chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: Patient general Malaise unknown cause . Onsite EMS was called vitals were taken BP 134/84  99% O2 room air HR 80. Patient refused evaluation/care. Left aginst medical advice.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: s/p injection c/o tingling left side of neck, jaw, and below eye. Resolved with no intervention
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Electrocardiogram, Pallor, Syncope
Clinical narrative: Went to sit down and passed out; felt dizzy; nausious/nausia; sweaty; sick feeling; as she was ghost white; bad headache.; This is a spontaneous report from a contactable other Health Professional reported for herself. A 16-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) via intramuscular on left arm on 02Feb2021 03:45 PM, at age of 16 years old at single dose for Covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as allergies to medications, food, or other products was reported as none known. Prior to vaccination, patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included multivitamin and melatonin gummies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via intramuscular at left arm on 12Jan2021 03:45 PM for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported morning after vaccine 03Feb2021 08:00 patient was felt dizzy and nausious. Told her mom and her mom ran over as she was ghost white. Went to sit down and passed out. Patient experienced sweaty, nausia, sick feeling and bad headache. Patient went to the emergency room (ER), they gave fluids and blood work. No heart issues noted. Felt better around 3 hours after. Headache was bad and continued on 05Feb2021 (reported today). Also, still feel nausious and had to lay down. All events occurred on 03Feb2021 08:00 AM. Patient was recovering. It was reported the adverse event result in emergency room/department or urgent care. The seriousness criteria were reported as not serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was received treatment for the adverse event included fluids and heart monitoring. The patient underwent lab tests and procedures which included blood work in Feb2021. Since the vaccination, patient had not been tested for COVID-19. Outcome of events bad headache and nauseous was not recovered, for felt dizzy, as she was ghost white, passed out, sweaty, sick feeling was recovering.; Sender's Comments: Based on the information provided and plausible temporal association, a contributory of the suspect drug to the reported events cannot be completely excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Went to sit down and passed out; felt dizzy; nausious/nausia; sweaty; sick feeling; as she was ghost white; bad headache.; This is a spontaneous report from a contactable other Health Professional reported for herself. A 16-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) via intramuscular on left arm on 02Feb2021 03:45 PM, at age of 16 years old at single dose for Covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as allergies to medications, food, or other products was reported as none known. Prior to vaccination, patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included multivitamin and melatonin gummies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via intramuscular at left arm on 12Jan2021 03:45 PM for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported morning after vaccine 03Feb2021 08:00 patient was felt dizzy and nausious. Told her mom and her mom ran over as she was ghost white. Went to sit down and passed out. Patient experienced sweaty, nausia, sick feeling and bad headache. Patient went to the emergency room (ER), they gave fluids and blood work. No heart issues noted. Felt better around 3 hours after. Headache was bad and continued on 05Feb2021 (reported today). Also, still feel nausious and had to lay down. All events occurred on 03Feb2021 08:00 AM. Patient was recovering. It was reported the adverse event result in emergency room/department or urgent care. The seriousness criteria were reported as not serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was received treatment for the adverse event included fluids and heart monitoring. The patient underwent lab tests and procedures which included blood work in Feb2021. Since the vaccination, patient had not been tested for COVID-19. Outcome of events bad headache and nauseous was not recovered, for felt dizzy, as she was ghost white, passed out, sweaty, sick feeling was recovering.; Sender's Comments: Based on the information provided and plausible temporal association, a contributory of the suspect drug to the reported events cannot be completely excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: Went to sit down and passed out; felt dizzy; nausious/nausia; sweaty; sick feeling; as she was ghost white; bad headache.; This is a spontaneous report from a contactable other Health Professional reported for herself. A 16-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) via intramuscular on left arm on 02Feb2021 03:45 PM, at age of 16 years old at single dose for Covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as allergies to medications, food, or other products was reported as none known. Prior to vaccination, patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included multivitamin and melatonin gummies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via intramuscular at left arm on 12Jan2021 03:45 PM for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported morning after vaccine 03Feb2021 08:00 patient was felt dizzy and nausious. Told her mom and her mom ran over as she was ghost white. Went to sit down and passed out. Patient experienced sweaty, nausia, sick feeling and bad headache. Patient went to the emergency room (ER), they gave fluids and blood work. No heart issues noted. Felt better around 3 hours after. Headache was bad and continued on 05Feb2021 (reported today). Also, still feel nausious and had to lay down. All events occurred on 03Feb2021 08:00 AM. Patient was recovering. It was reported the adverse event result in emergency room/department or urgent care. The seriousness criteria were reported as not serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was received treatment for the adverse event included fluids and heart monitoring. The patient underwent lab tests and procedures which included blood work in Feb2021. Since the vaccination, patient had not been tested for COVID-19. Outcome of events bad headache and nauseous was not recovered, for felt dizzy, as she was ghost white, passed out, sweaty, sick feeling was recovering.; Sender's Comments: Based on the information provided and plausible temporal association, a contributory of the suspect drug to the reported events cannot be completely excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, Pallor
Clinical narrative: Went to sit down and passed out; felt dizzy; nausious/nausia; sweaty; sick feeling; as she was ghost white; bad headache.; This is a spontaneous report from a contactable other Health Professional reported for herself. A 16-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) via intramuscular on left arm on 02Feb2021 03:45 PM, at age of 16 years old at single dose for Covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as allergies to medications, food, or other products was reported as none known. Prior to vaccination, patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included multivitamin and melatonin gummies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via intramuscular at left arm on 12Jan2021 03:45 PM for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported morning after vaccine 03Feb2021 08:00 patient was felt dizzy and nausious. Told her mom and her mom ran over as she was ghost white. Went to sit down and passed out. Patient experienced sweaty, nausia, sick feeling and bad headache. Patient went to the emergency room (ER), they gave fluids and blood work. No heart issues noted. Felt better around 3 hours after. Headache was bad and continued on 05Feb2021 (reported today). Also, still feel nausious and had to lay down. All events occurred on 03Feb2021 08:00 AM. Patient was recovering. It was reported the adverse event result in emergency room/department or urgent care. The seriousness criteria were reported as not serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was received treatment for the adverse event included fluids and heart monitoring. The patient underwent lab tests and procedures which included blood work in Feb2021. Since the vaccination, patient had not been tested for COVID-19. Outcome of events bad headache and nauseous was not recovered, for felt dizzy, as she was ghost white, passed out, sweaty, sick feeling was recovering.; Sender's Comments: Based on the information provided and plausible temporal association, a contributory of the suspect drug to the reported events cannot be completely excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Physical examination, Pruritus
Clinical narrative: Itching all over body. Took Benadryl within the first 15 mins after vaccine.  That wasn?t enough to stop it.  Revived epinephrine, Benadryl and decadron in ER. Had some nausea, but went away; Body and joint aches that have very slowly improved. Got worst on day 5 and 6. Ended in bed and took Advil. And slowly have been improving Headache that started after the itching settled in. Have had on and off with severity. But have not been able to get rid of it 100% yet. And I?m on day 14. Asthma has been easily triggered since vaccine. Needing rescue inhaler more often.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthma, Headache, Nausea, Pain
Clinical narrative: Itching all over body. Took Benadryl within the first 15 mins after vaccine.  That wasn?t enough to stop it.  Revived epinephrine, Benadryl and decadron in ER. Had some nausea, but went away; Body and joint aches that have very slowly improved. Got worst on day 5 and 6. Ended in bed and took Advil. And slowly have been improving Headache that started after the itching settled in. Have had on and off with severity. But have not been able to get rid of it 100% yet. And I?m on day 14. Asthma has been easily triggered since vaccine. Needing rescue inhaler more often.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over body. Took Benadryl within the first 15 mins after vaccine.  That wasn?t enough to stop it.  Revived epinephrine, Benadryl and decadron in ER. Had some nausea, but went away; Body and joint aches that have very slowly improved. Got worst on day 5 and 6. Ended in bed and took Advil. And slowly have been improving Headache that started after the itching settled in. Have had on and off with severity. But have not been able to get rid of it 100% yet. And I?m on day 14. Asthma has been easily triggered since vaccine. Needing rescue inhaler more often.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Flushing
Clinical narrative: Tingling in groin area, tongue, neck, chin and finger right after injection. Went away in about 15 min. 6 hrs later got hot spot burning under my skin in my chest, under my left arm pit to elbow and neck and lower legs. This continues when I get anxious. Like a sunburn just under the skin
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Musculoskeletal discomfort, Paraesthesia, Paraesthesia oral, Skin burning sensation
Clinical narrative: Tingling in groin area, tongue, neck, chin and finger right after injection. Went away in about 15 min. 6 hrs later got hot spot burning under my skin in my chest, under my left arm pit to elbow and neck and lower legs. This continues when I get anxious. Like a sunburn just under the skin
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased, Dizziness, Electrocardiogram, Feeling hot
Clinical narrative: Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in chest; anxiety; nausea with dry heaves; nausea with dry heaves; elevated blood pressure; This is a spontaneous report from a contactable nurse (self-reported). A 70-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; el3249) via an unspecified route of administration, at right arm on 14Jan2021 14:00, at hospital for COVID-19 Immunization. Medical history included HTN (hypertension), GERD (Gastrooesophageal reflux disease), oral cancer 2020 with surgery only, arthritis, hypothryroid and allergies to nickel. Concomitant medications included, irbesartan (AVAPRO), levothyroxine, liothyronine (NP THYROID), lansoprazole (PREVACID), ibuprofen (MOTRIN) and paracetamol (TYLENOL). The patient previously took metoclopramide (REGLAN) and prochlorperazine edisylate (COMPAZINE); patient had allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of medications the patient received within 2 weeks of vaccination, included: avapro, np thyroid, prevacid, motrin, Tylenol. On 14Jan2021 at 14:15 (after 15 minutes of dose), the patient experienced feeling very hot, lips numb and tingly, headache, dizzy, heart beating hard in chest, anxiety, waited another 15 minutes, taken to ER (Emergency Room) on site; elevated blood pressure, nausea with dry heaves. Patient was taken into Emergency room/department for urgent care and received treatment IV solumedrol, ativan and zofran, oral Benadryl. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unknown date in 2021; Sender's Comments: There is a reasonable possibility that the events headache and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT162b2 can not be fully 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: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Nausea, Palpitations, Paraesthesia oral, Retching
Clinical narrative: Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in chest; anxiety; nausea with dry heaves; nausea with dry heaves; elevated blood pressure; This is a spontaneous report from a contactable nurse (self-reported). A 70-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; el3249) via an unspecified route of administration, at right arm on 14Jan2021 14:00, at hospital for COVID-19 Immunization. Medical history included HTN (hypertension), GERD (Gastrooesophageal reflux disease), oral cancer 2020 with surgery only, arthritis, hypothryroid and allergies to nickel. Concomitant medications included, irbesartan (AVAPRO), levothyroxine, liothyronine (NP THYROID), lansoprazole (PREVACID), ibuprofen (MOTRIN) and paracetamol (TYLENOL). The patient previously took metoclopramide (REGLAN) and prochlorperazine edisylate (COMPAZINE); patient had allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of medications the patient received within 2 weeks of vaccination, included: avapro, np thyroid, prevacid, motrin, Tylenol. On 14Jan2021 at 14:15 (after 15 minutes of dose), the patient experienced feeling very hot, lips numb and tingly, headache, dizzy, heart beating hard in chest, anxiety, waited another 15 minutes, taken to ER (Emergency Room) on site; elevated blood pressure, nausea with dry heaves. Patient was taken into Emergency room/department for urgent care and received treatment IV solumedrol, ativan and zofran, oral Benadryl. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unknown date in 2021; Sender's Comments: There is a reasonable possibility that the events headache and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT162b2 can not be fully 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: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased, Dizziness, Feeling hot, Headache
Clinical narrative: Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in chest; anxiety; nausea with dry heaves; nausea with dry heaves; elevated blood pressure; This is a spontaneous report from a contactable nurse (self-reported). A 70-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; el3249) via an unspecified route of administration, at right arm on 14Jan2021 14:00, at hospital for COVID-19 Immunization. Medical history included HTN (hypertension), GERD (Gastrooesophageal reflux disease), oral cancer 2020 with surgery only, arthritis, hypothryroid and allergies to nickel. Concomitant medications included, irbesartan (AVAPRO), levothyroxine, liothyronine (NP THYROID), lansoprazole (PREVACID), ibuprofen (MOTRIN) and paracetamol (TYLENOL). The patient previously took metoclopramide (REGLAN) and prochlorperazine edisylate (COMPAZINE); patient had allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of medications the patient received within 2 weeks of vaccination, included: avapro, np thyroid, prevacid, motrin, Tylenol. On 14Jan2021 at 14:15 (after 15 minutes of dose), the patient experienced feeling very hot, lips numb and tingly, headache, dizzy, heart beating hard in chest, anxiety, waited another 15 minutes, taken to ER (Emergency Room) on site; elevated blood pressure, nausea with dry heaves. Patient was taken into Emergency room/department for urgent care and received treatment IV solumedrol, ativan and zofran, oral Benadryl. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unknown date in 2021; Sender's Comments: There is a reasonable possibility that the events headache and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT162b2 can not be fully 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: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Facial paralysis Bells' Palsy; This is a spontaneous report from two contactable consumers (including patient himself). A 73-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in the left arm on 18Jan2021 11:30 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. He was not diagnosed with COVID prior to vaccination. The patient received other medications in two weeks but had not received other vaccine in four weeks. The patient experienced facial paralysis Bells' Palsy on 03Feb2021 08:00. No treatment was received for the event but the event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered. The patient had not been COVID tested post vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Headache, Injection site pain, Joint swelling, Pain in extremity
Clinical narrative: Adverse reaction:   Erythema Nodosum. She received second Moderna vaccine at approx 11:00AM on 2-5-21,; later that evening/night she developed low grade fever & noticed tender nodules/swollen areas in left arm, then noticed these in right arm, later on in both legs & ankles. Ankles ache when she walks. Initially they were somewhat warm to the touch but not now, still slightly tender to touch. She continued to run a low grade fever 3 days after the second vaccine. She denies having any cold symptoms prior to getting the vaccine; no recent illness. No sore throat, no other rashes, no headaches.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Adverse reaction:   Erythema Nodosum. She received second Moderna vaccine at approx 11:00AM on 2-5-21,; later that evening/night she developed low grade fever & noticed tender nodules/swollen areas in left arm, then noticed these in right arm, later on in both legs & ankles. Ankles ache when she walks. Initially they were somewhat warm to the touch but not now, still slightly tender to touch. She continued to run a low grade fever 3 days after the second vaccine. She denies having any cold symptoms prior to getting the vaccine; no recent illness. No sore throat, no other rashes, no headaches.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Erythema nodosum, Nodule, Pain, Peripheral swelling
Clinical narrative: Adverse reaction:   Erythema Nodosum. She received second Moderna vaccine at approx 11:00AM on 2-5-21,; later that evening/night she developed low grade fever & noticed tender nodules/swollen areas in left arm, then noticed these in right arm, later on in both legs & ankles. Ankles ache when she walks. Initially they were somewhat warm to the touch but not now, still slightly tender to touch. She continued to run a low grade fever 3 days after the second vaccine. She denies having any cold symptoms prior to getting the vaccine; no recent illness. No sore throat, no other rashes, no headaches.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Skin warm
Clinical narrative: Adverse reaction:   Erythema Nodosum. She received second Moderna vaccine at approx 11:00AM on 2-5-21,; later that evening/night she developed low grade fever & noticed tender nodules/swollen areas in left arm, then noticed these in right arm, later on in both legs & ankles. Ankles ache when she walks. Initially they were somewhat warm to the touch but not now, still slightly tender to touch. She continued to run a low grade fever 3 days after the second vaccine. She denies having any cold symptoms prior to getting the vaccine; no recent illness. No sore throat, no other rashes, no headaches.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Rash
Clinical narrative: Patient was vaccinated on 2/3/21 and (3) days later developed rash on abdomen and hip area (trunk) and axilla. She went to MD provider on 2/10/21 and was prescribed zyrtec 10 mg daily
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensitive skin, Urticaria
Clinical narrative: Patient was vaccinated on 2/3/21 and (3) days later developed rash on abdomen and hip area (trunk) and axilla. She went to MD provider on 2/10/21 and was prescribed zyrtec 10 mg daily
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Patient was vaccinated on 2/3/21 and (3) days later developed rash on abdomen and hip area (trunk) and axilla. She went to MD provider on 2/10/21 and was prescribed zyrtec 10 mg daily
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Blood creatine phosphokinase MB, Blood creatine phosphokinase MB increased, Blood creatinine increased, Blood gases abnormal
Clinical narrative: Seizure; AFib; Terrible chills; Muscle pain where every muscle in her body hurt; shaking like crazy and could not stop; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified gender received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. On Sunday night, the patient had to go to ER because she was having terrible chills and was shaking like crazy and could not stop. It lasted 45 minutes. She went to the hospital. They kept her in emergency room. She had AFiB and had a seizure from it. She thought she was dying. After she had this and finally thought it might be a side effect from the injection. She did not know it was in the muscle and she had muscle pain. Thought she was getting beaten by a stick. All evens were in Jan2021. They also called 3 times for her to come back in to get the second dose.  She was sure this was what caused it. Every muscle in her body hurt. At the time she did not know it was injected into the muscle. She did not want to go through this again. She wanted to know if she should get the second dose. Outcome of the event shaking like crazy and could not stop, Terrible chills was recovered on Jan2021. Outcome of the events Muscle pain where every muscle in her body hurt, AFib, Seizure was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urea increased, Brain natriuretic peptide increased, Chest X-ray, Chills, Computerised tomogram head
Clinical narrative: Seizure; AFib; Terrible chills; Muscle pain where every muscle in her body hurt; shaking like crazy and could not stop; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified gender received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. On Sunday night, the patient had to go to ER because she was having terrible chills and was shaking like crazy and could not stop. It lasted 45 minutes. She went to the hospital. They kept her in emergency room. She had AFiB and had a seizure from it. She thought she was dying. After she had this and finally thought it might be a side effect from the injection. She did not know it was in the muscle and she had muscle pain. Thought she was getting beaten by a stick. All evens were in Jan2021. They also called 3 times for her to come back in to get the second dose.  She was sure this was what caused it. Every muscle in her body hurt. At the time she did not know it was injected into the muscle. She did not want to go through this again. She wanted to know if she should get the second dose. Outcome of the event shaking like crazy and could not stop, Terrible chills was recovered on Jan2021. Outcome of the events Muscle pain where every muscle in her body hurt, AFib, Seizure was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Full blood count, Haemoglobin decreased, Headache, Hypercalcaemia
Clinical narrative: Seizure; AFib; Terrible chills; Muscle pain where every muscle in her body hurt; shaking like crazy and could not stop; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified gender received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. On Sunday night, the patient had to go to ER because she was having terrible chills and was shaking like crazy and could not stop. It lasted 45 minutes. She went to the hospital. They kept her in emergency room. She had AFiB and had a seizure from it. She thought she was dying. After she had this and finally thought it might be a side effect from the injection. She did not know it was in the muscle and she had muscle pain. Thought she was getting beaten by a stick. All evens were in Jan2021. They also called 3 times for her to come back in to get the second dose.  She was sure this was what caused it. Every muscle in her body hurt. At the time she did not know it was injected into the muscle. She did not want to go through this again. She wanted to know if she should get the second dose. Outcome of the event shaking like crazy and could not stop, Terrible chills was recovered on Jan2021. Outcome of the events Muscle pain where every muscle in her body hurt, AFib, Seizure was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperglycaemia, Hypotension, Metabolic function test, Pain, Tachycardia
Clinical narrative: Seizure; AFib; Terrible chills; Muscle pain where every muscle in her body hurt; shaking like crazy and could not stop; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified gender received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. On Sunday night, the patient had to go to ER because she was having terrible chills and was shaking like crazy and could not stop. It lasted 45 minutes. She went to the hospital. They kept her in emergency room. She had AFiB and had a seizure from it. She thought she was dying. After she had this and finally thought it might be a side effect from the injection. She did not know it was in the muscle and she had muscle pain. Thought she was getting beaten by a stick. All evens were in Jan2021. They also called 3 times for her to come back in to get the second dose.  She was sure this was what caused it. Every muscle in her body hurt. At the time she did not know it was injected into the muscle. She did not want to go through this again. She wanted to know if she should get the second dose. Outcome of the event shaking like crazy and could not stop, Terrible chills was recovered on Jan2021. Outcome of the events Muscle pain where every muscle in her body hurt, AFib, Seizure was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, White blood cell count increased
Clinical narrative: Seizure; AFib; Terrible chills; Muscle pain where every muscle in her body hurt; shaking like crazy and could not stop; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified gender received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. On Sunday night, the patient had to go to ER because she was having terrible chills and was shaking like crazy and could not stop. It lasted 45 minutes. She went to the hospital. They kept her in emergency room. She had AFiB and had a seizure from it. She thought she was dying. After she had this and finally thought it might be a side effect from the injection. She did not know it was in the muscle and she had muscle pain. Thought she was getting beaten by a stick. All evens were in Jan2021. They also called 3 times for her to come back in to get the second dose.  She was sure this was what caused it. Every muscle in her body hurt. At the time she did not know it was injected into the muscle. She did not want to go through this again. She wanted to know if she should get the second dose. Outcome of the event shaking like crazy and could not stop, Terrible chills was recovered on Jan2021. Outcome of the events Muscle pain where every muscle in her body hurt, AFib, Seizure was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Chills, Myalgia, Seizure, Tremor
Clinical narrative: Seizure; AFib; Terrible chills; Muscle pain where every muscle in her body hurt; shaking like crazy and could not stop; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified gender received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. On Sunday night, the patient had to go to ER because she was having terrible chills and was shaking like crazy and could not stop. It lasted 45 minutes. She went to the hospital. They kept her in emergency room. She had AFiB and had a seizure from it. She thought she was dying. After she had this and finally thought it might be a side effect from the injection. She did not know it was in the muscle and she had muscle pain. Thought she was getting beaten by a stick. All evens were in Jan2021. They also called 3 times for her to come back in to get the second dose.  She was sure this was what caused it. Every muscle in her body hurt. At the time she did not know it was injected into the muscle. She did not want to go through this again. She wanted to know if she should get the second dose. Outcome of the event shaking like crazy and could not stop, Terrible chills was recovered on Jan2021. Outcome of the events Muscle pain where every muscle in her body hurt, AFib, Seizure was unknown.   Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Immediate post-injection reaction, Neuralgia, Pain, Pain in extremity
Clinical narrative: 1.  during the administration, it burned really bad 2.  progressive more pain, (muscle) soreness starting about 10 days after shot--steadily increasing shoulder, trapzius, neck pain/stiffness 3.  after conventional at home treatment for sore muscles for 2 weeks, I saw PA at employee health (25 days after injection) 4.  at the time of visit, (Feb 01) I was in the most pain
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Physiotherapy
Clinical narrative: 1.  during the administration, it burned really bad 2.  progressive more pain, (muscle) soreness starting about 10 days after shot--steadily increasing shoulder, trapzius, neck pain/stiffness 3.  after conventional at home treatment for sore muscles for 2 weeks, I saw PA at employee health (25 days after injection) 4.  at the time of visit, (Feb 01) I was in the most pain
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: 1.  during the administration, it burned really bad 2.  progressive more pain, (muscle) soreness starting about 10 days after shot--steadily increasing shoulder, trapzius, neck pain/stiffness 3.  after conventional at home treatment for sore muscles for 2 weeks, I saw PA at employee health (25 days after injection) 4.  at the time of visit, (Feb 01) I was in the most pain
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Pain, Rotator cuff syndrome, X-ray normal
Clinical narrative: 1.  during the administration, it burned really bad 2.  progressive more pain, (muscle) soreness starting about 10 days after shot--steadily increasing shoulder, trapzius, neck pain/stiffness 3.  after conventional at home treatment for sore muscles for 2 weeks, I saw PA at employee health (25 days after injection) 4.  at the time of visit, (Feb 01) I was in the most pain
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: CHILLS, BODY ACHES, FATIGUE, PAIN AT INJECTION SITE, HEADACHE
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: CHILLS, BODY ACHES, FATIGUE, PAIN AT INJECTION SITE, HEADACHE
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: CHILLS, BODY ACHES, FATIGUE, PAIN AT INJECTION SITE, HEADACHE
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pruritus, Tachycardia
Clinical narrative: Within 5 minutes, she developed itching in the right arm (opposite from injection site), itching on back, redness on the right arm, dyspnea, "out of body experience," "sense of impending doom," chest tightness.  Then, the nurse who observed her transported her to a bed to be evaluated.  stated that she was tachycardic, short of breath and had erythema on both arms. An IV was placed 10 minutes later and 9-1-1 was called.  She was given Pepcid, Benadryl and Solu-Medrol at the clinic before arriving to the emergency room. She was given Epinephrine approximately 1 hour after the reaction occurred as well as IV benadryl. She was sent home with prednisone.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Autoscopy, Chest discomfort, Dyspnoea, Erythema
Clinical narrative: Within 5 minutes, she developed itching in the right arm (opposite from injection site), itching on back, redness on the right arm, dyspnea, "out of body experience," "sense of impending doom," chest tightness.  Then, the nurse who observed her transported her to a bed to be evaluated.  stated that she was tachycardic, short of breath and had erythema on both arms. An IV was placed 10 minutes later and 9-1-1 was called.  She was given Pepcid, Benadryl and Solu-Medrol at the clinic before arriving to the emergency room. She was given Epinephrine approximately 1 hour after the reaction occurred as well as IV benadryl. She was sent home with prednisone.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Tachycardia
Clinical narrative: Within 5 minutes, she developed itching in the right arm (opposite from injection site), itching on back, redness on the right arm, dyspnea, "out of body experience," "sense of impending doom," chest tightness.  Then, the nurse who observed her transported her to a bed to be evaluated.  stated that she was tachycardic, short of breath and had erythema on both arms. An IV was placed 10 minutes later and 9-1-1 was called.  She was given Pepcid, Benadryl and Solu-Medrol at the clinic before arriving to the emergency room. She was given Epinephrine approximately 1 hour after the reaction occurred as well as IV benadryl. She was sent home with prednisone.
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Tongue and throat swelling.
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: Tongue and throat swelling.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dysphagia, Swollen tongue
Clinical narrative: anaphylactic shock 30 minutes after receiving shot  with tongue swelling, air passage swollen shut, and unable to breathe.  received 2 epi pens shots and large shot of Benadryl from paramedics.  I am still having AFTER EFFECTS  1 week later.  Heart still races and blood pressure drops.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Blood pressure decreased, Palpitations, Pharyngeal swelling, Respiratory arrest
Clinical narrative: anaphylactic shock 30 minutes after receiving shot  with tongue swelling, air passage swollen shut, and unable to breathe.  received 2 epi pens shots and large shot of Benadryl from paramedics.  I am still having AFTER EFFECTS  1 week later.  Heart still races and blood pressure drops.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: anaphylactic shock 30 minutes after receiving shot  with tongue swelling, air passage swollen shut, and unable to breathe.  received 2 epi pens shots and large shot of Benadryl from paramedics.  I am still having AFTER EFFECTS  1 week later.  Heart still races and blood pressure drops.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Flushing, Palpitations
Clinical narrative: ten minutes after I got the vaccine they had me sit and wait and  I got a hot flush on my chest and neck. I felt dizzy, light headed. my heart was pounding. nurse came and checked my blood pressure it was 186/86. normal BP is 120-130. she took it again 10 minutes later and it was 170. the whole attack lasted about 25 minutes.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Flushing, Hot flush, Palpitations
Clinical narrative: ten minutes after I got the vaccine they had me sit and wait and  I got a hot flush on my chest and neck. I felt dizzy, light headed. my heart was pounding. nurse came and checked my blood pressure it was 186/86. normal BP is 120-130. she took it again 10 minutes later and it was 170. the whole attack lasted about 25 minutes.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Throat irritation
Clinical narrative: Anaphylaxis and had to go to ED
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis and had to go to ED
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Throat irritation
Clinical narrative: Anaphylaxis and had to go to ED
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Throat irritation
Clinical narrative: Within ~5min of receiving the dose, Pt began experiencing shortness of breath, chest tightness, and a "scratchy throat". Pt reports no other new meds, new/strange foods, or sick contacts. No h/o asthma or anaphylaxis prior to today. Pt's only symptom following her first vaccination dose was localized arm pain. Denies CP, abd pain, N/V/D, or F/C.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Within ~5min of receiving the dose, Pt began experiencing shortness of breath, chest tightness, and a "scratchy throat". Pt reports no other new meds, new/strange foods, or sick contacts. No h/o asthma or anaphylaxis prior to today. Pt's only symptom following her first vaccination dose was localized arm pain. Denies CP, abd pain, N/V/D, or F/C.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Throat irritation
Clinical narrative: Within ~5min of receiving the dose, Pt began experiencing shortness of breath, chest tightness, and a "scratchy throat". Pt reports no other new meds, new/strange foods, or sick contacts. No h/o asthma or anaphylaxis prior to today. Pt's only symptom following her first vaccination dose was localized arm pain. Denies CP, abd pain, N/V/D, or F/C.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Craniocerebral injury, Death, Endotracheal intubation, Fall
Clinical narrative: Exact time of vaccine administration not available, but it is described that this patient collapsed within 1 hour of vaccination on 02/11/2021. The patient's wife states that the patient had slipped and fallen down the stairs when entering their home. She states he was not immediately non-responsive or unconscious after falling/slipping and that he had tried to crawl further into the house. She called 911 and initiated CPR per instruction from the dispatcher.  EMS noted that patient was in v. tach and v. fib and was defibbed multiple times. The patient was non-responsive and had no pulse upon arrival to emergency department. The patient died at the hospital at 16:20 on 02/11/2021 approx. 1 hour after falling. Chief complaint at emergency room presentation  described as cardiac arrest. Physician commented that the patient "possibly suffered traumatic brain injury versus ICH (intracerebral hemorrhage)."