chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Condition aggravated, Dysstasia, Hypoaesthesia, Multiple sclerosis relapse
Clinical narrative: muscle weakness of both legs; exacerbation of the baseline numbness of many areas of my body; This is a spontaneous report from a contactable consumer (patient himself). A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, left arm, on 14Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included multiple sclerosis. Concomitant medication included gabapentin, tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), oxybutynin and vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]). The patient previously took diphenhydramine hydrochloride (BENADRYL) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 18Jan2021 at 11:00, the patient had muscle weakness of both legs to the extent that he could not stand. He had an exacerbation of the baseline numbness of many areas of his body. The event resulted in emergency room/department or urgent care visit and the patient was hospitalized for 2 days. The patient received intravenous antibiotics as treatment. The event was considered serious by the patient, requiring hospitalization. The patient's COVID test post vaccination via nasal swab on 18Jan2021 was negative then via blood test on 20Jan2021 was negative. The patient recovered from the events on an unspecified date.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, SARS-CoV-2 test negative
Clinical narrative: muscle weakness of both legs; exacerbation of the baseline numbness of many areas of my body; This is a spontaneous report from a contactable consumer (patient himself). A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, left arm, on 14Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included multiple sclerosis. Concomitant medication included gabapentin, tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), oxybutynin and vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]). The patient previously took diphenhydramine hydrochloride (BENADRYL) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 18Jan2021 at 11:00, the patient had muscle weakness of both legs to the extent that he could not stand. He had an exacerbation of the baseline numbness of many areas of his body. The event resulted in emergency room/department or urgent care visit and the patient was hospitalized for 2 days. The patient received intravenous antibiotics as treatment. The event was considered serious by the patient, requiring hospitalization. The patient's COVID test post vaccination via nasal swab on 18Jan2021 was negative then via blood test on 20Jan2021 was negative. The patient recovered from the events on an unspecified date.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis, Paraesthesia
Clinical narrative: Belly's palsy, right side of face; This is a spontaneous report from a contactable physician. This physician reported for a 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history included anxiety, cervical myofascial pain syndrome, gastrooesophageal reflux disease (GERD), known allergies: eggs, detergent. The patient's concomitant medications were not reported. The patient previously took salbutamol (ALBUTEROL), diphenhydramine hydrochloride (BENADRYL), esomeprazole (NEXIUM), prochlorperazine (COMPAZINE) and experienced allergies. The patient experienced Belly's palsy, right side of face on 25Jan2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included prednisone and valaciclovir (VALACYCLOVIR). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported Belly's palsy, right side of face and the administration of the COVID-19 vaccine, BNT162B2.   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 RA, IEC, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Blood cholesterol increased, Blood immunoglobulin G normal, Blood immunoglobulin M, Lipids increased
Clinical narrative: Belly's palsy, right side of face; This is a spontaneous report from a contactable physician. This physician reported for a 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history included anxiety, cervical myofascial pain syndrome, gastrooesophageal reflux disease (GERD), known allergies: eggs, detergent. The patient's concomitant medications were not reported. The patient previously took salbutamol (ALBUTEROL), diphenhydramine hydrochloride (BENADRYL), esomeprazole (NEXIUM), prochlorperazine (COMPAZINE) and experienced allergies. The patient experienced Belly's palsy, right side of face on 25Jan2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included prednisone and valaciclovir (VALACYCLOVIR). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported Belly's palsy, right side of face and the administration of the COVID-19 vaccine, BNT162B2.   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 RA, IEC, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Belly's palsy, right side of face; This is a spontaneous report from a contactable physician. This physician reported for a 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history included anxiety, cervical myofascial pain syndrome, gastrooesophageal reflux disease (GERD), known allergies: eggs, detergent. The patient's concomitant medications were not reported. The patient previously took salbutamol (ALBUTEROL), diphenhydramine hydrochloride (BENADRYL), esomeprazole (NEXIUM), prochlorperazine (COMPAZINE) and experienced allergies. The patient experienced Belly's palsy, right side of face on 25Jan2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included prednisone and valaciclovir (VALACYCLOVIR). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported Belly's palsy, right side of face and the administration of the COVID-19 vaccine, BNT162B2.   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 RA, IEC, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Belly's palsy, right side of face; This is a spontaneous report from a contactable physician. This physician reported for a 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history included anxiety, cervical myofascial pain syndrome, gastrooesophageal reflux disease (GERD), known allergies: eggs, detergent. The patient's concomitant medications were not reported. The patient previously took salbutamol (ALBUTEROL), diphenhydramine hydrochloride (BENADRYL), esomeprazole (NEXIUM), prochlorperazine (COMPAZINE) and experienced allergies. The patient experienced Belly's palsy, right side of face on 25Jan2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included prednisone and valaciclovir (VALACYCLOVIR). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported Belly's palsy, right side of face and the administration of the COVID-19 vaccine, BNT162B2.   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 RA, IEC, as appropriate.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hot flush, Paraesthesia, Throat irritation
Clinical narrative: Itching in tongue/mouth/throat, hot flashes, dizziness, sweating, tongue swelling, tachycardia
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hot flush, Hyperhidrosis, Oral pruritus, Swollen tongue
Clinical narrative: Itching in tongue/mouth/throat, hot flashes, dizziness, sweating, tongue swelling, tachycardia
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Throat irritation, Tongue pruritus
Clinical narrative: Itching in tongue/mouth/throat, hot flashes, dizziness, sweating, tongue swelling, tachycardia
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Body temperature increased, Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: The patient was diagnosed with Mononucleosis on 2/1/2021.  Symptoms started on 1/20/2021,  1 day after her second COVID vaccination dose.  Liver enzymes were also elevated
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin decreased, Blood alkaline phosphatase increased, Infectious mononucleosis
Clinical narrative: The patient was diagnosed with Mononucleosis on 2/1/2021.  Symptoms started on 1/20/2021,  1 day after her second COVID vaccination dose.  Liver enzymes were also elevated
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphocyte count increased, Neutrophil count decreased
Clinical narrative: The patient was diagnosed with Mononucleosis on 2/1/2021.  Symptoms started on 1/20/2021,  1 day after her second COVID vaccination dose.  Liver enzymes were also elevated
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased
Clinical narrative: The patient developed ITP and was hospitalized at the Hospital.  If any other questions call.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: The patient developed ITP and was hospitalized at the Hospital.  If any other questions call.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drooling, Fatigue, Headache, Hot flush, Hypoaesthesia
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable Other HCP(patient). A 49-years-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), intramuscular on 05Jan2021 19:00 at the 49 years old at Arm Right at single dose for COVID-19 immunization. The medical history was not reported. The concomitant medications were none. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient experienced Bells Palsy on 20Jan2021 15:00. The event caused Physician Office Visit. The patient received Steroids and viral antibiotic as treatment for the event. There was no COVID prior vaccination. There was no COVID tested post vaccination. There were none known allergies. The outcome of the event was not recovered.  The information on the batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for event Bell's palsy. 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: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Oropharyngeal pain, Paraesthesia, Physical examination
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable Other HCP(patient). A 49-years-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), intramuscular on 05Jan2021 19:00 at the 49 years old at Arm Right at single dose for COVID-19 immunization. The medical history was not reported. The concomitant medications were none. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient experienced Bells Palsy on 20Jan2021 15:00. The event caused Physician Office Visit. The patient received Steroids and viral antibiotic as treatment for the event. There was no COVID prior vaccination. There was no COVID tested post vaccination. There were none known allergies. The outcome of the event was not recovered.  The information on the batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for event Bell's palsy. 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: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable Other HCP(patient). A 49-years-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), intramuscular on 05Jan2021 19:00 at the 49 years old at Arm Right at single dose for COVID-19 immunization. The medical history was not reported. The concomitant medications were none. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient experienced Bells Palsy on 20Jan2021 15:00. The event caused Physician Office Visit. The patient received Steroids and viral antibiotic as treatment for the event. There was no COVID prior vaccination. There was no COVID tested post vaccination. There were none known allergies. The outcome of the event was not recovered.  The information on the batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for event Bell's palsy. 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: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Chest discomfort, Chills, Dizziness, Electrocardiogram
Clinical narrative: The evening of the vaccine, patient experienced typical symptoms, but also fluttering in chest. Two days later patient still had cardiac flutter and presented to the emergency department where she was found to have frequency PVCs and hypokalemia. Patient was instructed to follow up with her cardiologist and reports still having dizziness and chest fluttering on 1/31/21
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Laboratory test, Pyrexia
Clinical narrative: The evening of the vaccine, patient experienced typical symptoms, but also fluttering in chest. Two days later patient still had cardiac flutter and presented to the emergency department where she was found to have frequency PVCs and hypokalemia. Patient was instructed to follow up with her cardiologist and reports still having dizziness and chest fluttering on 1/31/21
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Dizziness, Hypokalaemia, Ventricular extrasystoles
Clinical narrative: The evening of the vaccine, patient experienced typical symptoms, but also fluttering in chest. Two days later patient still had cardiac flutter and presented to the emergency department where she was found to have frequency PVCs and hypokalemia. Patient was instructed to follow up with her cardiologist and reports still having dizziness and chest fluttering on 1/31/21
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Seizure
Clinical narrative: trouble breathing anaphylactic shock turned blue  epi given O2 called EMS transferred to hospital
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Computerised tomogram head, Computerised tomogram thorax, Cyanosis, Dyspnoea
Clinical narrative: trouble breathing anaphylactic shock turned blue  epi given O2 called EMS transferred to hospital
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Laboratory test
Clinical narrative: trouble breathing anaphylactic shock turned blue  epi given O2 called EMS transferred to hospital
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Basal ganglia stroke
Clinical narrative: Basal Ganglia Stroke; This is a spontaneous report from a contactable consumer.  A 95-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 22Jan2021 at 11:15 as a single dose for COVID-19 immunization.  The patient had no relevant medical history or concomitant medications. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jan2021 at 16:00, the patient experienced basal ganglia stroke, which was serious for hospitalization prolongation, disability, and life threatening. The event required a doctor's office visit as well as an emergency room visit (as reported). The patient received the vaccine during existing hospitalization and hospitalization was prolonged due to the event for a total of 4 days. The patient was treated for the event with blood thinners and rehab. On 29Jan2021, the patient had a COVID-19 nasal swab which was negative. The clinical outcome of the basal ganglia stroke was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal relationship, the association between the event basal ganglia stroke with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Basal ganglia stroke, SARS-CoV-2 test negative
Clinical narrative: Basal Ganglia Stroke; This is a spontaneous report from a contactable consumer.  A 95-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 22Jan2021 at 11:15 as a single dose for COVID-19 immunization.  The patient had no relevant medical history or concomitant medications. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jan2021 at 16:00, the patient experienced basal ganglia stroke, which was serious for hospitalization prolongation, disability, and life threatening. The event required a doctor's office visit as well as an emergency room visit (as reported). The patient received the vaccine during existing hospitalization and hospitalization was prolonged due to the event for a total of 4 days. The patient was treated for the event with blood thinners and rehab. On 29Jan2021, the patient had a COVID-19 nasal swab which was negative. The clinical outcome of the basal ganglia stroke was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal relationship, the association between the event basal ganglia stroke with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Chest pain, Dyspnoea, Dyspnoea exertional, Headache
Clinical narrative: accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Imaging procedure abnormal, Myalgia, Pericarditis
Clinical narrative: accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Cardiac imaging procedure abnormal, Cardiovascular evaluation, Chest pain, Dyspnoea
Clinical narrative: accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Myalgia, Pericarditis, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Atrial flutter, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Pain, Pericardial effusion, Pericarditis
Clinical narrative: accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Sleep disorder, Systemic inflammatory response syndrome
Clinical narrative: accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Atrial flutter, Brain natriuretic peptide increased, C-reactive protein increased, Computerised tomogram aorta, Echocardiogram
Clinical narrative: accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit.   Information on the lot/batch number has been requested.