chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pruritus
Clinical narrative: difficulty breathing; chest tightness; feeling itchy with some chest tightness; O2 sat 70%; not feeling well; This is a spontaneous report from a contactable Nurse. A 67-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EN6202), via intramuscular route of administration at arm right on 27Feb2021 14:45 (02:45 PM) (at the age of 67-year-old) at single dose for COVID-19 immunization. The patient medical history included allergies to penicillin, iodine contrast, cephalosporins. The patient concomitant medications were not reported. Patient did not receive other vaccine in four weeks. The patient was not diagnosed with covid prior vaccination. It was unknown whether the patient was tested for covid post vaccination. Patient did not receive other medications in two weeks. The patient experienced difficulty breathing, chest tightness, feeling itchy with some chest tightness, O2 sat 70%, not feeling well on 27Feb2021 14:45 (02:45 PM). Adverse event: after vaccine administration patient ambulated to the 15 minute hold location, during that time patient began to close eyes and reported not feeling well, patient husband was with her and notified staff, patient taken to private location and evaluated by nursing staff, patient barely able to state name, reported chest tightness, difficulty breathing, heart rate was 88, O2 sat 70%, administered one dose of epinephrine and administered 10L of O2 vis facemask, vital signs obtained and EMS services contacted, patient able to state name and location, reported feeling itchy with some chest tightness, continued to montior vitals until EMS services arrived. AE resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included heart rate was 88, O2 sat was 70% on 27Feb2021. The patient received epinephrine as a treatment medication and patient taken to ER (emergency room) for further evaluation for the events difficulty breathing, chest tightness, feeling itchy with some chest tightness, O2 sat 70%, not feeling well. Outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.  ; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of dyspnea and other. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Breast abscess, Infection, Pain in extremity
Clinical narrative: she had an abscess on her breast, with puss coming out like a bump; arm hurts; infection; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9269 and expiration date was not reported) via an unspecified route of administration on 08Feb2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date patient had the first dose (2 weeks ago) and went to doctor last week Wednesday (On unspecified date) thought it was a lump, but the doctor lifted the breast and the infection poured out. the patient had an abscess on her breast, with puss coming out it was like a bump, and patient was given (doxycycline 100mg) for the infection at the doctor's office. Patient arm hurts she started on hold with 35 people, she does not want to hold anymore. Patient wanted to know if she can get the second dose that is on 25Feb2021, which would be Thursday. The clinical outcome of the events was unknown. No follow up attempts are possible. No further information is expected..
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: moderate injection site pain; headache; chills; joint pain; muscle pain; very slight nausea; tiredness; This is a spontaneous report from a contactable other HCP (patient) reporting herself. A 75-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6203; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 21Feb2021 10:30 as single dose for COVID-19 immunization. Medical history included moderate atherosclerosis, drug hypersensitivity; penicillin allergy from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (ATORVASTATIN), lisinopril (LISINOPRIL) and colecalciferol (VIT D3) taken for an unspecified indication. The patient previously took cephalosporin c and experienced drug hypersensitivity. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN5318; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 31Jan2021 10:15 as single dose for COVID-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. It was reported that on 22Feb2021 04:00 patient experienced moderate injection site pain, headache, chills, joint and muscle pain, very slight nausea, tiredness within 18 hours after the second dose. Patient had not received any treatment for the adverse events. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was recovered, after the 8 hours of onset.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: moderate injection site pain; headache; chills; joint pain; muscle pain; very slight nausea; tiredness; This is a spontaneous report from a contactable other HCP (patient) reporting herself. A 75-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6203; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 21Feb2021 10:30 as single dose for COVID-19 immunization. Medical history included moderate atherosclerosis, drug hypersensitivity; penicillin allergy from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (ATORVASTATIN), lisinopril (LISINOPRIL) and colecalciferol (VIT D3) taken for an unspecified indication. The patient previously took cephalosporin c and experienced drug hypersensitivity. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN5318; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 31Jan2021 10:15 as single dose for COVID-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. It was reported that on 22Feb2021 04:00 patient experienced moderate injection site pain, headache, chills, joint and muscle pain, very slight nausea, tiredness within 18 hours after the second dose. Patient had not received any treatment for the adverse events. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was recovered, after the 8 hours of onset.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Urinary tract infection
Clinical narrative: UTI Infection; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 74-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EL9269, expiration date was not reported), via an unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization, amoxicillin for urinary tract infection. Medical history included urinary tract infection from an unknown date She unfortunately came down with a UTI Infection which she usually gets. The patient's concomitant medications were not reported. On Feb2021 the patient experienced uti infection. Caller mentioned that she received the 1st dose of the vaccine 06Feb2021. She mentioned that she had no problem with it. It was very smooth, great and didn't feel it.  She unfortunately came down with a UTI Infection which she usually gets. Her doctor prescribed her Amoxicillin. She is asking if that medication would have any adverse effects with her 2nd dose which is due tomorrow. She is planning to hold off on the amoxicillin until Wednesday after getting the 2nd dose. Up on follow up(01Mar2021) Patient stated that I just want to know should I not take the Amoxicillin before I get my dosage tomorrow for my vaccine (Unspecified Vaccine) should I put that off, and take it later or can I take it today and not take it tomorrow, and take it back up on Wednesday, The Amoxicillin going to have any negative effect on the vaccine, is to not take the medicine (Amoxicillin) for urinary tract infection and just go ahead and get my vaccine since I already have one dose. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Peripheral swelling
Clinical narrative: increased SOB; legs much more swollen; feeling bad; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (74, units not provided) received bnt162b2 (PFIZER-BINTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 13Feb2021 as 1st dose, single for COVID-19 immunization. Medical history included multiple back surgeries in the past and leukemia, lymphoedema of legs (in treatment now). The patient's concomitant medications were not reported. The patient reported that post 1st dose of vaccine, she had pretty terrible reaction, feeling bad, wanted to go to bed, legs much more swollen and increased shortness of breath. The patient stated that shortness of breath was common for her. The patient stated that her legs always swell after surgeries. The patient stated that she heard that 2nd dose was worse for symptoms. She stated that other say it was much more painful. The patient asked if she should get the 2nd dose, or will her symptoms be worse and asked why the 2nd dose was worse/what causes it to be worse. The patient asked if she should wait to get 2nd dose so that the vaccine will decrease in her symptom to prevent side effects for the 2nd dose. The clinical outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chest discomfort, Chills, Dyspnoea
Clinical narrative: chills; hot flashes; developed difficulty breathing; chest discomfort; body aches; Joint pain; 100.1F; This is a spontaneous report from a contactable consumer (patient). A female patient of 56 (units not provided) age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 28Feb2021 as single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 09Feb2021 for COVID-19 immunisation and had no symptoms. Medical history included ongoing asthma. The patient's concomitant medications were not reported. She received second dose on 28Feb2021 and that evening at 11pm developed difficulty breathing, chills for a few hours, hot flashes and chills. Then at 5am, she developed body aches, joint pain, 100.1F. Last night, she felt better. This morning she having chest discomfort, no pain, no difficulty breathing. She used her inhaler and it "calmed down" a little bit. She wants to know this is common side effect or should she see doctor. The patient underwent lab tests and procedures which included body temperature: 100.1F. The patient received treatments due to difficulty breathing with inhaler. The outcome of developed difficulty breathing and chest discomfort was unknown, while with other events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Pain, Pyrexia
Clinical narrative: chills; hot flashes; developed difficulty breathing; chest discomfort; body aches; Joint pain; 100.1F; This is a spontaneous report from a contactable consumer (patient). A female patient of 56 (units not provided) age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 28Feb2021 as single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 09Feb2021 for COVID-19 immunisation and had no symptoms. Medical history included ongoing asthma. The patient's concomitant medications were not reported. She received second dose on 28Feb2021 and that evening at 11pm developed difficulty breathing, chills for a few hours, hot flashes and chills. Then at 5am, she developed body aches, joint pain, 100.1F. Last night, she felt better. This morning she having chest discomfort, no pain, no difficulty breathing. She used her inhaler and it "calmed down" a little bit. She wants to know this is common side effect or should she see doctor. The patient underwent lab tests and procedures which included body temperature: 100.1F. The patient received treatments due to difficulty breathing with inhaler. The outcome of developed difficulty breathing and chest discomfort was unknown, while with other events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dysarthria, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: swelling of tongue; difficulty breathing; headache (bad one); numbness in right side; confusion; swelling of face; slurry words; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EM9810, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Feb2021 at 09:00 am (age at vaccination was 50 years) as 1st dose, single for COVID-19 immunization. Medical history included asthma. The patient had known allergies to iodine, shrimp and iodide (like the CATSCAN contrast fluid). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) and One-A-Day Mens over 50 vitamin. The patient previously received first dose of flu shot in upper right arm on 12Jan2021. The facility where the most recent COVID-19 vaccine was administered was Hospital. On 10Feb2021 at 15:00 pm, the patient experienced swelling of tongue, face, confusion, slurry words, difficulty breathing, no pains though, headache (bad one) and numbness in right side. The patient received treatment with DECADRON (steroid) and Diphenhydramine (Benadryl). Since the vaccination, the patient has been tested for COVID-19. The patient underwent Nasal Swab COVID test (COVID Nasal/Nasopharynx COVID test) on 28Feb2021 and the result was negative. The outcome of the events was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling face, Swollen tongue
Clinical narrative: swelling of tongue; difficulty breathing; headache (bad one); numbness in right side; confusion; swelling of face; slurry words; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EM9810, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Feb2021 at 09:00 am (age at vaccination was 50 years) as 1st dose, single for COVID-19 immunization. Medical history included asthma. The patient had known allergies to iodine, shrimp and iodide (like the CATSCAN contrast fluid). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) and One-A-Day Mens over 50 vitamin. The patient previously received first dose of flu shot in upper right arm on 12Jan2021. The facility where the most recent COVID-19 vaccine was administered was Hospital. On 10Feb2021 at 15:00 pm, the patient experienced swelling of tongue, face, confusion, slurry words, difficulty breathing, no pains though, headache (bad one) and numbness in right side. The patient received treatment with DECADRON (steroid) and Diphenhydramine (Benadryl). Since the vaccination, the patient has been tested for COVID-19. The patient underwent Nasal Swab COVID test (COVID Nasal/Nasopharynx COVID test) on 28Feb2021 and the result was negative. The outcome of the events was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 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.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise
Clinical narrative: shortness of breath and sounds like a rattle snake when she is breathing in and out; she did not feel well; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shortness of breath and sounds like a rattle snake when she was breathing in and out on an unspecified date. She thinks she was having a reaction. She had COVID shot on Saturday. The last three days when she lays down, especially at night, she had shortness of breath and sounds like a rattle snake when she was breathing in and out. It was so loud it keeps her up at night. She had googled stuff. She was out of breath. It said to drink warm water and drink something hot. She had an ALBUTEROL Inhaler. The inhaler was not working. It works for the first 15 minutes, but the moment she lays down it gets worse. She had been sitting up with pillows at night. Patient clarified that she was calling to see if that was a side effect. Patient declined to proceed with a report at this time as she did not feel well and had to work. Therapeutic measures were taken as a result of shortness of breath and sounds like a rattle snake when she was breathing in and out include ALBUTEROL Inhaler. The outcome for events was unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling of body temperature change, Haemoptysis, Heart rate
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via Accredo specialty pharmacy based on the information received by Pfizer from United Therapeutics (E2B Report Duplicate: UNT-2021-002875). A 72-year-old female patient began therapy with IH Tyvaso (treprostinil sodium, concentration of Inhalation Gas, (0.6 mg/ml) via Inhalation on 01Sep2020 to Unknown date then 18-54 µg, qid, Inhalation on 09 Jan 2020 to unknown date (Lot #: 2101898, Exp. date: 31Oct2021) after that via Inhalation (Lot: 2101910 Exp. date: 31Oct2021); then 42 µg, Inhalation, after that 30 µg, Inhalation on Jan 2021 to unknown date for primary pulmonary arterial hypertension. On unknown dates in Mar 2021, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, first and second dose as single doses for COVID-19 immunisation. The patient's medical history included ongoing pulmonary arterial hypertension. Concomitant medications were not provided. On an unreported date, the patient experienced shortness of breath with COVID-19 vaccine, hot face and then freezing, heart rate up to 100 bpm (beats per minute) and increased O2- to 6l, average O2 saturation 87 %, dizziness. On an unreported date, the patient experienced the event term of 'cough had bright red bleeding. Co-suspect medication included COVID-19 vaccine. Patient was on continuous oxygen at 3.5 liters. The reporter did not provide causality for the events of dyspnoea, feeling of body temperature change, heart rate increased, and oxygen saturation decreased. Relevant Tests/Laboratory Data: Heart rate 100 /min and Feb 2021, Oxygen saturation 87 %, oxygen levels have dropped to 70 (%) and 80 (%); on 22Mar2021, low oxygen saturation in 50(%) and 60 (%) was 85(%); stays lower than the normal 94(%) [Oxygen saturation decreased]. The reporter did not provide causality for the events of dyspnoea, feeling of body temperature change, heart rate increased, and oxygen saturation decreased. The patient further had cough that had bright red bleeding. The outcome of the events of increased O2- to 6l, average O2 sat 87% was not recovered; shortness of breath with COVID-19 vaccine and dizziness was recovering; cough had bright red bleeding and hot face and then freezing was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided in the narrative, the causal association between the suspect drug and the events 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.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via Accredo specialty pharmacy based on the information received by Pfizer from United Therapeutics (E2B Report Duplicate: UNT-2021-002875). A 72-year-old female patient began therapy with IH Tyvaso (treprostinil sodium, concentration of Inhalation Gas, (0.6 mg/ml) via Inhalation on 01Sep2020 to Unknown date then 18-54 µg, qid, Inhalation on 09 Jan 2020 to unknown date (Lot #: 2101898, Exp. date: 31Oct2021) after that via Inhalation (Lot: 2101910 Exp. date: 31Oct2021); then 42 µg, Inhalation, after that 30 µg, Inhalation on Jan 2021 to unknown date for primary pulmonary arterial hypertension. On unknown dates in Mar 2021, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, first and second dose as single doses for COVID-19 immunisation. The patient's medical history included ongoing pulmonary arterial hypertension. Concomitant medications were not provided. On an unreported date, the patient experienced shortness of breath with COVID-19 vaccine, hot face and then freezing, heart rate up to 100 bpm (beats per minute) and increased O2- to 6l, average O2 saturation 87 %, dizziness. On an unreported date, the patient experienced the event term of 'cough had bright red bleeding. Co-suspect medication included COVID-19 vaccine. Patient was on continuous oxygen at 3.5 liters. The reporter did not provide causality for the events of dyspnoea, feeling of body temperature change, heart rate increased, and oxygen saturation decreased. Relevant Tests/Laboratory Data: Heart rate 100 /min and Feb 2021, Oxygen saturation 87 %, oxygen levels have dropped to 70 (%) and 80 (%); on 22Mar2021, low oxygen saturation in 50(%) and 60 (%) was 85(%); stays lower than the normal 94(%) [Oxygen saturation decreased]. The reporter did not provide causality for the events of dyspnoea, feeling of body temperature change, heart rate increased, and oxygen saturation decreased. The patient further had cough that had bright red bleeding. The outcome of the events of increased O2- to 6l, average O2 sat 87% was not recovered; shortness of breath with COVID-19 vaccine and dizziness was recovering; cough had bright red bleeding and hot face and then freezing was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided in the narrative, the causal association between the suspect drug and the events 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.
Sex: F
Vaccine: COVID19
Symptoms: Cystocele, Urinary tract infection
Clinical narrative: UTI; Dropped bladder; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced UTI (urinary tract infection) but she had a dropped bladder and she do get frequent UTI's. Therapeutic measures were taken and She was on Keflex for a UTI and scheduled Thursday for her second dose and inquired Is it ok to get the vaccine while taking Keflex. The outcome of the events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Rash, Swelling
Clinical narrative: Difficulty breathing; swelling; rash; dizzy; This is a spontaneous report from a contactable consumer (patient him/herself). A 30-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200) via an unspecified route of administration, administered in right arm on 14Feb2021 15:00 (age at vaccination: 30 years) as first dose, single dose for COVID-19 immunization. The patient medical history included epilepsy and diabetes. The patient received other unspecified vaccine in two weeks. There was patient known allergies. On 14Feb2021 16:00, the patient had difficulty breathing, swelling, rash and dizzy. The adverse events resulted in emergency room visit requiring treatment of IV with meds (unspecified). The patient did not receive any other vaccine in four weeks. The patient did not receive any prior covid vaccination nor was tested positive for covid post vaccination. The outcome of all the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Decreased appetite, Insomnia, Pain
Clinical narrative: UTI; Sore; pain in my shoulder; back pain; Sleeplessness; no appetite; This is a spontaneous report from a contactable consumer (Patient). This 80-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: el9266) via an unspecified route of administration on 19Feb2021 as 2nd dose, single for COVID-19 immunization. The patient medical history included knee and shoulder replacement. Concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: el9261) via an unspecified route of administration on 29Jan2021 as single dose for COVID-19 immunisation. The patient reported that she had never been so sore in her whole life and to tell how healthy she usually was, she only takes one pill for her bladder and she was 80 years old. After receiving the second dose, the third day on 22Feb2021, she got a UTI (Urinary tract infection), it may have been a coincidence but this was the first time in her life, she had a UTI. Also, the body pain was excruciating, She had been active and healthy up until this. Yesterday, she could hardly get out of bed because the pain in her shoulder was so excruciating, she could not move. She has never been so miserable in her life and had knee and shoulder replacement, this was the worse. She had no appetite and all wanted to do was sleep. People said they had the pain and ache but she never had back ache like that, it was in one spot and it was on fire and it did not do anything to aggravate it or to bring it on, and all this sleeplessness. Her UTI has been treated and she takes ibuprofen for the pain. Outcome was resolved for event UTI and unknown for rest of the events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; Sore; pain in my shoulder; back pain; Sleeplessness; no appetite; This is a spontaneous report from a contactable consumer (Patient). This 80-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: el9266) via an unspecified route of administration on 19Feb2021 as 2nd dose, single for COVID-19 immunization. The patient medical history included knee and shoulder replacement. Concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: el9261) via an unspecified route of administration on 29Jan2021 as single dose for COVID-19 immunisation. The patient reported that she had never been so sore in her whole life and to tell how healthy she usually was, she only takes one pill for her bladder and she was 80 years old. After receiving the second dose, the third day on 22Feb2021, she got a UTI (Urinary tract infection), it may have been a coincidence but this was the first time in her life, she had a UTI. Also, the body pain was excruciating, She had been active and healthy up until this. Yesterday, she could hardly get out of bed because the pain in her shoulder was so excruciating, she could not move. She has never been so miserable in her life and had knee and shoulder replacement, this was the worse. She had no appetite and all wanted to do was sleep. People said they had the pain and ache but she never had back ache like that, it was in one spot and it was on fire and it did not do anything to aggravate it or to bring it on, and all this sleeplessness. Her UTI has been treated and she takes ibuprofen for the pain. Outcome was resolved for event UTI and unknown for rest of the events.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The parent falsified the child's birthdate to make it look like he was 12 years old and eligible to receive the covid vaccine. There was no known adverse reaction.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe joint pain. Ankles and wrists
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Adenovirus test, Asthenia, Bordetella test negative, COVID-19
Clinical narrative: Asymptomatic screening for admission for AKI ED to Hosp-Admission Current  6/22/2021 - present (3 days)   MD Last attending ? Treatment team AKI (acute kidney injury) (CMS/HCC) Principal problem    Review of Systems  Constitutional: Negative for chills and fever.       General weakness.  HENT: Negative for ear pain and sore throat.   Eyes: Negative for pain and visual disturbance.  Respiratory: Positive for shortness of breath. Negative for cough.   Cardiovascular: Positive for leg swelling. Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain and vomiting.  Genitourinary: Negative for dysuria and hematuria.  Musculoskeletal: Negative for arthralgias and back pain.  Skin: Negative for color change and rash.  Neurological: Negative for seizures and syncope.  All other systems reviewed and are negative.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chlamydia test negative, Condition aggravated, Coronavirus test negative, Dyspnoea, Enterovirus test negative
Clinical narrative: Asymptomatic screening for admission for AKI ED to Hosp-Admission Current  6/22/2021 - present (3 days)   MD Last attending ? Treatment team AKI (acute kidney injury) (CMS/HCC) Principal problem    Review of Systems  Constitutional: Negative for chills and fever.       General weakness.  HENT: Negative for ear pain and sore throat.   Eyes: Negative for pain and visual disturbance.  Respiratory: Positive for shortness of breath. Negative for cough.   Cardiovascular: Positive for leg swelling. Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain and vomiting.  Genitourinary: Negative for dysuria and hematuria.  Musculoskeletal: Negative for arthralgias and back pain.  Skin: Negative for color change and rash.  Neurological: Negative for seizures and syncope.  All other systems reviewed and are negative.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Human metapneumovirus test, Human rhinovirus test, Influenza A virus test negative, Influenza virus test negative, Mycoplasma test negative
Clinical narrative: Asymptomatic screening for admission for AKI ED to Hosp-Admission Current  6/22/2021 - present (3 days)   MD Last attending ? Treatment team AKI (acute kidney injury) (CMS/HCC) Principal problem    Review of Systems  Constitutional: Negative for chills and fever.       General weakness.  HENT: Negative for ear pain and sore throat.   Eyes: Negative for pain and visual disturbance.  Respiratory: Positive for shortness of breath. Negative for cough.   Cardiovascular: Positive for leg swelling. Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain and vomiting.  Genitourinary: Negative for dysuria and hematuria.  Musculoskeletal: Negative for arthralgias and back pain.  Skin: Negative for color change and rash.  Neurological: Negative for seizures and syncope.  All other systems reviewed and are negative.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Respiratory syncytial virus test negative, Respiratory viral panel, SARS-CoV-2 test positive
Clinical narrative: Asymptomatic screening for admission for AKI ED to Hosp-Admission Current  6/22/2021 - present (3 days)   MD Last attending ? Treatment team AKI (acute kidney injury) (CMS/HCC) Principal problem    Review of Systems  Constitutional: Negative for chills and fever.       General weakness.  HENT: Negative for ear pain and sore throat.   Eyes: Negative for pain and visual disturbance.  Respiratory: Positive for shortness of breath. Negative for cough.   Cardiovascular: Positive for leg swelling. Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain and vomiting.  Genitourinary: Negative for dysuria and hematuria.  Musculoskeletal: Negative for arthralgias and back pain.  Skin: Negative for color change and rash.  Neurological: Negative for seizures and syncope.  All other systems reviewed and are negative.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Musculoskeletal stiffness
Clinical narrative: Post 2nd Dose: Stiff neck accompanied with pressure spreading down to bilateral shoulders. Pressure absent the next day, stiff neck lasting approximately 24-32 hours from onset.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine increased, Dizziness, Nausea, Transient ischaemic attack
Clinical narrative: Patient presented to the ED with dizziness/lightheadedness and nausea, was diagnosed with TIA and elevated serum creatinine within 6 weeks of receiving COVID vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Nervousness, Palpitations
Clinical narrative: A few minutes after the shot I starting feeling faint and heart racing. Mouth was dry and felt nervous.
Sex: F
Vaccine: COVID19
Symptoms: Abscess limb
Clinical narrative: She has an abscess on her finger; This is a spontaneous report from a contactable consumer reported (for wife). A female patient of a 61 (unit: unknown) age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 01Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Patient received unspecified concomitant therapy. She had the first dose of Pfizer COVID vaccine on 01Mar2021. She has an abscess on her finger on an unspecified date in 2021. NP gave her antibiotic-cephalexin 500mg. She wanted to confirm that taking the antibiotic would it affect the efficacy of the vaccine. She stated that abscess has nothing to do with the vaccine. The patient receive treatment for the event with antibiotic-cephalexin 500mg. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Contraceptive implant, Dysmenorrhoea, Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Menstruated twice in April; twice in May and then 3 times in June. In April, they were slightly heavier. In May, they started to get even heavier and even more painful. In June, I was bleeding extremely heavy. They lasted almost a whole week each time. I was in excruciating pain. I have an IUD. I was barely getting a period. When I did, it was light spotting a day or two prior to receiving the second dose of the vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bed rest, Cardiac function test, Chills, Myocarditis
Clinical narrative: 1st shot myocarditis 2nd  fever , chills hard to get out of bed
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Heart rate increased, Palpitations
Clinical narrative: Pt states 04/08/2021 awaken by a rapid heartbeat, irregular (skipping beats/fluttering). 04/09/2021 Contact with Physician 14th Heart monitor no irregular signs seen, self checks continue per (Cardiologist) Reports since then once a month, couple days irregular palpations reporting (May, June) Continues to monitor.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Sore arm, body aches, sore throat, cough
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Urticaria
Clinical narrative: became allergic to shell fish, grass, some spices, dust mites, environmental allergies, hives everyday
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac arrest, Cardiac telemetry, SARS-CoV-2 test positive, Troponin I increased
Clinical narrative: Patient vaccinated on 6/23/2021. Patient later found down by guard in cardiac arrest. Patient revived and transported via EMS to HCF.  Patient admitted 6/24/2021 and tested positive for COVID-19 (patient's first known positive in October 2020). Patient currently in the COVID unit on a telemetry monitor.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Hemiparesis, Transient ischaemic attack
Clinical narrative: Exactly a week after the first dose of Pfizer pt had a TIA. Was taken by ambulance to the hospital. Lost usage of right side and couldn't speak for roughly 30 mins. Pt states hospital found no reason for the TIA.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Severe chest pain went ER after 12 hours of injection.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: I broke out with hives and itching and I was advised to get over the counter Benadryl and that did not work. The hives continued.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Flushing, Loss of consciousness, Nervousness, Skin warm
Clinical narrative: I gave the first dose of Pfizer Covid vaccine to patient.  She was extremely nervous for the vaccine and passed out after about 5 minutes from receiving the shot. She came to within 10 seconds. She was momentarily disoriented and warm to the touch. Her face was flushed. I monitored her breathing and gave her a cool cloth and water. I kept her sitting for 30 minutes with her family and checked on her every 5 minutes. She left alert and functional.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Productive cough, SARS-CoV-2 test, Secretion discharge
Clinical narrative: MUCUS PRODUCING COUGH , EAR INFECTIONS,
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: ischemic stroke, tPA, no lasting physical effects detected
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Ischaemic stroke
Clinical narrative: ischemic stroke, tPA, no lasting physical effects detected
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, Atrial fibrillation, COVID-19 pneumonia, Cardiac failure acute
Clinical narrative: Death:   5/3/2021 Causes of death listed on death certificate: -1) Acute hypoxic respiratory failure  2) Acute on chronic diastolic heart failure  3) Atrial fibrillation  4) Covid 19 pneumonia  Other: Hypertension. Acute toxic encephalopathy. Type 2 diabetes. Esophageal dysphagia. Debility. Depression. Moderate malnutrition.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Depression, Dysphagia, Hypertension, Left ventricular failure
Clinical narrative: Death:   5/3/2021 Causes of death listed on death certificate: -1) Acute hypoxic respiratory failure  2) Acute on chronic diastolic heart failure  3) Atrial fibrillation  4) Covid 19 pneumonia  Other: Hypertension. Acute toxic encephalopathy. Type 2 diabetes. Esophageal dysphagia. Debility. Depression. Moderate malnutrition.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malnutrition, Nucleic acid test, Polymerase chain reaction, Toxic encephalopathy, Type 2 diabetes mellitus
Clinical narrative: Death:   5/3/2021 Causes of death listed on death certificate: -1) Acute hypoxic respiratory failure  2) Acute on chronic diastolic heart failure  3) Atrial fibrillation  4) Covid 19 pneumonia  Other: Hypertension. Acute toxic encephalopathy. Type 2 diabetes. Esophageal dysphagia. Debility. Depression. Moderate malnutrition.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Heart rate irregular, Injection site rash, Injection site swelling
Clinical narrative: Shivers, nausea, congestion, rash/swelling on right arm below injection site, aches, headache, nervous heart beat.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Respiratory tract congestion
Clinical narrative: Shivers, nausea, congestion, rash/swelling on right arm below injection site, aches, headache, nervous heart beat.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: DIZZINESS, ANXIETY
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Balance disorder, Ear discomfort, Ear, nose and throat examination, Head discomfort
Clinical narrative: Tinatus, started slowly then constant ringing,  loss of equilibrium, head and ear pressure that will not go away.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinatus, started slowly then constant ringing,  loss of equilibrium, head and ear pressure that will not go away.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath and difficulty breathing; This is a spontaneous report from a contactable other health professional (patient). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on 02Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced shortness of breath and difficulty breathing on 03Mar2021. Therapeutic measures were taken as a result of shortness of breath in the ER with Prednisone. The Patient wanted to know whether she could take second dose after this. The outcome of the event was unknown.   No follow-up attempts are possible. No further information was expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Dizziness, Dysuria, Eyelid pain
Clinical narrative: At first I had a headache and nausea. I was trying to concentrate on work, I felt tired and dizzy, and My headache was really bad. i left work early. When I got home I had body aches, I couldn't eat because of nausea. I developed fever of 102 and chills, It flared up my RA whole body hurt to move, tingling all over it hurt to even blink my eyes. It hurt to pee. I developed vertigo.  On the third I went to work still had headache, body aches, and nausea. It it took a week for me to feel better.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Headache, Impaired work ability, Malaise, Nausea
Clinical narrative: At first I had a headache and nausea. I was trying to concentrate on work, I felt tired and dizzy, and My headache was really bad. i left work early. When I got home I had body aches, I couldn't eat because of nausea. I developed fever of 102 and chills, It flared up my RA whole body hurt to move, tingling all over it hurt to even blink my eyes. It hurt to pee. I developed vertigo.  On the third I went to work still had headache, body aches, and nausea. It it took a week for me to feel better.