chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Pulmonary Embolism; This is a spontaneous report from a contactable consumer. A 72-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 11Feb2021 12:00(Age at vaccination 72 years) as 2nd dose, single for covid-19 immunisation.  Medical history included, psoriatic Arthritis, RA(Rheumatoid arthritis) .The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 21Jan2021 02:00 as 1st dose, single for covid-19 immunisation. On 13Feb2021 12:00 the patient experienced pulmonary embolism leads to hospitalization, life threatening . The patient was hospitalized for pulmonary embolism for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 13Feb2021. Patient received treatment of clot buster blood thinners. The outcome of event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Angioedema, Nausea, Urticaria, Vomiting
Clinical narrative: Fever, lounge swelling, hives, check pains
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram, Pyrexia, Swollen tongue, Urticaria
Clinical narrative: Fever, lounge swelling, hives, check pains
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Dizziness, Fatigue, Full blood count, Metabolic function test
Clinical narrative: Developed dizziness , light sensitivity the next day last about 2 weeks. Soon after that I noticed a ringing in my ears that won?t go away.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Developed dizziness , light sensitivity the next day last about 2 weeks. Soon after that I noticed a ringing in my ears that won?t go away.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Dizziness, Sensitive skin, Tinnitus
Clinical narrative: Developed dizziness , light sensitivity the next day last about 2 weeks. Soon after that I noticed a ringing in my ears that won?t go away.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Eye movement disorder, Hyperhidrosis, Immediate post-injection reaction, Injection site bruising
Clinical narrative: Previously healthy 16-year-old female presents with syncope after COVID-19 vaccine.  In vaccine clinic here. Soon after receiving vaccine, felt light headed and nauseous.  Sat down and soon after had a syncopal episode. Quickly came back to.  CART called and brought to the ED.  On arrival to the ED, continued with some dizziness, but symptoms overall improving.  By the time of evaluation, symptoms completely resolved, ambulating without difficulty.  Denies other symptoms or complaints. No recent illness. Back to baseline without distress, nontoxic. Tolerating PO.  Counseled on likely etiology, strict return precautions, and close outpatient followup.  d/c'd home in good clinical condition.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site haemorrhage, Lip discolouration, Malaise, Pallor
Clinical narrative: Previously healthy 16-year-old female presents with syncope after COVID-19 vaccine.  In vaccine clinic here. Soon after receiving vaccine, felt light headed and nauseous.  Sat down and soon after had a syncopal episode. Quickly came back to.  CART called and brought to the ED.  On arrival to the ED, continued with some dizziness, but symptoms overall improving.  By the time of evaluation, symptoms completely resolved, ambulating without difficulty.  Denies other symptoms or complaints. No recent illness. Back to baseline without distress, nontoxic. Tolerating PO.  Counseled on likely etiology, strict return precautions, and close outpatient followup.  d/c'd home in good clinical condition.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram normal, Nausea, Syncope
Clinical narrative: Previously healthy 16-year-old female presents with syncope after COVID-19 vaccine.  In vaccine clinic here. Soon after receiving vaccine, felt light headed and nauseous.  Sat down and soon after had a syncopal episode. Quickly came back to.  CART called and brought to the ED.  On arrival to the ED, continued with some dizziness, but symptoms overall improving.  By the time of evaluation, symptoms completely resolved, ambulating without difficulty.  Denies other symptoms or complaints. No recent illness. Back to baseline without distress, nontoxic. Tolerating PO.  Counseled on likely etiology, strict return precautions, and close outpatient followup.  d/c'd home in good clinical condition.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy bone marrow, Headache, Neutropenia, Neutrophil count decreased, Pain
Clinical narrative: Prolonged neutropenia
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Skin lesion, Ultrasound scan, White blood cell count decreased
Clinical narrative: Prolonged neutropenia
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy bone marrow, Full blood count, Neutropenia
Clinical narrative: Prolonged neutropenia
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin reaction, Urticaria
Clinical narrative: Approximately 6 1/2 hours after second vaccination patient developed diffuse urticaria and facial swelling. Seen in Hospital ER and admitted for treatment - included IV Antihistamines and Steroids (Prednisone). No hypotension or respiratory compromise.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Approximately 6 1/2 hours after second vaccination patient developed diffuse urticaria and facial swelling. Seen in Hospital ER and admitted for treatment - included IV Antihistamines and Steroids (Prednisone). No hypotension or respiratory compromise.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Headache, Pyrexia, Rectal haemorrhage
Clinical narrative: This spontaneous report received from a patient concerned a 78 year old white and not hispanic or latino female. The patient's height, and weight were not reported. The patient's past medical history included endoscopy, and concurrent conditions included high blood pressure (borderline). The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: 07-AUG-2021) dose was not reported, administered on 05-JUN-2021 at 12:22 on left arm for prophylactic vaccination. . Concomitant medications included lisinopril for borderline hypertension. On 06-JUN-2021, the patient experienced blood from rectum and flatulence at around 04:00 to 05:00, terrible stomach pains, gurgling in stomach and fever at 04:00, sleeps too much, terrible headaches and  water pouring off head that could not seen by her eyes. On 11-JUN-2021, the patient experienced weight loss. On an unspecified date, the patient experienced exhausted. The patient was unable to drive. The patient was use the kotex pad. When the patient weighed then the patient had found lost her 5 pound weight. The patient had consistently been the same weight, never moved. The patient was afraid to eat. The patient visited primary care physician office for blood from rectum, flatulence and terrible stomach pains. On 05-MAY-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. Treatment medications (dates unspecified) included: Extra Strength Tylenol (paracetamol) and Gas-X (simeticone). The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood from rectum, flatulence, terrible stomach pains and gurgling in stomach  on 11-JUN-2021, and terrible headaches, and fever on 06-JUN-2021, had not recovered from weight loss, exhausted, and sleeps too much, and the outcome of water pouring off head was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000182596. The suspected product quality complaint has been confirmed to be voided because the suspect product did not meet product quality complaint (PQC) criteria based on the product quality complaint (PQC) evaluation/investigation performed; Sender's Comments: V0: 20210627859-COVID-19 VACCINE AD26.COV2.S-Blood from rectum. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Flatulence, Gastrointestinal sounds abnormal, Headache, Hyperhidrosis
Clinical narrative: This spontaneous report received from a patient concerned a 78 year old white and not hispanic or latino female. The patient's height, and weight were not reported. The patient's past medical history included endoscopy, and concurrent conditions included high blood pressure (borderline). The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: 07-AUG-2021) dose was not reported, administered on 05-JUN-2021 at 12:22 on left arm for prophylactic vaccination. . Concomitant medications included lisinopril for borderline hypertension. On 06-JUN-2021, the patient experienced blood from rectum and flatulence at around 04:00 to 05:00, terrible stomach pains, gurgling in stomach and fever at 04:00, sleeps too much, terrible headaches and  water pouring off head that could not seen by her eyes. On 11-JUN-2021, the patient experienced weight loss. On an unspecified date, the patient experienced exhausted. The patient was unable to drive. The patient was use the kotex pad. When the patient weighed then the patient had found lost her 5 pound weight. The patient had consistently been the same weight, never moved. The patient was afraid to eat. The patient visited primary care physician office for blood from rectum, flatulence and terrible stomach pains. On 05-MAY-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. Treatment medications (dates unspecified) included: Extra Strength Tylenol (paracetamol) and Gas-X (simeticone). The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood from rectum, flatulence, terrible stomach pains and gurgling in stomach  on 11-JUN-2021, and terrible headaches, and fever on 06-JUN-2021, had not recovered from weight loss, exhausted, and sleeps too much, and the outcome of water pouring off head was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000182596. The suspected product quality complaint has been confirmed to be voided because the suspect product did not meet product quality complaint (PQC) criteria based on the product quality complaint (PQC) evaluation/investigation performed; Sender's Comments: V0: 20210627859-COVID-19 VACCINE AD26.COV2.S-Blood from rectum. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Pyrexia, Rectal haemorrhage, SARS-CoV-2 antibody test, Weight decreased
Clinical narrative: This spontaneous report received from a patient concerned a 78 year old white and not hispanic or latino female. The patient's height, and weight were not reported. The patient's past medical history included endoscopy, and concurrent conditions included high blood pressure (borderline). The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: 07-AUG-2021) dose was not reported, administered on 05-JUN-2021 at 12:22 on left arm for prophylactic vaccination. . Concomitant medications included lisinopril for borderline hypertension. On 06-JUN-2021, the patient experienced blood from rectum and flatulence at around 04:00 to 05:00, terrible stomach pains, gurgling in stomach and fever at 04:00, sleeps too much, terrible headaches and  water pouring off head that could not seen by her eyes. On 11-JUN-2021, the patient experienced weight loss. On an unspecified date, the patient experienced exhausted. The patient was unable to drive. The patient was use the kotex pad. When the patient weighed then the patient had found lost her 5 pound weight. The patient had consistently been the same weight, never moved. The patient was afraid to eat. The patient visited primary care physician office for blood from rectum, flatulence and terrible stomach pains. On 05-MAY-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. Treatment medications (dates unspecified) included: Extra Strength Tylenol (paracetamol) and Gas-X (simeticone). The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood from rectum, flatulence, terrible stomach pains and gurgling in stomach  on 11-JUN-2021, and terrible headaches, and fever on 06-JUN-2021, had not recovered from weight loss, exhausted, and sleeps too much, and the outcome of water pouring off head was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000182596. The suspected product quality complaint has been confirmed to be voided because the suspect product did not meet product quality complaint (PQC) criteria based on the product quality complaint (PQC) evaluation/investigation performed; Sender's Comments: V0: 20210627859-COVID-19 VACCINE AD26.COV2.S-Blood from rectum. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Pruritus
Clinical narrative: Rash on arm that went over complete body next day.  Extreme itching which could not be calmed.  Exhaustion.  Swelling in hands and feet.    Treatments:  6 day steroid, hydrocortisone cream 2.5%, acetaminophen, Xanax, Benedryl spray,
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Pruritus, Rash, Vaccination complication
Clinical narrative: Rash on arm that went over complete body next day.  Extreme itching which could not be calmed.  Exhaustion.  Swelling in hands and feet.    Treatments:  6 day steroid, hydrocortisone cream 2.5%, acetaminophen, Xanax, Benedryl spray,
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Peripheral swelling, Pruritus, Rash
Clinical narrative: Rash on arm that went over complete body next day.  Extreme itching which could not be calmed.  Exhaustion.  Swelling in hands and feet.    Treatments:  6 day steroid, hydrocortisone cream 2.5%, acetaminophen, Xanax, Benedryl spray,
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Patient received 2nd moderna vaccine on 06/11/21.  Patient started to develop red itchy spots and wells on her entire body and feet.  Patient seek medical care through a Dr.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash macular, Rash papular, Urticaria
Clinical narrative: Patient received 2nd moderna vaccine on 06/11/21.  Patient started to develop red itchy spots and wells on her entire body and feet.  Patient seek medical care through a Dr.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Babinski reflex test, Ear pain, Eye movement disorder, Facial pain
Clinical narrative: Look faint; lose consciousness; Uncontrollable jerking movements and convulsions; lightheadedness; Tingling in her arms and fingertips; Weakness; Muscle spasms; Uncontrollable jerking movements and convulsions; Tired; Shaking; Shaking; This is a spontaneous report from a contactable pharmacist. A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 05Jun2021 at 15:30 (Batch/Lot Number: EW0180) as 1ST DOSE, SINGLE (at the age of 31-years-old) for COVID-19 immunisation. Medical history included tremors, fibromyalgia, and asthma. The patient had no known drug allergy (NKDA). Reaction to TDAP vaccine (nausea). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if the patient has been tested for COVID-19 since the vaccination. The patient received the first Pfizer dose at 3:20pm. On a consent form, reaction to TDAP vaccine (nausea) and history (hx) of tremors and fibromyalgia were reported. The patient sat for her observation period. After a few minutes, the patient began to look faint. The patient stated lightheadedness, and she was given some water, juice, and some saltine crackers. The patient stated tingling in her arms and fingertips, and weakness-unable to raise the juice box to drink. The patient started to have muscle spasms and uncontrollable jerking movements and convulsions, still coherent, and breathing was not affected. The patient was lowered to the ground, with continued convulsions, worsening spasms, but reported no pain. The patient did not want her albuterol as breathing was okay and was provided 1/4 tablet of Benadryl to no avail. The patient began to state she was tired and began to lose consciousness, closing her eyes. The patient was still shaking when the paramedics came. Treatment for the events included Valium given at the hospital. The events resolved with sequel. The events required Emergency Room Visit and Physician Office Visit.; Sender's Comments: Based on the close temporal relationship, the association between the events syncope and loss of consciousness with BNT162b2 can not be completely 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: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis, Facial spasm, Fatigue, Grip strength decreased, Headache
Clinical narrative: Look faint; lose consciousness; Uncontrollable jerking movements and convulsions; lightheadedness; Tingling in her arms and fingertips; Weakness; Muscle spasms; Uncontrollable jerking movements and convulsions; Tired; Shaking; Shaking; This is a spontaneous report from a contactable pharmacist. A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 05Jun2021 at 15:30 (Batch/Lot Number: EW0180) as 1ST DOSE, SINGLE (at the age of 31-years-old) for COVID-19 immunisation. Medical history included tremors, fibromyalgia, and asthma. The patient had no known drug allergy (NKDA). Reaction to TDAP vaccine (nausea). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if the patient has been tested for COVID-19 since the vaccination. The patient received the first Pfizer dose at 3:20pm. On a consent form, reaction to TDAP vaccine (nausea) and history (hx) of tremors and fibromyalgia were reported. The patient sat for her observation period. After a few minutes, the patient began to look faint. The patient stated lightheadedness, and she was given some water, juice, and some saltine crackers. The patient stated tingling in her arms and fingertips, and weakness-unable to raise the juice box to drink. The patient started to have muscle spasms and uncontrollable jerking movements and convulsions, still coherent, and breathing was not affected. The patient was lowered to the ground, with continued convulsions, worsening spasms, but reported no pain. The patient did not want her albuterol as breathing was okay and was provided 1/4 tablet of Benadryl to no avail. The patient began to state she was tired and began to lose consciousness, closing her eyes. The patient was still shaking when the paramedics came. Treatment for the events included Valium given at the hospital. The events resolved with sequel. The events required Emergency Room Visit and Physician Office Visit.; Sender's Comments: Based on the close temporal relationship, the association between the events syncope and loss of consciousness with BNT162b2 can not be completely 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: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Impaired driving ability, Irregular breathing, Mobility decreased, Muscle spasms, Neck pain
Clinical narrative: Look faint; lose consciousness; Uncontrollable jerking movements and convulsions; lightheadedness; Tingling in her arms and fingertips; Weakness; Muscle spasms; Uncontrollable jerking movements and convulsions; Tired; Shaking; Shaking; This is a spontaneous report from a contactable pharmacist. A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 05Jun2021 at 15:30 (Batch/Lot Number: EW0180) as 1ST DOSE, SINGLE (at the age of 31-years-old) for COVID-19 immunisation. Medical history included tremors, fibromyalgia, and asthma. The patient had no known drug allergy (NKDA). Reaction to TDAP vaccine (nausea). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if the patient has been tested for COVID-19 since the vaccination. The patient received the first Pfizer dose at 3:20pm. On a consent form, reaction to TDAP vaccine (nausea) and history (hx) of tremors and fibromyalgia were reported. The patient sat for her observation period. After a few minutes, the patient began to look faint. The patient stated lightheadedness, and she was given some water, juice, and some saltine crackers. The patient stated tingling in her arms and fingertips, and weakness-unable to raise the juice box to drink. The patient started to have muscle spasms and uncontrollable jerking movements and convulsions, still coherent, and breathing was not affected. The patient was lowered to the ground, with continued convulsions, worsening spasms, but reported no pain. The patient did not want her albuterol as breathing was okay and was provided 1/4 tablet of Benadryl to no avail. The patient began to state she was tired and began to lose consciousness, closing her eyes. The patient was still shaking when the paramedics came. Treatment for the events included Valium given at the hospital. The events resolved with sequel. The events required Emergency Room Visit and Physician Office Visit.; Sender's Comments: Based on the close temporal relationship, the association between the events syncope and loss of consciousness with BNT162b2 can not be completely 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: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Seizure, Sleep disorder, Tremor
Clinical narrative: Look faint; lose consciousness; Uncontrollable jerking movements and convulsions; lightheadedness; Tingling in her arms and fingertips; Weakness; Muscle spasms; Uncontrollable jerking movements and convulsions; Tired; Shaking; Shaking; This is a spontaneous report from a contactable pharmacist. A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 05Jun2021 at 15:30 (Batch/Lot Number: EW0180) as 1ST DOSE, SINGLE (at the age of 31-years-old) for COVID-19 immunisation. Medical history included tremors, fibromyalgia, and asthma. The patient had no known drug allergy (NKDA). Reaction to TDAP vaccine (nausea). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if the patient has been tested for COVID-19 since the vaccination. The patient received the first Pfizer dose at 3:20pm. On a consent form, reaction to TDAP vaccine (nausea) and history (hx) of tremors and fibromyalgia were reported. The patient sat for her observation period. After a few minutes, the patient began to look faint. The patient stated lightheadedness, and she was given some water, juice, and some saltine crackers. The patient stated tingling in her arms and fingertips, and weakness-unable to raise the juice box to drink. The patient started to have muscle spasms and uncontrollable jerking movements and convulsions, still coherent, and breathing was not affected. The patient was lowered to the ground, with continued convulsions, worsening spasms, but reported no pain. The patient did not want her albuterol as breathing was okay and was provided 1/4 tablet of Benadryl to no avail. The patient began to state she was tired and began to lose consciousness, closing her eyes. The patient was still shaking when the paramedics came. Treatment for the events included Valium given at the hospital. The events resolved with sequel. The events required Emergency Room Visit and Physician Office Visit.; Sender's Comments: Based on the close temporal relationship, the association between the events syncope and loss of consciousness with BNT162b2 can not be completely 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: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye movement disorder, Loss of consciousness, Muscle spasms, Syncope
Clinical narrative: Look faint; lose consciousness; Uncontrollable jerking movements and convulsions; lightheadedness; Tingling in her arms and fingertips; Weakness; Muscle spasms; Uncontrollable jerking movements and convulsions; Tired; Shaking; Shaking; This is a spontaneous report from a contactable pharmacist. A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 05Jun2021 at 15:30 (Batch/Lot Number: EW0180) as 1ST DOSE, SINGLE (at the age of 31-years-old) for COVID-19 immunisation. Medical history included tremors, fibromyalgia, and asthma. The patient had no known drug allergy (NKDA). Reaction to TDAP vaccine (nausea). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if the patient has been tested for COVID-19 since the vaccination. The patient received the first Pfizer dose at 3:20pm. On a consent form, reaction to TDAP vaccine (nausea) and history (hx) of tremors and fibromyalgia were reported. The patient sat for her observation period. After a few minutes, the patient began to look faint. The patient stated lightheadedness, and she was given some water, juice, and some saltine crackers. The patient stated tingling in her arms and fingertips, and weakness-unable to raise the juice box to drink. The patient started to have muscle spasms and uncontrollable jerking movements and convulsions, still coherent, and breathing was not affected. The patient was lowered to the ground, with continued convulsions, worsening spasms, but reported no pain. The patient did not want her albuterol as breathing was okay and was provided 1/4 tablet of Benadryl to no avail. The patient began to state she was tired and began to lose consciousness, closing her eyes. The patient was still shaking when the paramedics came. Treatment for the events included Valium given at the hospital. The events resolved with sequel. The events required Emergency Room Visit and Physician Office Visit.; Sender's Comments: Based on the close temporal relationship, the association between the events syncope and loss of consciousness with BNT162b2 can not be completely 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: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Disease recurrence, Dizziness, Dyskinesia, Fatigue
Clinical narrative: Look faint; lose consciousness; Uncontrollable jerking movements and convulsions; lightheadedness; Tingling in her arms and fingertips; Weakness; Muscle spasms; Uncontrollable jerking movements and convulsions; Tired; Shaking; Shaking; This is a spontaneous report from a contactable pharmacist. A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 05Jun2021 at 15:30 (Batch/Lot Number: EW0180) as 1ST DOSE, SINGLE (at the age of 31-years-old) for COVID-19 immunisation. Medical history included tremors, fibromyalgia, and asthma. The patient had no known drug allergy (NKDA). Reaction to TDAP vaccine (nausea). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if the patient has been tested for COVID-19 since the vaccination. The patient received the first Pfizer dose at 3:20pm. On a consent form, reaction to TDAP vaccine (nausea) and history (hx) of tremors and fibromyalgia were reported. The patient sat for her observation period. After a few minutes, the patient began to look faint. The patient stated lightheadedness, and she was given some water, juice, and some saltine crackers. The patient stated tingling in her arms and fingertips, and weakness-unable to raise the juice box to drink. The patient started to have muscle spasms and uncontrollable jerking movements and convulsions, still coherent, and breathing was not affected. The patient was lowered to the ground, with continued convulsions, worsening spasms, but reported no pain. The patient did not want her albuterol as breathing was okay and was provided 1/4 tablet of Benadryl to no avail. The patient began to state she was tired and began to lose consciousness, closing her eyes. The patient was still shaking when the paramedics came. Treatment for the events included Valium given at the hospital. The events resolved with sequel. The events required Emergency Room Visit and Physician Office Visit.; Sender's Comments: Based on the close temporal relationship, the association between the events syncope and loss of consciousness with BNT162b2 can not be completely 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: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Muscle spasms, Paraesthesia, Seizure, Syncope
Clinical narrative: Look faint; lose consciousness; Uncontrollable jerking movements and convulsions; lightheadedness; Tingling in her arms and fingertips; Weakness; Muscle spasms; Uncontrollable jerking movements and convulsions; Tired; Shaking; Shaking; This is a spontaneous report from a contactable pharmacist. A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 05Jun2021 at 15:30 (Batch/Lot Number: EW0180) as 1ST DOSE, SINGLE (at the age of 31-years-old) for COVID-19 immunisation. Medical history included tremors, fibromyalgia, and asthma. The patient had no known drug allergy (NKDA). Reaction to TDAP vaccine (nausea). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if the patient has been tested for COVID-19 since the vaccination. The patient received the first Pfizer dose at 3:20pm. On a consent form, reaction to TDAP vaccine (nausea) and history (hx) of tremors and fibromyalgia were reported. The patient sat for her observation period. After a few minutes, the patient began to look faint. The patient stated lightheadedness, and she was given some water, juice, and some saltine crackers. The patient stated tingling in her arms and fingertips, and weakness-unable to raise the juice box to drink. The patient started to have muscle spasms and uncontrollable jerking movements and convulsions, still coherent, and breathing was not affected. The patient was lowered to the ground, with continued convulsions, worsening spasms, but reported no pain. The patient did not want her albuterol as breathing was okay and was provided 1/4 tablet of Benadryl to no avail. The patient began to state she was tired and began to lose consciousness, closing her eyes. The patient was still shaking when the paramedics came. Treatment for the events included Valium given at the hospital. The events resolved with sequel. The events required Emergency Room Visit and Physician Office Visit.; Sender's Comments: Based on the close temporal relationship, the association between the events syncope and loss of consciousness with BNT162b2 can not be completely 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: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Look faint; lose consciousness; Uncontrollable jerking movements and convulsions; lightheadedness; Tingling in her arms and fingertips; Weakness; Muscle spasms; Uncontrollable jerking movements and convulsions; Tired; Shaking; Shaking; This is a spontaneous report from a contactable pharmacist. A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 05Jun2021 at 15:30 (Batch/Lot Number: EW0180) as 1ST DOSE, SINGLE (at the age of 31-years-old) for COVID-19 immunisation. Medical history included tremors, fibromyalgia, and asthma. The patient had no known drug allergy (NKDA). Reaction to TDAP vaccine (nausea). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if the patient has been tested for COVID-19 since the vaccination. The patient received the first Pfizer dose at 3:20pm. On a consent form, reaction to TDAP vaccine (nausea) and history (hx) of tremors and fibromyalgia were reported. The patient sat for her observation period. After a few minutes, the patient began to look faint. The patient stated lightheadedness, and she was given some water, juice, and some saltine crackers. The patient stated tingling in her arms and fingertips, and weakness-unable to raise the juice box to drink. The patient started to have muscle spasms and uncontrollable jerking movements and convulsions, still coherent, and breathing was not affected. The patient was lowered to the ground, with continued convulsions, worsening spasms, but reported no pain. The patient did not want her albuterol as breathing was okay and was provided 1/4 tablet of Benadryl to no avail. The patient began to state she was tired and began to lose consciousness, closing her eyes. The patient was still shaking when the paramedics came. Treatment for the events included Valium given at the hospital. The events resolved with sequel. The events required Emergency Room Visit and Physician Office Visit.; Sender's Comments: Based on the close temporal relationship, the association between the events syncope and loss of consciousness with BNT162b2 can not be completely 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: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Drooling, Dyschromatopsia, Dysstasia, Fall
Clinical narrative: Second dose given within 2 weeks of first dose
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Fine motor skill dysfunction, Foaming at mouth, Migraine, Movement disorder
Clinical narrative: Second dose given within 2 weeks of first dose
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle spasms, Muscle strain, Seizure, Thinking abnormal, Tremor
Clinical narrative: Second dose given within 2 weeks of first dose
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Walking aid user
Clinical narrative: Second dose given within 2 weeks of first dose
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose given within 2 weeks of first dose
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Malaise
Clinical narrative: Pt had vaccine on 5/26, died (found down, no autopsy yet) on 6/3/21, last seen alive on 6/2/21
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Pt had vaccine on 5/26, died (found down, no autopsy yet) on 6/3/21, last seen alive on 6/2/21
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: ENCEPHALITIS; PURPLE SPOT ON LEG; This spontaneous report received from a patient concerned a male of unspecified age and unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date JUN-2021, the patient had experienced symptoms such as headache, nausea, was completely sick and was diagnosed with encephalitis, patient had encephalitis for over 8 days, had purple spot on leg (Purpura). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from encephalitis on JUN-2021, and the outcome of purple spot on leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210630528-COVID-19 VACCINE AD26.COV2.S -Encephalitis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Nausea, Neck pain, Pyrexia, Rash
Clinical narrative: ENCEPHALITIS; PURPLE SPOT ON LEG; This spontaneous report received from a patient concerned a male of unspecified age and unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date JUN-2021, the patient had experienced symptoms such as headache, nausea, was completely sick and was diagnosed with encephalitis, patient had encephalitis for over 8 days, had purple spot on leg (Purpura). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from encephalitis on JUN-2021, and the outcome of purple spot on leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210630528-COVID-19 VACCINE AD26.COV2.S -Encephalitis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration
Clinical narrative: ENCEPHALITIS; PURPLE SPOT ON LEG; This spontaneous report received from a patient concerned a male of unspecified age and unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date JUN-2021, the patient had experienced symptoms such as headache, nausea, was completely sick and was diagnosed with encephalitis, patient had encephalitis for over 8 days, had purple spot on leg (Purpura). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from encephalitis on JUN-2021, and the outcome of purple spot on leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210630528-COVID-19 VACCINE AD26.COV2.S -Encephalitis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Encephalitis, Purpura
Clinical narrative: ENCEPHALITIS; PURPLE SPOT ON LEG; This spontaneous report received from a patient concerned a male of unspecified age and unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date JUN-2021, the patient had experienced symptoms such as headache, nausea, was completely sick and was diagnosed with encephalitis, patient had encephalitis for over 8 days, had purple spot on leg (Purpura). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from encephalitis on JUN-2021, and the outcome of purple spot on leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210630528-COVID-19 VACCINE AD26.COV2.S -Encephalitis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: POOR QUALITY VACCINE ADMINISTERED; INCORRECT STORAGE OF DRUG; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 15-JUN-2021 13:57 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-JUN-2021, the subject experienced poor quality vaccine administered. On 15-JUN-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and incorrect storage of drug was not reported. This report was non-serious. This case, from the same reporter is linked to 20210635783.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POOR QUALITY VACCINE ADMINISTERED; INCORRECT STORAGE OF DRUG; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 15-JUN-2021 13:57 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-JUN-2021, the subject experienced poor quality vaccine administered. On 15-JUN-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and incorrect storage of drug was not reported. This report was non-serious. This case, from the same reporter is linked to 20210635783.