chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic, Urticaria
Clinical narrative: Had an overall body rash; An overall rash with some small welt; very itchy started on my face with burning and itching; An overall rash with some small welt; it was an overall rash with some small welt, very itchy started on my face with burning and itching and then was all over to my body; This is a spontaneous report from a contactable nurse (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: 30155BA), via an unspecified route of administration, administered in Arm Right on 28Sep2021 (at the age of 75-year-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included Atrial fibrillation. Concomitant medication(s) included apixaban (ELIQUIS) taken for atrial fibrillation (for blood clotting), start and stop date were not reported. The patient did not receive any other vaccination 4 weeks prior to COVID 19 Vaccine. The patient had booster shot actually on 28Sep2021 which had been, that was Wednesday. The patient wanted to report a symptom she had after having the booster shot for COVID. This morning (03Oct2021) which would be approximately four days after having the booster on Wednesday, 28Sep2021. he patient had an overall body rash which last persisted for between one to two hours and then disappeared, she had, it was an overall rash with some small welt, very itchy started on her face with burning and itching and then was all over to her body. It was reported that after 1 to 2 hours rash disappeared, she meant it was there for hour and a half to two hours, probably two hour. Stated, that's no longer a problem. That had improved, it's gone away, the rash was gone away. The patient did not receive any treatment for the rash. When asked for causality, the patient stated, she had no idea she had no way of knowing that, she was just reporting what happened, she did not know if it was related to, she just since she have had the booster she was told to report any adverse thing. It's been far enough away from the booster that she wouldn't know if that was (voice not clear) but stated who knows and she don't know. The patient had not undergone lab test in the last two weeks. Outcome of the events was recovered on 03Oct2021.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Capillary leak syndrome
Clinical narrative: I have seen 2 patients with symptoms partially resembling systemic capillary leak syndrome after Pfizer Covid vaccination; This is a spontaneous report from a contactable physician. This Physician reported similar events for 2 patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter had seen 2 patients with symptoms partially resembling systemic capillary leak syndrome after Pfizer Covid vaccination on an unspecified date with outcome of unknown.  The most recent, reporter was considering trying to get IVIG treatment. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal association between the event capillary leak syndrome and suspect drug BNT162B2 cannot be 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.,Linked Report(s) : US-PFIZER INC-202101324931 same product, reporter and event, different patients.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis noninfective, Immunisation, Off label use, Pain
Clinical narrative: Appendicitis noninfective  / Serositis of the Appendix; Lot of pain; Dose 3 was administered on 19Aug2021; Dose 3 was administered on 19Aug2021; This is a solicited report based on information received by Pfizer from AbbVie (Manufacturer Control Number 21K-163-4104056-00) via a contactable consumer (patient).     A 51-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 19Aug2021 (Batch/Lot number was not reported) (at the age of 51 years old) as dose 3 (booster), single dose for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe hidradenitis suppurativa, and moderate to severe rheumatoid arthritis. The patient medical history was not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 via intramuscular (at the age of 50 years old), and the second dose on 28Apr2021 via intramuscular (at the age of 50 years old), for Covid-19 immunization. The patient's concomitant medications were not reported. The patient previously took codeine, levaquin, and amoxicillin and experienced allergy. The patient experienced appendicitis noninfective/serositis of the appendix on an unspecified date. The patient had an emergency appendectomy for serositis of the appendix. The patient had a lot of pain on 19Aug2021. The action taken in response to the events for adalimumab was unknown. Outcome of the events was unknown.  Sender Comment: AbbVie's opinion is that there is no reasonable possibility that the events of Serositis of the Appendix and after receiving third Covid shot had lot of pain are related to HUMIRA (ADALIMUMAB).  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events appendicitis, pain, off label use and booster dose and the suspect drug BNT162B2 cannot be 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient). A 72-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EM9809), dose 2 via an unspecified route of administration, administered in arm left on 12Feb2021 09:45 (at the age of 72-year-old) as single dose for covid-19 immunisation. Medical history included high blood pressure (HBP), high cholesterol, macular degeneration, osteopenia, allergy to sulfa antibiotics, Latex, IVP dye. Concomitant medications included losartan; simvastatin; vitamin D nos; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION). No other vaccines administered in four weeks. The patient previously took first dose of bnt162b2 (Lot number: EL9261) in arm left on 22Jan2021 10:00 for covid-19 immunisation and experienced mild itching, clarithromycin (Macrobid) and experienced allergy. After second dose, on an unspecified date of Feb2021, the patient experienced major flare up of eczema that had not been an issue since she was a child. Tinnitus began in right ear that had never been a problem. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment of events included Prednisone Dosepak, Steroid Cream. The outcome of events was not recovered. Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Hyperhidrosis, Migraine
Clinical narrative: Migraine; nausea; dizziness; hot cold sweats; bad calf pain; chest pain; chest pressure; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 02Oct2021 10:15 (Lot Number: Ff8839) as single dose for covid-19 immunisation at the age of 38-year-old.  Medical history included anaemia and known allergies: acetylsalicylic acid (ASPIRIN), codeine, shellfish. Patient had no covid prior vaccination. Concomitant medication included ferrous sulfate (IRON). No other vaccine in four weeks were taken. The patient experienced migraine, nausea, dizziness, hot cold sweats, bad calf pain, chest pain, chest pressure on 02Oct2021 15:00 PM. These events resulted in emergency room/department or urgent care and hospitalization. Patient was in hospitalization for 2 days. Th patient received treatment Ativan, Zofran, IV for events. Patient had tested covid post vaccination. The patient underwent lab tests and procedures which included rapid test (nasal swab): negative on 04Oct2021. Outcome of events was resolved with sequel in Oct2021.   Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Migraine; nausea; dizziness; hot cold sweats; bad calf pain; chest pain; chest pressure; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 02Oct2021 10:15 (Lot Number: Ff8839) as single dose for covid-19 immunisation at the age of 38-year-old.  Medical history included anaemia and known allergies: acetylsalicylic acid (ASPIRIN), codeine, shellfish. Patient had no covid prior vaccination. Concomitant medication included ferrous sulfate (IRON). No other vaccine in four weeks were taken. The patient experienced migraine, nausea, dizziness, hot cold sweats, bad calf pain, chest pain, chest pressure on 02Oct2021 15:00 PM. These events resulted in emergency room/department or urgent care and hospitalization. Patient was in hospitalization for 2 days. Th patient received treatment Ativan, Zofran, IV for events. Patient had tested covid post vaccination. The patient underwent lab tests and procedures which included rapid test (nasal swab): negative on 04Oct2021. Outcome of events was resolved with sequel in Oct2021.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rhinitis allergic
Clinical narrative: Allergic rhinitis, extremely sever.; This is a spontaneous report from a contactable other hcp (patient).  A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Ew0175) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included known allergies: pollen and no other medical history. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 04Aug2021 at 15:00 (Batch/Lot Number: Ew0175) as DOSE 1, SINGLE for covid-19 immunisation. There is no other vaccine in four weeks. There were no concomitant medications.  The patient experienced allergic rhinitis, extremely sever (medically significant) on 01Sep2021. The outcome of event was not recovered without treatment received.   The patient had no covid prior vaccination and had no covid test post vaccination.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Rhinitis allergic and 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: blood clot in between muscles; huge pain in his left leg (same side where he got the vaccine shot); This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 51 years (as reported) on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 for Covid-19 immunization. 10 days after getting the second dose of the Pfizer BioNtech Covid-19 Vaccine, patient felt a huge pain in his left leg for a week (same side where he got the vaccine shot) and when he went to the doctor, he was told that he had a blood clot in between his muscles. Patient was about to have his booster dose by tomorrow and was concerned if it would be a contraindication for him. Patient wanted to know if the blood clot and leg pain that he experienced after getting the second shot of the Pfizer BioNtech Covid-19 vaccine would be a contraindication for his booster shot tomorrow. Seriousness was reported as no. The outcome of the event Leg pain was recovered with duration of 7 days, other event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program. This consumer reported similar events for six patients. This is the first of six reports. This patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient developed GBS (Guillain-Barre syndrome) after getting the vaccine. The reporting consumer wanted to know if there were reports of GBS and also wanted to know if she could speak to someone about GBS reports. The reporting consumer mentioned that she knew 6 people who developed GBS after getting the vaccine. Outcome of the event was unknown. This report was assessed by the reporting consumer as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101334155 same reporter/drug/event, different patients;US-PFIZER INC-202101334154 same reporter/drug/event, different patients;US-PFIZER INC-202101334158 same reporter/drug/event, different patients;US-PFIZER INC-202101334157 same reporter/drug/event, different patients;US-PFIZER INC-202101334156 same reporter/drug/event, different patients
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he was diagnosed with Covid-19 infection three weeks after receiving his first dose/contracted the Covid virus; he was diagnosed with Covid-19 infection three weeks after receiving his first dose/contracted the Covid virus; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in 2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In 2021, the patient was diagnosed with COVID-19 infection three weeks after receiving his first dose of the Pfizer BioNTech Covid-19 Vaccine. The COVID kept him down for about three and a half weeks with high fevers coming and going. He contracted the COVID virus and was sick for a month. The outcome of the events was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Blood test, Computerised tomogram, Dizziness
Clinical narrative: Blood pressure was abnormally high 169 over 103.3; was feeling weak; very tired; legs weak/legs went out from under me; having heart palpitations; fast heartbeat in chest up to throat; face would turn red; night sweats; restless legs; light temple headaches; short of breath; pain in hands,wrist; very cold feet; gas; burping; EKG which showed abnormal problems which included inferior infarction; complained of large left toe had been hurting me for quite a while and would wake me up during night hurting; Went to E.R. because of dizziness that was very extreme; Was diagnosed with vertigo; This is a spontaneous report from a contactable consumer(patient). A 71-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 27Mar2021 14:30, at 71-year-old, as single dose (Lot Number: ER8727) for covid-19 immunisation. Medical history included pre diabetic, high cholesterol, thyroid and acid reflux. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 27Feb2021 14:30, at 71-year-old, as single dose (Lot Number: EN6198) for covid-19 immunisation. The patient had other medications in two weeks(not reported).  No other vaccine in four weeks. The patient had not got covid prior vaccination and had no covid tested post vaccination. No Known allergies. On Apr2021, the patient complained of large left toe had been hurting her for quite a while and would wake her up during night hurting. She got different opinions of what it may be. On 28May2021, the patient went to Urgent Care Clinic for painful toe since middle of night and blood pressure was abnormally high 169 over 103. On 03Jun2021, the patient had healthcare professional office visit for the high blood pressure and was feeling weak, very tired, legs weak, having heart palpitations, fast heartbeat in chest up to throat. The patient had these symptoms from May2021 to Jul2021. She couldn't walk very far because of weakness. On an unspecified date in 2021, patient went to emergency room because of dizziness that was very extreme. She was diagnosed with vertigo. Blood pressure was still very high. The patient had computerised tomogram (CT), bloodwork, electrocardiogram (EKG) which showed abnormal problems which included inferior infarction on 26Apr2021.  Other symptoms of something going on during May2021 to Aug2021, included: face would turn red, legs went out from under her, night sweats, restless legs, light temple headaches, short of breath, pain in hands, wrists, very cold feet, gas, burping. All of this happened to the patient out of the blue. Therapeutic measures were taken as a result of all events included: New blood pressure medicines, CT scans, blood works and 3 EKGs. The outcome of all events was recovered with lasting effects. The case was serious due to medically significant condition.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Eructation, Erythema, Fatigue
Clinical narrative: Blood pressure was abnormally high 169 over 103.3; was feeling weak; very tired; legs weak/legs went out from under me; having heart palpitations; fast heartbeat in chest up to throat; face would turn red; night sweats; restless legs; light temple headaches; short of breath; pain in hands,wrist; very cold feet; gas; burping; EKG which showed abnormal problems which included inferior infarction; complained of large left toe had been hurting me for quite a while and would wake me up during night hurting; Went to E.R. because of dizziness that was very extreme; Was diagnosed with vertigo; This is a spontaneous report from a contactable consumer(patient). A 71-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 27Mar2021 14:30, at 71-year-old, as single dose (Lot Number: ER8727) for covid-19 immunisation. Medical history included pre diabetic, high cholesterol, thyroid and acid reflux. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 27Feb2021 14:30, at 71-year-old, as single dose (Lot Number: EN6198) for covid-19 immunisation. The patient had other medications in two weeks(not reported).  No other vaccine in four weeks. The patient had not got covid prior vaccination and had no covid tested post vaccination. No Known allergies. On Apr2021, the patient complained of large left toe had been hurting her for quite a while and would wake her up during night hurting. She got different opinions of what it may be. On 28May2021, the patient went to Urgent Care Clinic for painful toe since middle of night and blood pressure was abnormally high 169 over 103. On 03Jun2021, the patient had healthcare professional office visit for the high blood pressure and was feeling weak, very tired, legs weak, having heart palpitations, fast heartbeat in chest up to throat. The patient had these symptoms from May2021 to Jul2021. She couldn't walk very far because of weakness. On an unspecified date in 2021, patient went to emergency room because of dizziness that was very extreme. She was diagnosed with vertigo. Blood pressure was still very high. The patient had computerised tomogram (CT), bloodwork, electrocardiogram (EKG) which showed abnormal problems which included inferior infarction on 26Apr2021.  Other symptoms of something going on during May2021 to Aug2021, included: face would turn red, legs went out from under her, night sweats, restless legs, light temple headaches, short of breath, pain in hands, wrists, very cold feet, gas, burping. All of this happened to the patient out of the blue. Therapeutic measures were taken as a result of all events included: New blood pressure medicines, CT scans, blood works and 3 EKGs. The outcome of all events was recovered with lasting effects. The case was serious due to medically significant condition.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Headache, Heart rate increased, Hypertension, Infarction
Clinical narrative: Blood pressure was abnormally high 169 over 103.3; was feeling weak; very tired; legs weak/legs went out from under me; having heart palpitations; fast heartbeat in chest up to throat; face would turn red; night sweats; restless legs; light temple headaches; short of breath; pain in hands,wrist; very cold feet; gas; burping; EKG which showed abnormal problems which included inferior infarction; complained of large left toe had been hurting me for quite a while and would wake me up during night hurting; Went to E.R. because of dizziness that was very extreme; Was diagnosed with vertigo; This is a spontaneous report from a contactable consumer(patient). A 71-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 27Mar2021 14:30, at 71-year-old, as single dose (Lot Number: ER8727) for covid-19 immunisation. Medical history included pre diabetic, high cholesterol, thyroid and acid reflux. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 27Feb2021 14:30, at 71-year-old, as single dose (Lot Number: EN6198) for covid-19 immunisation. The patient had other medications in two weeks(not reported).  No other vaccine in four weeks. The patient had not got covid prior vaccination and had no covid tested post vaccination. No Known allergies. On Apr2021, the patient complained of large left toe had been hurting her for quite a while and would wake her up during night hurting. She got different opinions of what it may be. On 28May2021, the patient went to Urgent Care Clinic for painful toe since middle of night and blood pressure was abnormally high 169 over 103. On 03Jun2021, the patient had healthcare professional office visit for the high blood pressure and was feeling weak, very tired, legs weak, having heart palpitations, fast heartbeat in chest up to throat. The patient had these symptoms from May2021 to Jul2021. She couldn't walk very far because of weakness. On an unspecified date in 2021, patient went to emergency room because of dizziness that was very extreme. She was diagnosed with vertigo. Blood pressure was still very high. The patient had computerised tomogram (CT), bloodwork, electrocardiogram (EKG) which showed abnormal problems which included inferior infarction on 26Apr2021.  Other symptoms of something going on during May2021 to Aug2021, included: face would turn red, legs went out from under her, night sweats, restless legs, light temple headaches, short of breath, pain in hands, wrists, very cold feet, gas, burping. All of this happened to the patient out of the blue. Therapeutic measures were taken as a result of all events included: New blood pressure medicines, CT scans, blood works and 3 EKGs. The outcome of all events was recovered with lasting effects. The case was serious due to medically significant condition.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Night sweats, Pain in extremity, Palpitations, Peripheral coldness
Clinical narrative: Blood pressure was abnormally high 169 over 103.3; was feeling weak; very tired; legs weak/legs went out from under me; having heart palpitations; fast heartbeat in chest up to throat; face would turn red; night sweats; restless legs; light temple headaches; short of breath; pain in hands,wrist; very cold feet; gas; burping; EKG which showed abnormal problems which included inferior infarction; complained of large left toe had been hurting me for quite a while and would wake me up during night hurting; Went to E.R. because of dizziness that was very extreme; Was diagnosed with vertigo; This is a spontaneous report from a contactable consumer(patient). A 71-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 27Mar2021 14:30, at 71-year-old, as single dose (Lot Number: ER8727) for covid-19 immunisation. Medical history included pre diabetic, high cholesterol, thyroid and acid reflux. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 27Feb2021 14:30, at 71-year-old, as single dose (Lot Number: EN6198) for covid-19 immunisation. The patient had other medications in two weeks(not reported).  No other vaccine in four weeks. The patient had not got covid prior vaccination and had no covid tested post vaccination. No Known allergies. On Apr2021, the patient complained of large left toe had been hurting her for quite a while and would wake her up during night hurting. She got different opinions of what it may be. On 28May2021, the patient went to Urgent Care Clinic for painful toe since middle of night and blood pressure was abnormally high 169 over 103. On 03Jun2021, the patient had healthcare professional office visit for the high blood pressure and was feeling weak, very tired, legs weak, having heart palpitations, fast heartbeat in chest up to throat. The patient had these symptoms from May2021 to Jul2021. She couldn't walk very far because of weakness. On an unspecified date in 2021, patient went to emergency room because of dizziness that was very extreme. She was diagnosed with vertigo. Blood pressure was still very high. The patient had computerised tomogram (CT), bloodwork, electrocardiogram (EKG) which showed abnormal problems which included inferior infarction on 26Apr2021.  Other symptoms of something going on during May2021 to Aug2021, included: face would turn red, legs went out from under her, night sweats, restless legs, light temple headaches, short of breath, pain in hands, wrists, very cold feet, gas, burping. All of this happened to the patient out of the blue. Therapeutic measures were taken as a result of all events included: New blood pressure medicines, CT scans, blood works and 3 EKGs. The outcome of all events was recovered with lasting effects. The case was serious due to medically significant condition.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Restless legs syndrome, Vertigo
Clinical narrative: Blood pressure was abnormally high 169 over 103.3; was feeling weak; very tired; legs weak/legs went out from under me; having heart palpitations; fast heartbeat in chest up to throat; face would turn red; night sweats; restless legs; light temple headaches; short of breath; pain in hands,wrist; very cold feet; gas; burping; EKG which showed abnormal problems which included inferior infarction; complained of large left toe had been hurting me for quite a while and would wake me up during night hurting; Went to E.R. because of dizziness that was very extreme; Was diagnosed with vertigo; This is a spontaneous report from a contactable consumer(patient). A 71-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 27Mar2021 14:30, at 71-year-old, as single dose (Lot Number: ER8727) for covid-19 immunisation. Medical history included pre diabetic, high cholesterol, thyroid and acid reflux. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 27Feb2021 14:30, at 71-year-old, as single dose (Lot Number: EN6198) for covid-19 immunisation. The patient had other medications in two weeks(not reported).  No other vaccine in four weeks. The patient had not got covid prior vaccination and had no covid tested post vaccination. No Known allergies. On Apr2021, the patient complained of large left toe had been hurting her for quite a while and would wake her up during night hurting. She got different opinions of what it may be. On 28May2021, the patient went to Urgent Care Clinic for painful toe since middle of night and blood pressure was abnormally high 169 over 103. On 03Jun2021, the patient had healthcare professional office visit for the high blood pressure and was feeling weak, very tired, legs weak, having heart palpitations, fast heartbeat in chest up to throat. The patient had these symptoms from May2021 to Jul2021. She couldn't walk very far because of weakness. On an unspecified date in 2021, patient went to emergency room because of dizziness that was very extreme. She was diagnosed with vertigo. Blood pressure was still very high. The patient had computerised tomogram (CT), bloodwork, electrocardiogram (EKG) which showed abnormal problems which included inferior infarction on 26Apr2021.  Other symptoms of something going on during May2021 to Aug2021, included: face would turn red, legs went out from under her, night sweats, restless legs, light temple headaches, short of breath, pain in hands, wrists, very cold feet, gas, burping. All of this happened to the patient out of the blue. Therapeutic measures were taken as a result of all events included: New blood pressure medicines, CT scans, blood works and 3 EKGs. The outcome of all events was recovered with lasting effects. The case was serious due to medically significant condition.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Transient ischaemic attack
Clinical narrative: Six days after the booster developed shingles; Two days after receiving booster experienced a brief TIA; This is a spontaneous report from a contactable consumer(patient). A 72-year-old non-pregnant female patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 30Sep2021 11:30, at 72-year-old, as single dose (Lot Number: 301458A) for covid-19 immunisation.  Known allergies was ZPak. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 22Jan2021 at 10:00, at 72-year-old, as single dose (Lot Number: EL9262) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 12Feb2021 at 10:00, at 72-year-old, as single dose (Lot Number: EN6203) for covid-19 immunisation.  Concomitant medications included Losartan Potassium, Levothyroxine, Zaleplon. All concomitant drugs were taken for an unspecified indication. No other vaccine in four weeks. The patient had not got Covid prior vaccination and had not got Covid tested post vaccination. The patient reported two days after receiving booster experienced a brief transient ischaemic attack (TIA) on 02Oct2021 at 08:30 AM. Six days after the booster developed shingles on 06Oct2021. Therapeutic measures were taken as a result of all events included: appointment scheduled for Carotid Artery scan. The patient had a healthcare professional office/clinic visit for all events. The outcome of all events was recovered. The case was serious due to medically significant condition.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia, Pyrexia
Clinical narrative: Pneumonia; Fevers; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration in 2021 as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunization. After fevers for 6 days in 2021, the patient went into the emergency room (ER). They found out the patient had pneumonia. The patient believed that this was caused by the vaccine. The outcome of the events was unknown at the time of report.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: she received a Pfizer Biontech COVID19 (Comirnaty) vaccine and had multi inflammatory syndrome; This is a spontaneous report from a contactable consumer. This consumer reported for patient (daughter's boyfriend mom). A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient received a Pfizer Biontech COVID19 (Comirnaty) vaccine and had multisystem inflammatory disorder on an unspecified date. The reporter stated that she had heard of this only with patients that had Covid. The patient stated that she was told by the patient(nurse) that it was listed on side effects page. The reporter wanted to know what the truth was and trying to get clarification. The patient stated that she did not want her daughter to be influenced by misinformation. The outcome of event was unknown.    The lot number for bnt162b2, was not provided and will be requested during follow up.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Swelling face
Clinical narrative: now has Bell's Palsy on her face.; she had swelling in the face; This is a spontaneous report from a contactable consumer (caregiver, parent). A 19-year-old female patient (reporter's daughter) received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 05Oct2021 17:00 (Batch/Lot number was not reported) as dose 1, single at the age of 19 years old for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had Bell's Palsy on her face. She was fine until the next day after receiving the vaccine, on 06Oct2021 she had swelling in the face then she woke up and the left side of her face looked like she had a stroke. They took her to the hospital and it was determined she had Bell's Palsy from the vaccine. The doctor wrote a script for antiviral and steroid. Events resulted in physician office visit. Treatment received. The outcome of events was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Investigation, Malaise, Oral herpes
Clinical narrative: Shingles; Her reaction was very painful; Groggy; Didn't feel right; rash on her leg; itchy; Fatigue; Cold sores lip; This is a spontaneous report from a contactable consumer (patient, respiratory therapist). A 29-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in right deltoid on 04Jan2021 (Lot number EL1284 or ELI284) as dose 1, single at the age of 29-year-old for COVID-19 immunization. Medical history included eczema diagnosed maybe 6-7 years old, chicken pox, COVID-19 in Oct2020. There were no concomitant medications. The patient experienced shingles on 06Feb2021, fatigue in Jan2021, cold sores lip in Jan2021, groggy, didn't feel right in Jan2021, rash on her leg in Jan2021, itchy in Jan2021, her reaction was very painful. In Feb2021, caller was diagnosed with shingles that leads to several emergency room and hospital visits. From then on, she did not proceed in getting her 2nd dose following the AE she experienced. The seriousness of shingles was hospitalized and medically signficant. Within 1.5 weeks after the COVID-19 Vaccine, she started getting fatigued, got a cold sore, and then a rash on her leg. Rash was first itchy, then turned into sore and painful. The rash began spreading. She went to the ER. Was then diagnosed with shingles and got on an antiviral and it went away. Clarified she felt fatigued within the first week of the COVID-19 Vaccine. She didn't feel right. Had COVID-19 virus two to three months before that. She felt groggy and started developing a cold sore on her lip. Then noticed the rash on her leg. Then found out it was shingles because it was extremely painful. Had a lot of adverse reactions. Never attempted to get the second dose. Had to take a medication post visiting the Emergency Room on 06Feb2021. Clarified medication as Valacyclovir. She didn't respond well to the COVID-19 vaccine. Didn't take second dose. Works in the medical field. Has done the testing and is following protocol. Didn't want to get the second shot because she had to take the antiviral medication after the first dose. It was really bad. Has a form that needs to be filled out by an RN, Nurse Practitioner or a doctor that exempts her from receiving the second shot. Her reaction was very painful. Fatigue has improved drastically after she had the antiviral, but it took a while, at least 3-4 weeks before it went away. Had to cover up rash and patch it. Her body was shocked from the response. She has recovered. But is having more frequent cold sores that are still occurring. Shingles was on her right thigh. She has scars now. Had COVID-19 Virus in Oct2020. Diagnosed with shingles 06Feb2021. Put on Valacyclovir. It took a while, three to four weeks for it to go away. Unable to query NDC/LOT/EXP. Treatment received for shingles, fatigue. The outcome of shingles, rash on her leg was recovered in 2021. The outcome of fatigue was recovering. The outcome of cold sores lip was not recovered. The outcome of other events was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Somnolence
Clinical narrative: Shingles; Her reaction was very painful; Groggy; Didn't feel right; rash on her leg; itchy; Fatigue; Cold sores lip; This is a spontaneous report from a contactable consumer (patient, respiratory therapist). A 29-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in right deltoid on 04Jan2021 (Lot number EL1284 or ELI284) as dose 1, single at the age of 29-year-old for COVID-19 immunization. Medical history included eczema diagnosed maybe 6-7 years old, chicken pox, COVID-19 in Oct2020. There were no concomitant medications. The patient experienced shingles on 06Feb2021, fatigue in Jan2021, cold sores lip in Jan2021, groggy, didn't feel right in Jan2021, rash on her leg in Jan2021, itchy in Jan2021, her reaction was very painful. In Feb2021, caller was diagnosed with shingles that leads to several emergency room and hospital visits. From then on, she did not proceed in getting her 2nd dose following the AE she experienced. The seriousness of shingles was hospitalized and medically signficant. Within 1.5 weeks after the COVID-19 Vaccine, she started getting fatigued, got a cold sore, and then a rash on her leg. Rash was first itchy, then turned into sore and painful. The rash began spreading. She went to the ER. Was then diagnosed with shingles and got on an antiviral and it went away. Clarified she felt fatigued within the first week of the COVID-19 Vaccine. She didn't feel right. Had COVID-19 virus two to three months before that. She felt groggy and started developing a cold sore on her lip. Then noticed the rash on her leg. Then found out it was shingles because it was extremely painful. Had a lot of adverse reactions. Never attempted to get the second dose. Had to take a medication post visiting the Emergency Room on 06Feb2021. Clarified medication as Valacyclovir. She didn't respond well to the COVID-19 vaccine. Didn't take second dose. Works in the medical field. Has done the testing and is following protocol. Didn't want to get the second shot because she had to take the antiviral medication after the first dose. It was really bad. Has a form that needs to be filled out by an RN, Nurse Practitioner or a doctor that exempts her from receiving the second shot. Her reaction was very painful. Fatigue has improved drastically after she had the antiviral, but it took a while, at least 3-4 weeks before it went away. Had to cover up rash and patch it. Her body was shocked from the response. She has recovered. But is having more frequent cold sores that are still occurring. Shingles was on her right thigh. She has scars now. Had COVID-19 Virus in Oct2020. Diagnosed with shingles 06Feb2021. Put on Valacyclovir. It took a while, three to four weeks for it to go away. Unable to query NDC/LOT/EXP. Treatment received for shingles, fatigue. The outcome of shingles, rash on her leg was recovered in 2021. The outcome of fatigue was recovering. The outcome of cold sores lip was not recovered. The outcome of other events was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Investigation, Nasal disorder, Nasal septum deviation, Vocal cord inflammation
Clinical narrative: deviated septum; Narrow passageways in her nose/airways were very small; Infected vocal cords; A week later woke up with no voice/Could not talk at all; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in right arm on 21Aug2021 around 11:00-12:00 (Lot Number: FC3182) as dose 2, single at the age of 63-year-old for COVID-19 immunization. No medical history. There were no concomitant medications. Historic vaccine was 1st dose of bnt162b2 received on 31Jul2021 (Lot Number: FA7484) as a single dose at the age of 63 years old for COVID-19 immunization. A week later in Aug2021 she woke up with no voice in the morning and couldn't talk at all. A few days later she had barely a whisper. This went on for 2 weeks and she saw an Ear, Nose, and Throat doctor and the doctor recommended the caller report her experience because he hadn't heard of it before. She just had the Covid 19 vaccine and then this happened. The doctor told her that her vocal cords were infected and she has to have surgery. She was prescribed medication because she didn't have her voice back. She took steroids and antibiotics and she finished the medicine and her voice started coming back. The doctor tried to put a camera up her nose and down her throat and the doctor couldn't even get the camera up her nostril. The doctor told her she had narrow passageways in her nose. She was concerned why this happened. She had to get blood work before her surgery. She was having surgery for a deviated septum. She did not know if that was relevant to her losing her voice. The doctor couldn't get the camera in one nostril but the other nostril was fine. Her airways were very small and she wanted to use a CPAP machine but she had to breathe through her nose to use the CPAP. She lost her voice a week after getting the second Covid 19 vaccine and her husband told her she had better go to the Ear, Nose, and Throat doctor. She had never seen the Ear, Nose and Throat doctor before. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. No emergency room visit. Events resulted in physician office visit. Treatment received. The outcome of Infected vocal cords and woke up with no voice/Could not talk at all was recovering. The outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.