date. Concomitant medications were not reported. The patient had taken 10mg of antihistamine around 30 minutes before the vaccine (unspecified). The patient previously took iodine and experienced allergic reaction and flu vaccine and had an allergic reaction. On 10Feb2021, the moment they finished putting the shot, the patient experienced rash, nausea, swelling, tingling on the tongue, palette and inside of mouth, top of palate strange, metal taste, and light headed (felt like she was flying). The patient was hospitalized for the events rash, nausea, swelling, tingling on the tongue, palette and inside of mouth, top of palate strange, metal taste, felt nauseous, and light headed on an unknown date. The patient experienced a loss of vision reported as she cannot read her computer because the letters are gray; something weird on her liver, has lumps on her skin and kidney is hurting on an unknown date. The patient also experienced the vaccine took away all the depression and has made her active, now does everything and has been super positive, feels her internal battery is full. The clinical outcome of the events rash, nausea, paraesthesia oral, dizziness, palatal disorder, dysgeuisia, swelling, mouth swelling, blindness, liver disorder, skin swelling, renal pain and therapeutic response unexpected was unknown.    The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.