chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tryptase
Clinical narrative: trouble swallowing; Cold metallic taste in back of throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-years-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 25Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included asthma and latex allergy. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient previously took demerol and experienced drug hypersensitivity. The patient experienced cold metallic taste in back of throat and trouble swallowing on 25Jan2021 12:45 with outcome of recovering.  The events resulted in emergency room/department or urgent care visit. The patient received Epi pen injection, Benadryl as treatment and underwent labwork and monitoring. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19  Information on the lot/batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of dysphagia  due to temporal relationship  The clinical presentation, along with the treatment measures, is suggestive of a significant allergic reaction. There is limited information provided in this report.   This case will be reassessed once additional information is available.  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: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Dysphagia, Laboratory test
Clinical narrative: trouble swallowing; Cold metallic taste in back of throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-years-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 25Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included asthma and latex allergy. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient previously took demerol and experienced drug hypersensitivity. The patient experienced cold metallic taste in back of throat and trouble swallowing on 25Jan2021 12:45 with outcome of recovering.  The events resulted in emergency room/department or urgent care visit. The patient received Epi pen injection, Benadryl as treatment and underwent labwork and monitoring. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19  Information on the lot/batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of dysphagia  due to temporal relationship  The clinical presentation, along with the treatment measures, is suggestive of a significant allergic reaction. There is limited information provided in this report.   This case will be reassessed once additional information is available.  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: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Dizziness, Fatigue, Hypotension, Pyrexia
Clinical narrative: Vaccination site muscle pain; fatigue; low-grade fever; breast pain; low blood pressure (92/58); dizziness; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 8982, expiry date: unknown), via an unspecified route of administration in the left arm, on 22Jan2021 20:00, at single dose for COVID-19 immunization, at the hospital. Medical history included allergies to some antibiotics (unspecified), post-traumatic stress disorder (PTSD), anxiety and possible irritable bowel syndrome (IBS). Concomitant medication included fluoxetine and vitamins nos (CVS GUMMY PRENATAL VITAMINS) (pending clarification). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient experienced vaccination site muscle pain, fatigue, low-grade fever, breast pain, low blood pressure (92/58) and dizziness on 23Jan2021 13:00. No treatment was given for the events. The outcome of the events was recovered on an unspecified date. It was reported that breast pain could be related to the patient's period.; Sender's Comments: In agreement with the reporting healthcare professional, the reported breast pain is considered unrelated to the suspect, COVID-19 vaccine, BNT162B2.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site muscle pain; fatigue; low-grade fever; breast pain; low blood pressure (92/58); dizziness; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 8982, expiry date: unknown), via an unspecified route of administration in the left arm, on 22Jan2021 20:00, at single dose for COVID-19 immunization, at the hospital. Medical history included allergies to some antibiotics (unspecified), post-traumatic stress disorder (PTSD), anxiety and possible irritable bowel syndrome (IBS). Concomitant medication included fluoxetine and vitamins nos (CVS GUMMY PRENATAL VITAMINS) (pending clarification). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient experienced vaccination site muscle pain, fatigue, low-grade fever, breast pain, low blood pressure (92/58) and dizziness on 23Jan2021 13:00. No treatment was given for the events. The outcome of the events was recovered on an unspecified date. It was reported that breast pain could be related to the patient's period.; Sender's Comments: In agreement with the reporting healthcare professional, the reported breast pain is considered unrelated to the suspect, COVID-19 vaccine, BNT162B2.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Body temperature, Breast pain, Dizziness, Fatigue
Clinical narrative: Vaccination site muscle pain; fatigue; low-grade fever; breast pain; low blood pressure (92/58); dizziness; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 8982, expiry date: unknown), via an unspecified route of administration in the left arm, on 22Jan2021 20:00, at single dose for COVID-19 immunization, at the hospital. Medical history included allergies to some antibiotics (unspecified), post-traumatic stress disorder (PTSD), anxiety and possible irritable bowel syndrome (IBS). Concomitant medication included fluoxetine and vitamins nos (CVS GUMMY PRENATAL VITAMINS) (pending clarification). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient experienced vaccination site muscle pain, fatigue, low-grade fever, breast pain, low blood pressure (92/58) and dizziness on 23Jan2021 13:00. No treatment was given for the events. The outcome of the events was recovered on an unspecified date. It was reported that breast pain could be related to the patient's period.; Sender's Comments: In agreement with the reporting healthcare professional, the reported breast pain is considered unrelated to the suspect, COVID-19 vaccine, BNT162B2.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Pyrexia, Vaccination site pain
Clinical narrative: Vaccination site muscle pain; fatigue; low-grade fever; breast pain; low blood pressure (92/58); dizziness; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 8982, expiry date: unknown), via an unspecified route of administration in the left arm, on 22Jan2021 20:00, at single dose for COVID-19 immunization, at the hospital. Medical history included allergies to some antibiotics (unspecified), post-traumatic stress disorder (PTSD), anxiety and possible irritable bowel syndrome (IBS). Concomitant medication included fluoxetine and vitamins nos (CVS GUMMY PRENATAL VITAMINS) (pending clarification). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient experienced vaccination site muscle pain, fatigue, low-grade fever, breast pain, low blood pressure (92/58) and dizziness on 23Jan2021 13:00. No treatment was given for the events. The outcome of the events was recovered on an unspecified date. It was reported that breast pain could be related to the patient's period.; Sender's Comments: In agreement with the reporting healthcare professional, the reported breast pain is considered unrelated to the suspect, COVID-19 vaccine, BNT162B2.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: pronounced vestibulocochlear vertigo for over an hour/significantly more pronounced and persistent in duration; This is a spontaneous report from a contactable pharmacist (reported for himself). A 48-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot ELI 283, expiry date not reported), intramuscular on 13Jan2021 11:15 at a single dose in the right arm for COVID-19 immunization. Medical history included patient previously experienced vertigo but never lasting more than a few minutes. The patient had no known allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multivitamins [vitamins nos] (MULTIVITAMINS), resveratrol, melatonin, and turmeric [curcuma longa rhizome]; all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. On 22Jan2021 06:30 AM, the patient experienced pronounced vestibulocochlear vertigo for over an hour. Patient have previously experienced vertigo but never lasting more than a few minutes. This bout was significantly more pronounced and persistent in duration. The event was reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Therapeutic measures were taken as a result of pronounced vestibulocochlear vertigo for over an hour in which the event resolved after patient took a Benadryl and went back to bed for several hours. The event pronounced vestibulocochlear vertigo for over an hour recovered on 22Jan2021 07:30 AM.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Palpitations
Clinical narrative: Afib; Felt dizzy; heart racing; elevated BP; This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration at the right arm on 23Jan2021 at 13:30 (01:30 PM) at single dose for COVID-19 immunization, administered in workplace clinic. The patient is not pregnant. The patient's medical history included atrial fibrillation (Afib), hypertension, thyroid cancer, and lymphoma. It was unknown if the patient has known allergies. Concomitant medications (other medications in two weeks) included multiple prescription medications (unspecified). It was unknown if the patient had other vaccines in four weeks. It was unknown if the patient had COVID prior to vaccination. The patient felt dizzy, heart racing, elevated BP (blood pressure), and Afib on 23Jan2021 at 13:30 (01:30 PM), described as: Felt dizzy and "heart racing", elevated BP (blood pressure) noted with Afib on monitor. Patient felt symptoms at 15 minutes with periods of Afib and normal sinus on the monitor. Vitals and ongoing monitoring taken. The patient verbalized history of chronic Afib. No other symptoms and no distress noted otherwise. The patient and her family declined ER treatment or further medical evaluation. The patient did not receive treatment for the events. It was unknown if the patient was tested for COVID post vaccination. The outcome of the events was recovered on Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Blood pressure increased, Cardiac monitoring abnormal, Condition aggravated, Dizziness
Clinical narrative: Afib; Felt dizzy; heart racing; elevated BP; This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration at the right arm on 23Jan2021 at 13:30 (01:30 PM) at single dose for COVID-19 immunization, administered in workplace clinic. The patient is not pregnant. The patient's medical history included atrial fibrillation (Afib), hypertension, thyroid cancer, and lymphoma. It was unknown if the patient has known allergies. Concomitant medications (other medications in two weeks) included multiple prescription medications (unspecified). It was unknown if the patient had other vaccines in four weeks. It was unknown if the patient had COVID prior to vaccination. The patient felt dizzy, heart racing, elevated BP (blood pressure), and Afib on 23Jan2021 at 13:30 (01:30 PM), described as: Felt dizzy and "heart racing", elevated BP (blood pressure) noted with Afib on monitor. Patient felt symptoms at 15 minutes with periods of Afib and normal sinus on the monitor. Vitals and ongoing monitoring taken. The patient verbalized history of chronic Afib. No other symptoms and no distress noted otherwise. The patient and her family declined ER treatment or further medical evaluation. The patient did not receive treatment for the events. It was unknown if the patient was tested for COVID post vaccination. The outcome of the events was recovered on Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Afib; Felt dizzy; heart racing; elevated BP; This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration at the right arm on 23Jan2021 at 13:30 (01:30 PM) at single dose for COVID-19 immunization, administered in workplace clinic. The patient is not pregnant. The patient's medical history included atrial fibrillation (Afib), hypertension, thyroid cancer, and lymphoma. It was unknown if the patient has known allergies. Concomitant medications (other medications in two weeks) included multiple prescription medications (unspecified). It was unknown if the patient had other vaccines in four weeks. It was unknown if the patient had COVID prior to vaccination. The patient felt dizzy, heart racing, elevated BP (blood pressure), and Afib on 23Jan2021 at 13:30 (01:30 PM), described as: Felt dizzy and "heart racing", elevated BP (blood pressure) noted with Afib on monitor. Patient felt symptoms at 15 minutes with periods of Afib and normal sinus on the monitor. Vitals and ongoing monitoring taken. The patient verbalized history of chronic Afib. No other symptoms and no distress noted otherwise. The patient and her family declined ER treatment or further medical evaluation. The patient did not receive treatment for the events. It was unknown if the patient was tested for COVID post vaccination. The outcome of the events was recovered on Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Limb discomfort
Clinical narrative: Moderna COVID 19 vaccine EUA Patient complaint of having Low grade fever from 98.9 to 102.8. Had body aches, sore arm, "feeling cruddy". "feeling miserable, not feeling myself." Did take Ibuprofen for the symptoms. Had redness/swelling of site, chills, body aches.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling abnormal, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Moderna COVID 19 vaccine EUA Patient complaint of having Low grade fever from 98.9 to 102.8. Had body aches, sore arm, "feeling cruddy". "feeling miserable, not feeling myself." Did take Ibuprofen for the symptoms. Had redness/swelling of site, chills, body aches.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Moderna COVID 19 vaccine EUA Patient complaint of having Low grade fever from 98.9 to 102.8. Had body aches, sore arm, "feeling cruddy". "feeling miserable, not feeling myself." Did take Ibuprofen for the symptoms. Had redness/swelling of site, chills, body aches.
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: Lymphedema 1/24 elevation time is 16 s. 2-8 added compression  one lasix elevation
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphoedema
Clinical narrative: Lymphedema 1/24 elevation time is 16 s. 2-8 added compression  one lasix elevation
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Hypoaesthesia
Clinical narrative: numbness in hands and feet; slight shortness of breath; This is a spontaneous report from a contactable nurse. A 32-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL3248; expiration date: unknown), intramuscular left arm on 26Jan2021 12:15 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took morphine and acetaminophen but had allergies. The patient did not receive other vaccine in four weeks. The patient received the vaccine in a public health clinic/veterans administration facility. The patient reported that she received vaccine and was waiting in the observation area. She complained of numbness in hands and feet and slight shortness of breath on 26Jan2021 12:30 PM. She was offered and ingested diphenhydramine 25 mg at 12:30 and another 25mg at 12:38. Patient's radial pulse was strong and regular. On examination, there was no rash, no swelling visible, no respiratory stridor and the patient was able to talk in complete sentence with one breath. The patient continued to feel symptoms (not better and not worse) so 911 ambulance was called. The patient's care was turned over to them when they arrived. It was mentioned that the patient received treatment that included diphenhydramine and ambulance to ETC. The adverse events resulted in emergency room/department or urgent care. It was unknown if the patient was with COVID prior vaccination and if the patient was COVID tested post vaccination. The outcome of the events was not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate, Hypoaesthesia, Physical examination
Clinical narrative: numbness in hands and feet; slight shortness of breath; This is a spontaneous report from a contactable nurse. A 32-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL3248; expiration date: unknown), intramuscular left arm on 26Jan2021 12:15 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took morphine and acetaminophen but had allergies. The patient did not receive other vaccine in four weeks. The patient received the vaccine in a public health clinic/veterans administration facility. The patient reported that she received vaccine and was waiting in the observation area. She complained of numbness in hands and feet and slight shortness of breath on 26Jan2021 12:30 PM. She was offered and ingested diphenhydramine 25 mg at 12:30 and another 25mg at 12:38. Patient's radial pulse was strong and regular. On examination, there was no rash, no swelling visible, no respiratory stridor and the patient was able to talk in complete sentence with one breath. The patient continued to feel symptoms (not better and not worse) so 911 ambulance was called. The patient's care was turned over to them when they arrived. It was mentioned that the patient received treatment that included diphenhydramine and ambulance to ETC. The adverse events resulted in emergency room/department or urgent care. It was unknown if the patient was with COVID prior vaccination and if the patient was COVID tested post vaccination. The outcome of the events was not recovered.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthenia, Erythema, Flushing, Hyperhidrosis
Clinical narrative: He states he received the vaccine and within 2-3 minutes he experienced dizziness, chest tightness affecting breathing, tunnel vision, disorientation. He asked for help and first they walked him to a chair and then laid him down. He recalls the MD taking his pulse and reporting it as 140. He states his awareness was blurred, but he remembers receiving the epi pen and then feeling better. He recalls sweating but not sure if it was before or after epinephrine. EMS arrived, started an IV and transported him to ER. He denies recalling pruritis, urticaria, oral face throat or tongue swelling, watery eyes, chest pain, cough, wheeze, nausea or emesis. ER observed him several hours. His discharge diagnosis was syncope. He denies recent use of antihistamines or H2 blockers. Per chart review, provider at the event recorded patient c/o hot dizzy, tachycardia, erythema bilat arms, chest with extension to the neck, diaphoresis, difficulty responding (single word only); treated with epinephrine with improved response.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: He states he received the vaccine and within 2-3 minutes he experienced dizziness, chest tightness affecting breathing, tunnel vision, disorientation. He asked for help and first they walked him to a chair and then laid him down. He recalls the MD taking his pulse and reporting it as 140. He states his awareness was blurred, but he remembers receiving the epi pen and then feeling better. He recalls sweating but not sure if it was before or after epinephrine. EMS arrived, started an IV and transported him to ER. He denies recalling pruritis, urticaria, oral face throat or tongue swelling, watery eyes, chest pain, cough, wheeze, nausea or emesis. ER observed him several hours. His discharge diagnosis was syncope. He denies recent use of antihistamines or H2 blockers. Per chart review, provider at the event recorded patient c/o hot dizzy, tachycardia, erythema bilat arms, chest with extension to the neck, diaphoresis, difficulty responding (single word only); treated with epinephrine with improved response.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Altered state of consciousness, Chest discomfort, Disorientation, Dizziness, Erythema
Clinical narrative: He states he received the vaccine and within 2-3 minutes he experienced dizziness, chest tightness affecting breathing, tunnel vision, disorientation. He asked for help and first they walked him to a chair and then laid him down. He recalls the MD taking his pulse and reporting it as 140. He states his awareness was blurred, but he remembers receiving the epi pen and then feeling better. He recalls sweating but not sure if it was before or after epinephrine. EMS arrived, started an IV and transported him to ER. He denies recalling pruritis, urticaria, oral face throat or tongue swelling, watery eyes, chest pain, cough, wheeze, nausea or emesis. ER observed him several hours. His discharge diagnosis was syncope. He denies recent use of antihistamines or H2 blockers. Per chart review, provider at the event recorded patient c/o hot dizzy, tachycardia, erythema bilat arms, chest with extension to the neck, diaphoresis, difficulty responding (single word only); treated with epinephrine with improved response.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Respiration abnormal, Skin warm, Speech disorder, Syncope
Clinical narrative: He states he received the vaccine and within 2-3 minutes he experienced dizziness, chest tightness affecting breathing, tunnel vision, disorientation. He asked for help and first they walked him to a chair and then laid him down. He recalls the MD taking his pulse and reporting it as 140. He states his awareness was blurred, but he remembers receiving the epi pen and then feeling better. He recalls sweating but not sure if it was before or after epinephrine. EMS arrived, started an IV and transported him to ER. He denies recalling pruritis, urticaria, oral face throat or tongue swelling, watery eyes, chest pain, cough, wheeze, nausea or emesis. ER observed him several hours. His discharge diagnosis was syncope. He denies recent use of antihistamines or H2 blockers. Per chart review, provider at the event recorded patient c/o hot dizzy, tachycardia, erythema bilat arms, chest with extension to the neck, diaphoresis, difficulty responding (single word only); treated with epinephrine with improved response.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Tunnel vision
Clinical narrative: He states he received the vaccine and within 2-3 minutes he experienced dizziness, chest tightness affecting breathing, tunnel vision, disorientation. He asked for help and first they walked him to a chair and then laid him down. He recalls the MD taking his pulse and reporting it as 140. He states his awareness was blurred, but he remembers receiving the epi pen and then feeling better. He recalls sweating but not sure if it was before or after epinephrine. EMS arrived, started an IV and transported him to ER. He denies recalling pruritis, urticaria, oral face throat or tongue swelling, watery eyes, chest pain, cough, wheeze, nausea or emesis. ER observed him several hours. His discharge diagnosis was syncope. He denies recent use of antihistamines or H2 blockers. Per chart review, provider at the event recorded patient c/o hot dizzy, tachycardia, erythema bilat arms, chest with extension to the neck, diaphoresis, difficulty responding (single word only); treated with epinephrine with improved response.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Vaccination site pain
Clinical narrative: Severe pain in upper left arm muscle (vaccine site); Severe pain in upper left arm muscle (vaccine site)/ also in my left shoulder joint; Severe pain in upper left arm muscle (vaccine site)/ also in my left shoulder joint/ unable to lift my left arm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 13Jan2021 12:45 at single dose for COVID-19 immunization. Medical history included high blood pressure and cholesterol from an unknown date and unknown if ongoing. Concomitant medication included medication for high blood pressure and cholesterol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that initially, there was no adverse reaction, but 10 days later on 24Jan2021 07:00 AM, the patient stated, "I experienced severe pain in upper left arm muscle (vaccine site) and also in my left shoulder joint. Also unable to lift my left arm. The lower arm and fingers function normally. These symptoms continue through today 12 days after the vaccine ". The outcome of the events was not recovered. No treatment was given to the patient for the events. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and were not a congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site joint movement impairment, Vaccination site joint pain, Vaccination site pain
Clinical narrative: Severe pain in upper left arm muscle (vaccine site); Severe pain in upper left arm muscle (vaccine site)/ also in my left shoulder joint; Severe pain in upper left arm muscle (vaccine site)/ also in my left shoulder joint/ unable to lift my left arm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 13Jan2021 12:45 at single dose for COVID-19 immunization. Medical history included high blood pressure and cholesterol from an unknown date and unknown if ongoing. Concomitant medication included medication for high blood pressure and cholesterol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that initially, there was no adverse reaction, but 10 days later on 24Jan2021 07:00 AM, the patient stated, "I experienced severe pain in upper left arm muscle (vaccine site) and also in my left shoulder joint. Also unable to lift my left arm. The lower arm and fingers function normally. These symptoms continue through today 12 days after the vaccine ". The outcome of the events was not recovered. No treatment was given to the patient for the events. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and were not a congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Feeling hot, Headache
Clinical narrative: Fatigue for 12 days; severe pain to all joints especially knees and neck; severe pain to all joints especially knees and neck; weakness; nausea; headache; feverish; swelling of left arm; malaise for 12 days; symptoms of pain lasted 12 days-I still don't feel 100%; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: e1 3246), via an unspecified route of administration at the left arm on 11Jan2021 at single dose for COVID-19 immunization. The vaccine was received in a nursing home. Medical history included seasonal allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 11Jan2021 04:00 PM, the patient experienced fatigue for 12 days, severe pain to all joints especially knees and neck, weakness, nausea, headache, feverish, swelling of left arm, malaise for 12 days, symptoms of pain lasted 12 days- I still don't feel 100%.The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. Events resulted to Doctor or other healthcare professional office/clinic visit. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 using Nasal Swab on 22Jan2021 and result was negative. The outcome of the events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Fatigue for 12 days; severe pain to all joints especially knees and neck; severe pain to all joints especially knees and neck; weakness; nausea; headache; feverish; swelling of left arm; malaise for 12 days; symptoms of pain lasted 12 days-I still don't feel 100%; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: e1 3246), via an unspecified route of administration at the left arm on 11Jan2021 at single dose for COVID-19 immunization. The vaccine was received in a nursing home. Medical history included seasonal allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 11Jan2021 04:00 PM, the patient experienced fatigue for 12 days, severe pain to all joints especially knees and neck, weakness, nausea, headache, feverish, swelling of left arm, malaise for 12 days, symptoms of pain lasted 12 days- I still don't feel 100%.The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. Events resulted to Doctor or other healthcare professional office/clinic visit. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 using Nasal Swab on 22Jan2021 and result was negative. The outcome of the events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Malaise
Clinical narrative: Fatigue for 12 days; severe pain to all joints especially knees and neck; severe pain to all joints especially knees and neck; weakness; nausea; headache; feverish; swelling of left arm; malaise for 12 days; symptoms of pain lasted 12 days-I still don't feel 100%; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: e1 3246), via an unspecified route of administration at the left arm on 11Jan2021 at single dose for COVID-19 immunization. The vaccine was received in a nursing home. Medical history included seasonal allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 11Jan2021 04:00 PM, the patient experienced fatigue for 12 days, severe pain to all joints especially knees and neck, weakness, nausea, headache, feverish, swelling of left arm, malaise for 12 days, symptoms of pain lasted 12 days- I still don't feel 100%.The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. Events resulted to Doctor or other healthcare professional office/clinic visit. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 using Nasal Swab on 22Jan2021 and result was negative. The outcome of the events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neck pain, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fatigue for 12 days; severe pain to all joints especially knees and neck; severe pain to all joints especially knees and neck; weakness; nausea; headache; feverish; swelling of left arm; malaise for 12 days; symptoms of pain lasted 12 days-I still don't feel 100%; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: e1 3246), via an unspecified route of administration at the left arm on 11Jan2021 at single dose for COVID-19 immunization. The vaccine was received in a nursing home. Medical history included seasonal allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 11Jan2021 04:00 PM, the patient experienced fatigue for 12 days, severe pain to all joints especially knees and neck, weakness, nausea, headache, feverish, swelling of left arm, malaise for 12 days, symptoms of pain lasted 12 days- I still don't feel 100%.The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. Events resulted to Doctor or other healthcare professional office/clinic visit. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 using Nasal Swab on 22Jan2021 and result was negative. The outcome of the events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fatigue for 12 days; severe pain to all joints especially knees and neck; severe pain to all joints especially knees and neck; weakness; nausea; headache; feverish; swelling of left arm; malaise for 12 days; symptoms of pain lasted 12 days-I still don't feel 100%; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: e1 3246), via an unspecified route of administration at the left arm on 11Jan2021 at single dose for COVID-19 immunization. The vaccine was received in a nursing home. Medical history included seasonal allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 11Jan2021 04:00 PM, the patient experienced fatigue for 12 days, severe pain to all joints especially knees and neck, weakness, nausea, headache, feverish, swelling of left arm, malaise for 12 days, symptoms of pain lasted 12 days- I still don't feel 100%.The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. Events resulted to Doctor or other healthcare professional office/clinic visit. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 using Nasal Swab on 22Jan2021 and result was negative. The outcome of the events was recovering.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Peripheral coldness, Rash
Clinical narrative: dizziness; cold extremities; redness in left ear; rash on left shoulder; Mild anxiety; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3302), intramuscular at the left arm on 26Jan2021 11:00 at a single dose for covid-19 immunization. The vaccine was administered in a hospital.  The patient's medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. Historical vaccine includes first dose of bnt162b2 on 05Jan2021 10:15 AM, lot number: EL1284, intramuscular at the left arm for COVID-19 immunization at the age of 26 years. No reaction to first dose was reported. On 26Jan2021 11:00, the patient experienced dizziness, cold extremities, redness in left ear and rash on left shoulder noted and mild anxiety. Oral 25 mg Benadryl was administered. Returned to work at 10:25 am. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on 26Jan2021.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Erythema, Peripheral coldness, Rash
Clinical narrative: dizziness; cold extremities; redness in left ear; rash on left shoulder; Mild anxiety; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3302), intramuscular at the left arm on 26Jan2021 11:00 at a single dose for covid-19 immunization. The vaccine was administered in a hospital.  The patient's medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. Historical vaccine includes first dose of bnt162b2 on 05Jan2021 10:15 AM, lot number: EL1284, intramuscular at the left arm for COVID-19 immunization at the age of 26 years. No reaction to first dose was reported. On 26Jan2021 11:00, the patient experienced dizziness, cold extremities, redness in left ear and rash on left shoulder noted and mild anxiety. Oral 25 mg Benadryl was administered. Returned to work at 10:25 am. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on 26Jan2021.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: When got up I passed out; blood pressure shoot up to 180 over 100; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient took the covid dose yesterday and after he/she took it, he/she sat there for few minutes and then when he/she got up he/she just passed out. The patient mentioned that they called the code blue in the hospital, they tried to, they were going to, he/she doesn't know what they were going to do but they ended up taking the patient to the emergency room where they ran every test possible blood work they did chest X-ray, they did EKG. The patient stated that the only thing that was consistent was that after the vaccine his/her blood pressure shot up to 180 over 100 and they were trying to get it down, they gave the patient some fluid (unspecified) which stayed for over two hours. The patient added that he/she have never had any blood pressure issues, as he/she was not even on any medications. The patient mentioned that he/she was now afraid to take the second dose. The events occurred on 27Jan2021 with outcome of unknown. Unknown results for blood work, EKG and chest X-ray. The reporter considered the events serious per hospitalization on 27Jan2021.   Information on the lot/ batch number has been requested.