chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Blood test, Nausea, Ultrasound scan, Vomiting
Clinical narrative: upper abdominal pain; Nausea; Vomiting; This is a spontaneous report from an Other Health Professional.  A 48-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration in the right arm at 48-years-old on 31Dec2020 at 15:15 at a single dose for COVID-19 immunization; administered at a hospital. The patient did not receive any other vaccine within four weeks prior of receiving bnt162b2. Medical history included non-alcoholic steatohepatitis (NASH liver disease) from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, endometriosis from an unknown date and unknown if ongoing, penicillin allergy from an unknown date and unknown if ongoing, gluten sensitivity from an unknown date and unknown if ongoing, sulfonamide allergy from an unknown date and unknown if ongoing , hibiclens soap allergy from an unknown date and unknown if ongoing, pancreatitis from an unknown date and unknown if ongoing.  Concomitant medications included colestipol (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC), levothyroxine sodium (UNITHROID), liothyronine (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unspecified date to an unspecified date.  The patient previously took pregabalin (LYRICA), clindamycin (MANUFACTURER UNKNOWN), buprenorphine (BUTRANS) and experienced allergies from an unknown date and unknown if ongoing.  On 05Jan2021 at 19:00, the patient experienced: upper abdominal pain (non-serious), nausea (non-serious), and vomiting (non-serious); with no treatment received. Adverse event: About five days after the first dose, the patient started to have upper abdominal pain, nausea and vomiting. The pain and gastrointestinal (GI) issues that took place were similar to when the patient had experienced pancreatitis. The patient then contacted her primary care physician (PCP) and GI/Liver doctor. The issues cleared up within about 4-5 days of being on a clear liquid diet and rest. The patient had an ultrasound and blood work one week later, both showing no signs of common bile duct blockage or pancreatic issues.  The patient underwent lab tests and procedures which included blood work and ultrasound: no signs of common bile duct blockage or pancreatic issues on an unknown date.  The clinical outcome of the events was recovered on an unspecified date. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling jittery, Flushing, Heart rate increased, Oropharyngeal discomfort
Clinical narrative: scratchy throat; Felt dizzy; jittery; flushed; HR elevated by NSR; This is a spontaneous report from a contactable pharmacist. A 27-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), intramuscularly at the right arm, on 25Jan2021 08:45, at single dose, for covid-19 immunization. Medical history included ongoing acne; no known allergies. Concomitant medication included a prescription medicine for acne. The vaccine was received in a workplace clinic. The patient felt dizzy, jittery, flushed and, heart rate (HR) elevated by normal sinus rhythm (NSR). All these adverse events happened on 25Jan2021 09:15. She was then monitored for greater than 1 hour with symptoms occurring on and off during that period. At 10:25 on 25Jan2021 she felt flushed again with report of scratchy throat. No distress noted; oxygen sats was 100% on 25Jan2021; no itching or hives noted; and no swelling of the face or airway. Since she continued to have symptoms, she was placed in a wheelchair and taken to the emergency room (ER). No treatment was received for these adverse events. At the time of the report, the patient recovered from the adverse events on Jan2021.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling jittery, Flushing, Heart rate, Heart rate increased
Clinical narrative: scratchy throat; Felt dizzy; jittery; flushed; HR elevated by NSR; This is a spontaneous report from a contactable pharmacist. A 27-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), intramuscularly at the right arm, on 25Jan2021 08:45, at single dose, for covid-19 immunization. Medical history included ongoing acne; no known allergies. Concomitant medication included a prescription medicine for acne. The vaccine was received in a workplace clinic. The patient felt dizzy, jittery, flushed and, heart rate (HR) elevated by normal sinus rhythm (NSR). All these adverse events happened on 25Jan2021 09:15. She was then monitored for greater than 1 hour with symptoms occurring on and off during that period. At 10:25 on 25Jan2021 she felt flushed again with report of scratchy throat. No distress noted; oxygen sats was 100% on 25Jan2021; no itching or hives noted; and no swelling of the face or airway. Since she continued to have symptoms, she was placed in a wheelchair and taken to the emergency room (ER). No treatment was received for these adverse events. At the time of the report, the patient recovered from the adverse events on Jan2021.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Investigation, Oxygen saturation, Throat irritation
Clinical narrative: scratchy throat; Felt dizzy; jittery; flushed; HR elevated by NSR; This is a spontaneous report from a contactable pharmacist. A 27-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), intramuscularly at the right arm, on 25Jan2021 08:45, at single dose, for covid-19 immunization. Medical history included ongoing acne; no known allergies. Concomitant medication included a prescription medicine for acne. The vaccine was received in a workplace clinic. The patient felt dizzy, jittery, flushed and, heart rate (HR) elevated by normal sinus rhythm (NSR). All these adverse events happened on 25Jan2021 09:15. She was then monitored for greater than 1 hour with symptoms occurring on and off during that period. At 10:25 on 25Jan2021 she felt flushed again with report of scratchy throat. No distress noted; oxygen sats was 100% on 25Jan2021; no itching or hives noted; and no swelling of the face or airway. Since she continued to have symptoms, she was placed in a wheelchair and taken to the emergency room (ER). No treatment was received for these adverse events. At the time of the report, the patient recovered from the adverse events on Jan2021.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Aphasia, Asthenia, Blood test normal, Chest X-ray normal
Clinical narrative: Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. 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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Disorientation, Dizziness, Dysarthria, Dysphagia
Clinical narrative: Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. 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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. 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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Impaired work ability, Limb discomfort, Mobility decreased, Muscle spasms
Clinical narrative: Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. 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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Pallor, Paraesthesia, Pyrexia
Clinical narrative: Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. 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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Urine analysis normal, Urticaria
Clinical narrative: Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. 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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Dizziness, Dysarthria, Dysphagia, Dyspnoea
Clinical narrative: Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. 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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Illness, Ocular discomfort, Pallor, Paraesthesia
Clinical narrative: Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. 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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test, Speech disorder, Throat tightness
Clinical narrative: Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. 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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Illness
Clinical narrative: Passed away; A spontaneous report was received from a healthcare professional concerning a 57-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the patient passed away.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (BATCH # 011L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   One of the officers received their first dose of Moderna COVID-19 on 21 Jan 2021 and passed away the next morning 22 Jan 2021. She did not have any other information about timing and circumstances. She did not know any of his health conditions but did know he had many serious chronic health conditions but again did not know what they were. Patient did not experience any symptoms right away and nothing within the next fifteen minutes under their observation. Reporter stated maybe during the night, he began to experience some symptoms and he passed away, but she was not aware of what the symptoms were. Nurse stated they reported it to VAERS (vaccine adverse event reporting system) (case # 269619), county public health department and state public health department. Reporter gave permission to contact.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was not applicable.  On 22 Jan 2021, the patient was past away due to the unknown cause. Autopsy results were unknown.; Reporter's Comments: This case concerns a 57-year- old male patient. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot # 011L20A). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: unkown cause of death
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Passed away; A spontaneous report was received from a healthcare professional concerning a 57-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the patient passed away.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (BATCH # 011L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   One of the officers received their first dose of Moderna COVID-19 on 21 Jan 2021 and passed away the next morning 22 Jan 2021. She did not have any other information about timing and circumstances. She did not know any of his health conditions but did know he had many serious chronic health conditions but again did not know what they were. Patient did not experience any symptoms right away and nothing within the next fifteen minutes under their observation. Reporter stated maybe during the night, he began to experience some symptoms and he passed away, but she was not aware of what the symptoms were. Nurse stated they reported it to VAERS (vaccine adverse event reporting system) (case # 269619), county public health department and state public health department. Reporter gave permission to contact.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was not applicable.  On 22 Jan 2021, the patient was past away due to the unknown cause. Autopsy results were unknown.; Reporter's Comments: This case concerns a 57-year- old male patient. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot # 011L20A). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: unkown cause of death
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Swollen tongue
Clinical narrative: heart palpitations; tongue swelling; This is a spontaneous report from a contactable consumer  reporting for herself.  A 67-years-old female patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EL9262) vaccine , via an unspecified route of administration in the left arm  on  27Jan2021 18:00 at single dose for covid-19 immunisation .  Medical history included histamine issues, allergy to Naproxen, Sulfa, bee sting, eggs.  The patient experienced heart palpitations and  tongue swelling  on 27Jan2021 19:30 with outcome of recovering.   The patient took a Zyrtec before the vaccine and  immediately after the vaccine she was fine. It was about 90 minutes after the vaccine while the patient was at home that she felt her tongue swelling and  had heart palpitations. She took another Zyrtec and the palpitations and tongue swelling went down.  Further information has been requested
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Swollen tongue
Clinical narrative: heart palpitations; tongue swelling; This is a spontaneous report from a contactable consumer  reporting for herself.  A 67-years-old female patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EL9262) vaccine , via an unspecified route of administration in the left arm  on  27Jan2021 18:00 at single dose for covid-19 immunisation .  Medical history included histamine issues, allergy to Naproxen, Sulfa, bee sting, eggs.  The patient experienced heart palpitations and  tongue swelling  on 27Jan2021 19:30 with outcome of recovering.   The patient took a Zyrtec before the vaccine and  immediately after the vaccine she was fine. It was about 90 minutes after the vaccine while the patient was at home that she felt her tongue swelling and  had heart palpitations. She took another Zyrtec and the palpitations and tongue swelling went down.  Further information has been requested
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Headache, Urticaria
Clinical narrative: Swelling of throat area and face. Rash on right side of throat but went away over time.; Swelling of throat area and face. Rash on right side of throat but went away over time.; Swelling of throat area and face. Rash on right side of throat but went away over time.; This is a spontaneous report from a contactable consumer (Patient) A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot Lot EL9262) on 28Jan2021 at 09:30 at single dose in Right arm for COVID-19 immunization. Patient was not pregnant. Medical history included High Blood pressure.No known allergy. Concomitant medication included irbesartan. On 28Jan2021 the patient experienced swelling of throat area and face and rash on right side of throat but went away over time. Events required Doctor/other healthcare professional office/clinic visit. Patient was teated with Benadryl. Final outcome of all the events was recovering.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal enanthema, Pharyngeal swelling, Swelling face
Clinical narrative: Swelling of throat area and face. Rash on right side of throat but went away over time.; Swelling of throat area and face. Rash on right side of throat but went away over time.; Swelling of throat area and face. Rash on right side of throat but went away over time.; This is a spontaneous report from a contactable consumer (Patient) A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot Lot EL9262) on 28Jan2021 at 09:30 at single dose in Right arm for COVID-19 immunization. Patient was not pregnant. Medical history included High Blood pressure.No known allergy. Concomitant medication included irbesartan. On 28Jan2021 the patient experienced swelling of throat area and face and rash on right side of throat but went away over time. Events required Doctor/other healthcare professional office/clinic visit. Patient was teated with Benadryl. Final outcome of all the events was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Hyperhidrosis, Rash, Skin warm
Clinical narrative: the arm i received the injection felt like it was on fire; The opposite arm had a rash on it; I was freezing at night and i woke up in a sweat; I was freezing at night and i woke up in a sweat; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at 09:45 at single dose in right arm for COVID-19 immunisation at the age of 29-year-old. Lot number was EL9262. Medical history was none. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at 09:45 at single dose in right arm for COVID-19 immunisation at the age of 29-year-old (lot number was EL3248). Concomitant medications included desogestrel, ethinylestradiol (ISIBLOOM) for birth control, ESCITALOPRAM OXALATE (LEXAPRO), vitamin D. On 28Jan2021 at 07:45, the patient woke up and the arm where she received the injection felt like it was on fire; the opposite arm had a rash on it; the patient took benadryl that morning and at night after she got home from work. On 28Jan2021, the patient was freezing at night and he woke up in a sweat. On 29Jan2021, the rash looks worse.  The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Hyperhidrosis, Rash, Vaccination site pain
Clinical narrative: the arm i received the injection felt like it was on fire; The opposite arm had a rash on it; I was freezing at night and i woke up in a sweat; I was freezing at night and i woke up in a sweat; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at 09:45 at single dose in right arm for COVID-19 immunisation at the age of 29-year-old. Lot number was EL9262. Medical history was none. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at 09:45 at single dose in right arm for COVID-19 immunisation at the age of 29-year-old (lot number was EL3248). Concomitant medications included desogestrel, ethinylestradiol (ISIBLOOM) for birth control, ESCITALOPRAM OXALATE (LEXAPRO), vitamin D. On 28Jan2021 at 07:45, the patient woke up and the arm where she received the injection felt like it was on fire; the opposite arm had a rash on it; the patient took benadryl that morning and at night after she got home from work. On 28Jan2021, the patient was freezing at night and he woke up in a sweat. On 29Jan2021, the rash looks worse.  The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
Age: 72.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Asthenia, Blood test, Fall, Gait disturbance, Muscle spasms
Clinical narrative: day 0: got the shot, day 1: ran a fever, day 4: started feeling tingling all over, went to the e.r. day7: could not get into vehicle, day 8: fell down and went to hospital and stayed a an inpatient.  diagnosed in hospital with Guillain-Barre syndrome which the provider attributed to to moderna vaccination
Age: 72.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: day 0: got the shot, day 1: ran a fever, day 4: started feeling tingling all over, went to the e.r. day7: could not get into vehicle, day 8: fell down and went to hospital and stayed a an inpatient.  diagnosed in hospital with Guillain-Barre syndrome which the provider attributed to to moderna vaccination
Age: 72.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Fall, Guillain-Barre syndrome, Lumbar puncture, Paraesthesia, Pyrexia
Clinical narrative: day 0: got the shot, day 1: ran a fever, day 4: started feeling tingling all over, went to the e.r. day7: could not get into vehicle, day 8: fell down and went to hospital and stayed a an inpatient.  diagnosed in hospital with Guillain-Barre syndrome which the provider attributed to to moderna vaccination
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Flushing, Hypertension, Pruritus, Urticaria
Clinical narrative: She received her 1st vaccine without any adverse or side effects.  Within 30 seconds of her 2nd vaccine she became flushed, within minutes she developed hives starting on her hands and then becoming more generalized, as well as itchy palms.  She also was hypertensive.  The COVID vaccine clinic administered epinephrine and transfer her to the emergency department where she was given prednisone, Benadryl, and famotidine.  ED notes do indicate she had some mild expiratory wheezing but on further discussion with her today this is a consistent finding after being diagnosed with asthma last year (more on this below).  She was monitored for over 3 hours and discharged home. Her itching resolved in the ED, hives resolved about 3 hours after discharge and other symptoms resolved around 24 hours post vaccine.   She did have labs drawn in the ED: troponin and C4 WNL. CBC showed leukocytosis with lymphocytosis and eosinophilia.   No personal history of seasonal, perennial, food, or bee sting allergies; asthma history as below. She did have an episode of bilateral eye swelling in December that was evaluated by her PCP; she was treated with benadryl & prednisone and this took 3 days to resolve. She has no other history of anaphylaxis, hives or angioedema. She was able to show me pictures of this today.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Complement factor C4 increased, Eosinophil count increased, Eye pruritus, Flushing, Hypertension
Clinical narrative: She received her 1st vaccine without any adverse or side effects.  Within 30 seconds of her 2nd vaccine she became flushed, within minutes she developed hives starting on her hands and then becoming more generalized, as well as itchy palms.  She also was hypertensive.  The COVID vaccine clinic administered epinephrine and transfer her to the emergency department where she was given prednisone, Benadryl, and famotidine.  ED notes do indicate she had some mild expiratory wheezing but on further discussion with her today this is a consistent finding after being diagnosed with asthma last year (more on this below).  She was monitored for over 3 hours and discharged home. Her itching resolved in the ED, hives resolved about 3 hours after discharge and other symptoms resolved around 24 hours post vaccine.   She did have labs drawn in the ED: troponin and C4 WNL. CBC showed leukocytosis with lymphocytosis and eosinophilia.   No personal history of seasonal, perennial, food, or bee sting allergies; asthma history as below. She did have an episode of bilateral eye swelling in December that was evaluated by her PCP; she was treated with benadryl & prednisone and this took 3 days to resolve. She has no other history of anaphylaxis, hives or angioedema. She was able to show me pictures of this today.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphocyte count increased, Pruritus, Urticaria, Wheezing, White blood cell count increased
Clinical narrative: She received her 1st vaccine without any adverse or side effects.  Within 30 seconds of her 2nd vaccine she became flushed, within minutes she developed hives starting on her hands and then becoming more generalized, as well as itchy palms.  She also was hypertensive.  The COVID vaccine clinic administered epinephrine and transfer her to the emergency department where she was given prednisone, Benadryl, and famotidine.  ED notes do indicate she had some mild expiratory wheezing but on further discussion with her today this is a consistent finding after being diagnosed with asthma last year (more on this below).  She was monitored for over 3 hours and discharged home. Her itching resolved in the ED, hives resolved about 3 hours after discharge and other symptoms resolved around 24 hours post vaccine.   She did have labs drawn in the ED: troponin and C4 WNL. CBC showed leukocytosis with lymphocytosis and eosinophilia.   No personal history of seasonal, perennial, food, or bee sting allergies; asthma history as below. She did have an episode of bilateral eye swelling in December that was evaluated by her PCP; she was treated with benadryl & prednisone and this took 3 days to resolve. She has no other history of anaphylaxis, hives or angioedema. She was able to show me pictures of this today.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Patient developed Guillen Barre Syndrome
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF test, Guillain-Barre syndrome
Clinical narrative: Patient developed Guillen Barre Syndrome
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Paraesthesia oral, Swelling face
Clinical narrative: Swelling of tissue above and under eyes; Swelling of left cheek; Pressure in lymph nodes; Nausea; This is a spontaneous report from a contactable consumer, the patient.  A 65-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), via an unspecified route of administration in the right arm on 03Feb2021 at 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history included high creatinine levels and shellfish allergy; all from unknown dates and unknown if ongoing.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN) and simvastatin (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 03Feb2021 at 13:00, the patient experienced swelling of tissue above and under eyes, swelling of left cheek, pressure in lymph nodes, and nausea; all serious for being life threatening. The patient was treated with diphenhydramine hydrochloride (BENADRYL). The clinical outcomes of swelling of tissue above and under eyes, swelling of left cheek, pressure in lymph nodes, and nausea were recovering.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine, Eye swelling, Lymphadenopathy, Nausea, Swelling face
Clinical narrative: Swelling of tissue above and under eyes; Swelling of left cheek; Pressure in lymph nodes; Nausea; This is a spontaneous report from a contactable consumer, the patient.  A 65-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), via an unspecified route of administration in the right arm on 03Feb2021 at 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history included high creatinine levels and shellfish allergy; all from unknown dates and unknown if ongoing.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN) and simvastatin (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 03Feb2021 at 13:00, the patient experienced swelling of tissue above and under eyes, swelling of left cheek, pressure in lymph nodes, and nausea; all serious for being life threatening. The patient was treated with diphenhydramine hydrochloride (BENADRYL). The clinical outcomes of swelling of tissue above and under eyes, swelling of left cheek, pressure in lymph nodes, and nausea were recovering.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chills, Hypertension, Rash
Clinical narrative: Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; This is a spontaneous report from a contactable consumer (patient).  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9269), via an unspecified route of administration into left arm on 06Feb2021, at 15:15 as  first single dose for covid-19 immunization.  Medical history included high blood pressure from an unknown date, known allergies to peanuts, tree nuts from an unknown date (elaborated as allergies to peanuts, non-steroidal-anti-inflammatory drugs (NSAIDs), tree nuts, penicillin), from unknown dates.  Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) and unspecified multivitamins. No other-vaccines were given with four weeks.  On 06Feb2021, at 15:45, the patient experienced adverse event: anaphylaxis reaction. high blood pressure. body shivering. rash on neck and chest. The events were serious as they were life-threatening. The events were noted as resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and was  life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood pressure measurement: high on 06Feb2021.  Therapeutic measures were taken as a result of the adverse events; dexamethasone sodium phos- diphenhydramine (BENADRYL), famotidine. No covid infection was noted prior to vaccination.  No covid test has been administered post vaccination. The outcome of events was recovered in Feb2021.