chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Urticaria
Clinical narrative: hives following both doses About a week 10 days following my first dose of Gardasil 9 I got hives. The second dose also gave me hives in March. They start on the back and the migrate to the breasts. I am taking the doses in the recommended time frame.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Psoriasis
Clinical narrative: My torso started to get psoriasis spots in various places.  There is no history of psoriasis in my family, nor have I ever had skin problems before.  I took a blood test at medical center, and it showed that I was positive for this (something about a gene got switched on I think - I'm not a medical person).  We do not know if this was from the vaccine(s) or just something happening because I'm old and have lupus.  It was odd that it happened after the 3rd dose of Moderna dose, however.  I can live with this, but I wanted to let you know as it happened after the 3rd dose of Moderna.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient came in for a covid booster, I went and drew up the vaccine and gave patient 0.3 ml. After patient left I realized the vial was/had expired. No symptoms at time of immunization was given. Informed/called patient after he left & informed him what happened. Informed PCP as well, & we rescheduled patient to come back in 4 days to provide patient w/ correct dose & up to date.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Feeling abnormal
Clinical narrative: extra fussy over the past 1-2 days. No fevers
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, C-reactive protein, Computerised tomogram abnormal, Computerised tomogram neck, Hypersensitivity
Clinical narrative: Muscle aches from Lt shoulder to Right shoulder. Hair falling out. All eyebrows fell out. Lost  some eye lashes. Hyper-sensitivity on face & head
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Madarosis, Musculoskeletal disorder, Myalgia
Clinical narrative: Muscle aches from Lt shoulder to Right shoulder. Hair falling out. All eyebrows fell out. Lost  some eye lashes. Hyper-sensitivity on face & head
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Lip swelling
Clinical narrative: Narrative: Received vaccine at outside facility. Per PCP note 2/24/22: "She had a reaction after receiving J&J covid-19 vaccine -flushing, lip swelling. She spoke to her immunologist about it. They don't think she is allergic to the excipient because same excipient is used for dupixant. So she may be allergic to the covid-19 viral particle."
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Narrative: The accepted caregiver/spouse paperwork since not in the system and administered a moderna COVID first dose vaccine to a 16 year old without verifying age.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Laboratory test normal
Clinical narrative: Narrative: 36 YOF who received J&J vaccine & remained in facility for 15 minutes following vaccination. Patient subsequently taken to ED by ambulance the day following vaccination due to complaints of chest pain & SOB. Patient reports that all results were normal at hospital. No additional details known.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebellar infarction, Magnetic resonance imaging head abnormal, Transient ischaemic attack
Clinical narrative: Narrative:  74 yo M with a PMH of colon cancer who received second COVID-19 vaccination and subsequently experienced TIA 48 hours later. Patient was seen at OSH where MRI revealed chronic right cerebellar infart. No additional details known.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain
Clinical narrative: Narrative:  65 YOM who presented to clinic for second Pifzer COVID vaccination. Allergy entered for generalized aches & pain, however no documentation regarding reaction. No additional details known.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Narrative: 64 YOM who presents to clinic for Pfizer COVID-19 vaccination. Allergy was reported following administration of second vaccination dose. Patient reports symptoms lasted for lasted 3-6 days. No other details documented.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Narrative: On 9/16/2021 patient reported he had COVID 19 vaccine in March 2021 and had to be in ER for several hours. Required treatment with epinephrine per patient report. No other information about vaccine available.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Feeling cold, Myalgia
Clinical narrative: Narrative:  Patient is a 68 yo M with a PMH significant for HLD, multiple sclerosis, vitamin B12 deficiency, rosacea, HTN, disorder or rotator cuff an lower back pain who had received Herpes Zoster (Shingles) Vaccine on 2/8/22 in right deltoid. Next day, patient developed generalized muscle pain. Patient reported "everything from neck down hurts, it started after shingles vaccine at clinic". Per EMR, the CDC RISKS OF VACCINE REACTION for Shingles was read to patient over the phone. He stated he was experiencing all of them (tired, muscle pain, feeling cold, decreased appetite. Unsure about fever since he had no thermometer). According to patient, "it hurt to even lay down". He states he took one 800mg Ibuprofen with minimal effect He was informed this could last 2-3 days per CDC vaccine info statement. Patient was instructed to continue to hydrate, take ibuprofen as needed and call back if symptoms became unbearable. No reports of patient received first dose of Shingles in August of 2021 and called clinic ~3 days later for c/o hypotension and decreased appetite for a couple weeks following vaccine administration. No further complaints were made thereafter.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: NARRATIVE: no information other than patient requesting exemption from Covid vaccine due to having a reaction to  the influenza vaccine
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash
Clinical narrative: Narrative: On 9/23/2021, patient reported to PCP had rash and swelling of throat after 2nd dose of COVID vaccine. No other information available regarding vaccine or administration.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Narrative: Pt has hx of recent abnormal menses after COVID vaccine. She had this occur after the vaccination course. Was placed on norethindrone for a short period of time and this resolved the issue. She recently received the booster and again had a repeat of irregular menses. She is needing a short course of norethindrone again. Please note that patient received all vaccine doses outside of facility. Exact timing of adverse event unknown, but system would not let me submit without entering a date in the event field.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills
Clinical narrative: Narrative: PATIENT REPORTED HAD CHEST PAIN AND CHILLS FOR ABOUT 8 HOURS AFTER FIRST DOSE OF THE MODERNA VACCINE.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swelling, Urticaria
Clinical narrative: Narrative:  PATIENT REPORTED THAT AFTER RECEIVING FIRST VACCINE SHE DEVELOPED HIVES OF FACE AND SWELLING AND TINGLING OF LIPS. SHE WAS GIVEN DIPHENHYDRAMINE AND MONITORED FOR 1.5 HOURS. SYMPTOMS RESOLVED AND SHE WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION ABOUT VACCINE AVAILABLE OTHER THAN WAS MODERNA.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Cardiac arrest, Cardio-respiratory arrest, Death
Clinical narrative: Narrative: Patient with history of CLL and COPD present to ER on 09/22/2021 unresponsive after 6 days of progressive shortness of breath. Patient coded, was intubated, and then admitted to ICU with diagnosis of acute hypoxic respiratory failure, status post cardiac arrest, and covid pneumonia. Patient extubated on 9/24/2021 and placed on comfort measures. Patient was DNAR. Patient died on 9/25/2021.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Intensive care, Post cardiac arrest syndrome, Unresponsive to stimuli
Clinical narrative: Narrative: Patient with history of CLL and COPD present to ER on 09/22/2021 unresponsive after 6 days of progressive shortness of breath. Patient coded, was intubated, and then admitted to ICU with diagnosis of acute hypoxic respiratory failure, status post cardiac arrest, and covid pneumonia. Patient extubated on 9/24/2021 and placed on comfort measures. Patient was DNAR. Patient died on 9/25/2021.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Narrative: historical - no available info
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Bell's palsy, Dysphagia, Headache, Hypoaesthesia, Paraesthesia oral
Clinical narrative: Narrative: Patient admitted to hospital on 11/7/2021 and reported HA, numbness of right side of face and perioral paresthesia and mild dysphagia. Diagnosed with Bell's Palsy. Unknown exact date of vaccine administration or other vaccine details.
Age: 55.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Lip swelling, Rash
Clinical narrative: Narrative: Patient reported lip swelling and rash over body about 18 hours after receiving both the pneumococcal and influenza vaccine.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis, Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Narrative: On PCP visit 1/29/2020, patient reported new dx with Guillian Barrre' syndrome; symptoms did not progress to the need for ventilator before intervention. He thought he had a sinus issue 2-3 days before, the day of admission he could not walk, L facial droop. Spinal tap + for GB, 5 bags IGG resolved many symptoms. Patient treated at hospital.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Sinus disorder
Clinical narrative: Narrative: On PCP visit 1/29/2020, patient reported new dx with Guillian Barrre' syndrome; symptoms did not progress to the need for ventilator before intervention. He thought he had a sinus issue 2-3 days before, the day of admission he could not walk, L facial droop. Spinal tap + for GB, 5 bags IGG resolved many symptoms. Patient treated at hospital.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Oropharyngeal pain, Pulmonary congestion
Clinical narrative: Narrative: PATIENT PRESENTED TO CLINC ON 9/20/2021 WITH C/O SOB, COUGHING, AND SORE THROAT X FEW DAYS. 02 SAT WAS 80% UPON TRIAGE. PMH INCLUDES HEP C WITH CIRRHOSIS, SCHIZOPHRENIA, COPD, AND POLYSUBSTANCE ABUSE. PATIENT TRANSFERRED TO ER AND WAS ADMITTED WITH DIAGNOSIS OF COVID INFECTION, PULMONARY VASUCLAR CONGESTION, HYPOXIC RESPIRATORY FAILURE, AND SEPSIS.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure, Sepsis
Clinical narrative: Narrative: PATIENT PRESENTED TO CLINC ON 9/20/2021 WITH C/O SOB, COUGHING, AND SORE THROAT X FEW DAYS. 02 SAT WAS 80% UPON TRIAGE. PMH INCLUDES HEP C WITH CIRRHOSIS, SCHIZOPHRENIA, COPD, AND POLYSUBSTANCE ABUSE. PATIENT TRANSFERRED TO ER AND WAS ADMITTED WITH DIAGNOSIS OF COVID INFECTION, PULMONARY VASUCLAR CONGESTION, HYPOXIC RESPIRATORY FAILURE, AND SEPSIS.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase increased, Blood creatinine increased, Blood glucose normal, Blood urea increased, Cough
Clinical narrative: Narrative: 71 year old Patient presented to the emergency department with complaint of nasal congestion, sinus drainage, cough and mild sob. She reported shortness of breath onset 2 to 3 weeks prior. 02 saturation 77% at triage. Sat improved to 90% on 4L O2. No history of asthma, COPD or any other lung problems. Troponin and D-Dimer elevated. Unable to perform CT with contract due to elevated serum creatinine ((2.38) Patient reported she had COVID vaccine booster on 11/23 or 11/24. Specific vaccine type and lot number not available in database for booster vaccine. Likely received outside our facility. Patient had previous history of DVT/PE in September 2020. Review of anticoagulation notes show that apixaban therapy was discontinue in February 2021. While in ED, patient became unresponsive. CPR initiated and patient intubated. Patient expired at 1831 on 11/26/2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Endotracheal intubation, Fibrin D dimer increased, Influenza virus test negative
Clinical narrative: Narrative: 71 year old Patient presented to the emergency department with complaint of nasal congestion, sinus drainage, cough and mild sob. She reported shortness of breath onset 2 to 3 weeks prior. 02 saturation 77% at triage. Sat improved to 90% on 4L O2. No history of asthma, COPD or any other lung problems. Troponin and D-Dimer elevated. Unable to perform CT with contract due to elevated serum creatinine ((2.38) Patient reported she had COVID vaccine booster on 11/23 or 11/24. Specific vaccine type and lot number not available in database for booster vaccine. Likely received outside our facility. Patient had previous history of DVT/PE in September 2020. Review of anticoagulation notes show that apixaban therapy was discontinue in February 2021. While in ED, patient became unresponsive. CPR initiated and patient intubated. Patient expired at 1831 on 11/26/2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Nasal congestion, Paranasal sinus hypersecretion, Resuscitation, SARS-CoV-2 test negative
Clinical narrative: Narrative: 71 year old Patient presented to the emergency department with complaint of nasal congestion, sinus drainage, cough and mild sob. She reported shortness of breath onset 2 to 3 weeks prior. 02 saturation 77% at triage. Sat improved to 90% on 4L O2. No history of asthma, COPD or any other lung problems. Troponin and D-Dimer elevated. Unable to perform CT with contract due to elevated serum creatinine ((2.38) Patient reported she had COVID vaccine booster on 11/23 or 11/24. Specific vaccine type and lot number not available in database for booster vaccine. Likely received outside our facility. Patient had previous history of DVT/PE in September 2020. Review of anticoagulation notes show that apixaban therapy was discontinue in February 2021. While in ED, patient became unresponsive. CPR initiated and patient intubated. Patient expired at 1831 on 11/26/2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased, Unresponsive to stimuli
Clinical narrative: Narrative: 71 year old Patient presented to the emergency department with complaint of nasal congestion, sinus drainage, cough and mild sob. She reported shortness of breath onset 2 to 3 weeks prior. 02 saturation 77% at triage. Sat improved to 90% on 4L O2. No history of asthma, COPD or any other lung problems. Troponin and D-Dimer elevated. Unable to perform CT with contract due to elevated serum creatinine ((2.38) Patient reported she had COVID vaccine booster on 11/23 or 11/24. Specific vaccine type and lot number not available in database for booster vaccine. Likely received outside our facility. Patient had previous history of DVT/PE in September 2020. Review of anticoagulation notes show that apixaban therapy was discontinue in February 2021. While in ED, patient became unresponsive. CPR initiated and patient intubated. Patient expired at 1831 on 11/26/2021.
Age: 79.0
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Narrative: historical- no information available
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Narrative:  Patient with anaphylactic reaction to covid vaccine at hospital. vaccine date/manufacturer not known. Pt required IM epinephrine, steroid burst and albuterol at hospital. exact doses not recorded in rapid access clinic note
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care
Clinical narrative: Narrative: Went to ER, admitted to ICU overnight.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Immunisation reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Narrative:  Pt had received a shingrix (recombinat zoster vaccine) on 2/10/22 in primary care clinic. PCC nurse had called pt to discuss labs on 2/15/22 when pt told nurse of adverse reaction from zoster vaccine of red, painful swelling in arm at injection site. Nurse advised pt to go to the ED for further evaluation. Pt had arrived to ED and was completely out of breath. Pt was treated with a combivent inhaler, oral benadryl and oral prednisone. Pt was given home Rxs to continue the oral benadryl and oral prednisone. Pt already has home albuterol inhaler Rx if needed for SOB. Primary care MD flagged pt's chart with ADR to zoster vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Beta-2 glycoprotein antibody negative, Blood immunoglobulin G normal, Blood immunoglobulin M, Cardiolipin antibody negative
Clinical narrative: Narrative: Upon review of her history, she was diagnosed with PE at hospital on 6/28, 18 days after her second Moderna vaccine (given on 6/19/21 at non hospital site). She was initially treated with heparin then apixaban, but had worsening symptoms despite no missed apixaban doses and switched to lovenox then bridged to warfarin on 7/4/21 and discharged on 7/6. She presented to hospital and admitted for PE 7/7/21 treated with fondaparinux bridging to warfarin. Prothrombin Gene and Factor V Leiden genes were both negative, and B2glycoprotein and Anticardiolipin Ig G an IgM antibodies were negative but additional hypercoagulability testing was not done.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: General symptom, Laboratory test normal, Prothrombin level normal, Pulmonary embolism
Clinical narrative: Narrative: Upon review of her history, she was diagnosed with PE at hospital on 6/28, 18 days after her second Moderna vaccine (given on 6/19/21 at non hospital site). She was initially treated with heparin then apixaban, but had worsening symptoms despite no missed apixaban doses and switched to lovenox then bridged to warfarin on 7/4/21 and discharged on 7/6. She presented to hospital and admitted for PE 7/7/21 treated with fondaparinux bridging to warfarin. Prothrombin Gene and Factor V Leiden genes were both negative, and B2glycoprotein and Anticardiolipin Ig G an IgM antibodies were negative but additional hypercoagulability testing was not done.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardioversion, Pulmonary embolism
Clinical narrative: Narrative: Patient has afib, and LLL multiple subsegmental PE that occurred in Nov 2021. The PE occurred about a week after cardioversion and admission to a hospital and about 10 days after a moderna covid booster.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Narrative:  Patient received the J&J covid vaccine on 4/2/21. He then got the Moderna vaccine 1/15/22. He presented to the ER with a stroke on 2/6/22. He has a history of prior CVAs in 2010 and 2015 and has been on rivaroxaban 20mg po daily since 1/10/20 (previously on warfarin before that since 3/2015).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Symptom recurrence, Urticaria
Clinical narrative: Both of my daughters are experiencing all over body rash involving hives that come and go all day long. Patient's was so bad and painful on 1/30/22 that she called MD and was prescribed 4 days of prednisone, Zyrtec and famotidine, which helped while taking them, but after treatment was done, all symptoms have returned.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Skin reaction, Urticaria
Clinical narrative: Delayed start all over body urticaria. Body rash is ongoing and weve just realized that same rash appeared last year not long after 2nd dose of Covid 19 Moderna and resolved on it's own after at least a month. Rash was and is frequently all over itchy and painful.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient came to office site to receive 2nd Covid vaccine. She completed consent form evaluated by nurse concerning consent form questions (Allergies, Health history) explained side possible side effects pt verbalized understanding administered vaccine IM/RA & advised pt to proceed next door to be monitored for 15 mins in which the pt started verbalizing she received previous vaccine a certain date which made her ineligiable to receive 2nd dose due to vaccine was given in error to soon (should have been 03/17/22) but info wasn't stated on consent form or vaccine card by registration person. Pt was then advised by a healthcare professional who monitored her that she would not received incentive card today because of this error and that she got could return om 03/17/2022 to obtain incentive card upon approval of staff. Pt Verbalized understanding and exited office in satisfactory condition with updated/correct vaccine care
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram head, Echocardiogram, Electrocardiogram, Lumbar puncture
Clinical narrative: Hospitalization Bell's palsy
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head
Clinical narrative: Hospitalization Bell's palsy
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body mass index, Body temperature, Body temperature decreased, Chills
Clinical narrative: Dry heaves; Nausea; Feeling Unwell; Stomach complaints; Chills; Low temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 02Mar2021 14:00 (Lot number: EN6202) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Abdominal Pain", start date: Apr2014, stop date: Oct2014, notes: Cholecystectomy 14May2014- Post operative digestive problems resolved over time; "Cholelithiasis", start date: Apr2014, stop date: Oct2014, notes: Cholecystectomy 14May2014- Post operative digestive problems resolved over time; "Cholecystitis", start date: Apr2014, stop date: Oct2014, notes: Cholecystectomy 14May2014- Post operative digestive problems resolved over time; "Stomach Inflammation", start date: 22Feb2017, stop date: 10Mar2017, notes: Right sided Pain endoscopy revealed stomach inflammation,; "Cholecystectomy", start date: 14May2014 (unspecified if ongoing), notes: Post operative digestive problems resolved over time; "Right sided Pain", start date: 22Feb2017, stop date: 10Mar2017, notes: Right sided Pain endoscopy revealed stomach inflammation,. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot- EN6201 , Anatomical site;Arm, ROA; Intramuscular, Time: 14:00), administration date: 09Feb2021, for Covid-19 Immunization. The following information was reported: BODY TEMPERATURE DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Low temperature"; RETCHING (non-serious) with onset 03Mar2021 02:00, outcome "recovered" (03Mar2021 07:00), described as "Dry heaves"; ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Stomach complaints"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Nausea"; MALAISE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Feeling Unwell". The event "dry heaves" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of retching.  Additional information: The right sided pain endoscopy was resolved with Pepcid for two weeks and elimination of spicy foods going forward. Anatomical site of administration was arm. The reporter concerned that the dosing amount for females with low BMI's was incorrect and caused this event and the patient reluctance to take the vaccine again. The patient felt like, had been Poisoned with the continuous dry heaves for 5 hours.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Nausea, Retching
Clinical narrative: Dry heaves; Nausea; Feeling Unwell; Stomach complaints; Chills; Low temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 02Mar2021 14:00 (Lot number: EN6202) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Abdominal Pain", start date: Apr2014, stop date: Oct2014, notes: Cholecystectomy 14May2014- Post operative digestive problems resolved over time; "Cholelithiasis", start date: Apr2014, stop date: Oct2014, notes: Cholecystectomy 14May2014- Post operative digestive problems resolved over time; "Cholecystitis", start date: Apr2014, stop date: Oct2014, notes: Cholecystectomy 14May2014- Post operative digestive problems resolved over time; "Stomach Inflammation", start date: 22Feb2017, stop date: 10Mar2017, notes: Right sided Pain endoscopy revealed stomach inflammation,; "Cholecystectomy", start date: 14May2014 (unspecified if ongoing), notes: Post operative digestive problems resolved over time; "Right sided Pain", start date: 22Feb2017, stop date: 10Mar2017, notes: Right sided Pain endoscopy revealed stomach inflammation,. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot- EN6201 , Anatomical site;Arm, ROA; Intramuscular, Time: 14:00), administration date: 09Feb2021, for Covid-19 Immunization. The following information was reported: BODY TEMPERATURE DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Low temperature"; RETCHING (non-serious) with onset 03Mar2021 02:00, outcome "recovered" (03Mar2021 07:00), described as "Dry heaves"; ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Stomach complaints"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Nausea"; MALAISE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Feeling Unwell". The event "dry heaves" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of retching.  Additional information: The right sided pain endoscopy was resolved with Pepcid for two weeks and elimination of spicy foods going forward. Anatomical site of administration was arm. The reporter concerned that the dosing amount for females with low BMI's was incorrect and caused this event and the patient reluctance to take the vaccine again. The patient felt like, had been Poisoned with the continuous dry heaves for 5 hours.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient felt abnormal (felt bad for a day), with outcome of unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected. This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain, Pain in extremity, Tinnitus
Clinical narrative: I was awakened at 4:21AM on March 5 with a piercing, shrill siren noise in my right ear. Eventually, over the course of a week, the intense shrill ringing traveled to also my left ear. Neither has subsided. It is interfering with my life. I originally reported this to VAERS:  VAERS ID: 1112025 E-Report Number: 365570 Date of Report: 03/18/2021 Date of Vaccination: 03/02/2021 Patient Age at Vaccination (years): 63.00  Also, beginning February 22, 2022 I have been having difficulty walking with shooting pain originating in my right leg, and migrating to left affecting both at the same time. Still painful. I will visit the ER as no physician is available.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Coccydynia
Clinical narrative: Tailbone pain and it has not gone away; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: EN6205) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Idiopathic urticaria" (unspecified if ongoing), notes: Verbatim: Idiopathic urticaria. The patient's concomitant medications were not reported. The following information was reported: COCCYDYNIA (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Tailbone pain and it has not gone away". Therapeutic measures were not taken as a result of coccydynia.  Additional Information: Consumer (Nurse) stated she had her COVID vaccine in March and she thought first dose and the second she got from, it was tailbone pain and it had not gone away. Experienced problem after second dose: Consumer stated No, the first dose. Consumer stated 22Mar2021, 2 hours after the vaccine. Consumer stated that she was still experiencing the event "Not elbow, 'toxic', It's 'toxic' and still persisting (Not clarified)." Causality: Consumer stated, "Has it caused it. she would say yes because she did not (voice not clear), yes the vaccine have cause it (Not clarified hence not checked)." The patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: ER2613) at the age of 40 years as dose 2, single for covid-19 immunization.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Taste disorder
Clinical narrative: About 15 minutes after receiving vaccine (was in the store for wait period) noticed the onset of a metal taste in my mouth. It started on the back right and moved over to the left and my tongue. There are patches on my tongue that don't work totally right; taste is messed up. Either things don't taste right or I can't taste them; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 at 11:30(at the age of 50-year-old) as a single dose for COVID-19 immunisation. The medical history included allergy to penicillin. It was reported that the patient's mother told her that as an infant they thought she had a reaction, so she avoided it. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included fish oil (MANUFACTURER UNKNOWN) and  women's multi-vitamin(unspecified), all from unknown dates and for unknown indications. On 03Apr2021 at 11:45, about 15 minutes after receiving vaccine (was in the store for wait period), the patient experienced the onset of a metal taste in her mouth. It started on the back right and moved over to the left and tongue. It was not super strong and kind of went away and came back intermittently throughout the day. It had been two weeks and it happened occasionally (at the time of report), but now her taste was messed up with onset Apr2021. Either, things did not taste right or she could not taste them - it was like there were patches on her tongue that did not work totally right with onset Apr2021. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metal taste in mouth was recovered with sequelae and stop date Apr2021, while that of taste was messed up did not taste right or could not taste and patches on the tongue was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: AE Stop Date/Time populated as Apr2021 per outcome Recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: My arm is swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Sep2021 10:15 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Elevated Cholesterol" (unspecified if ongoing), notes: Other medical history: Elevated Cholesterol. Concomitant medication(s) included: FINASTERIDE. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 05Sep2021 15:30, outcome "recovering", described as "My arm is swollen". Therapeutic measures were taken as a result of peripheral swelling.  Additional information: Consumer's arm was swollen on 05Sep2021, but was not swollen yesterday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of relaxation, Myalgia, Pain, Vaccination site pain
Clinical narrative: Muscles around injection site became sore/ Arm muscle pain; Muscles around injection site became sore; I was relaxed and tired; I was relaxed and tired; whole body ached so badly that just sitting there hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 17:15 (Lot number: EW0150) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "known allergies: apple skin, honey dew melon" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "known allergies: Amoxycillin" (unspecified if ongoing). Concomitant medication(s) included: LOESTRIN; XYZAL. The following information was reported: MYALGIA (non-serious) with onset 04Apr2021 05:00, outcome "recovered" (06Apr2021), described as "Muscles around injection site became sore/ Arm muscle pain"; VACCINATION SITE PAIN (non-serious) with onset 04Apr2021 05:00, outcome "recovered" (04Apr2021 16:00), described as "Muscles around injection site became sore"; FEELING OF RELAXATION (non-serious), FATIGUE (non-serious) all with onset 04Apr2021 05:00, outcome "recovered" and all described as "I was relaxed and tired"; PAIN (non-serious) with onset 04Apr2021 05:00, outcome "recovered" (04Apr2021 16:00), described as "whole body ached so badly that just sitting there hurt". Therapeutic measures were taken as a result of myalgia, vaccination site pain, pain.  Additional Information: Other medications in two weeks include multivitamin. The patient did not administer other vaccine in four weeks. The patient did not have Covid prior vaccination and was not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she just felt little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 11:10 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "she just felt little sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Coordination abnormal, Gait disturbance
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. A 70 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 13Feb2021 14:00 (Lot number: EM9809, Expiration Date: 30Jun2021) at the age of 70 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Verbatim: Diabetes" (ongoing); "Verbatim: Hypertension" (ongoing); "Verbatim: Cardiovascular disease, unspecified" (ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose received on 23Jan2021 in right deltoid., Lot: EK9231, Expiry: 30Apr2021, NDC: Unknown), administration date: 23Jan2021, when the patient was 69 years old, for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious) with onset 14Feb2021, outcome "recovered" (17Feb2021), described as "weakness/Felt weak"; GAIT DISTURBANCE (non-serious) with onset 14Feb2021, outcome "recovered" (17Feb2021), described as "had trouble in walking"; COORDINATION ABNORMAL (non-serious) with onset 14Feb2021, outcome "recovered" (17Feb2021), described as "uncoordinated like he was drunk which all lasted for 3 days". Additional Information: Calling about the Pfizer Covid-19 Vaccine. Caller stated that she had a patient who called and filed a report regarding adverse events he had to the 2nd dose of the vaccine. Patient reported that 12 hours after receiving the vaccine, which mean that the events began early in the morning on 14Feb2021. Patient felt weak, he had trouble walking and had to crawl at times to get up the stairs, and he felt uncoordinated like he was drunk. Events lasted for about 3 days. Events must have resolved on 17Feb2021. The patient did not seek medical treatment. It was reported by caller that the patient came into the office today and was eligible for the booster, when asked for seriousness criteria for the events, caller stated it was somewhere in between not serious and medically significant. Concomitant medications states that patient was on 14 medications and declines to provide any further details. No AE(s) required a visit to Emergency Room or Physician Office. AE(s) following prior vaccinations was reported as None. Family Medical History Relevant to AE reported as None. Relevant Tests was reported as None. Patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. Relatedness of drug to reaction(s)/event(s) for assessed reactions Felt weak, had trouble walking, felt uncoordinated like he was drunk was related. Source of assessment was Primary Source Reporter and Method of assessment was Global Introspection. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient), for a Pfizer sponsored program. A 74-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Feb 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), Jan 2021, single dose, for COVID-19 immunisation; reaction: shingles. The patient experienced pain in extremity (sore arms after the 2nd dose), with outcome of unknown. Follow-up (Nov 26, 2021): This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare, SARS-CoV-2 test
Clinical narrative: Granuloma Annulare; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 18Jan2021 (Lot number: EL9261) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (ongoing); "Depression" (ongoing); "Headaches" (ongoing); "Seasonal allergies" (ongoing). Concomitant medication(s) included: ALPRAZOLAM taken for anxiety (ongoing); ZOLOFT; GABAPENTIN taken for headache (ongoing); SERTRALINE taken for depression (ongoing). Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer, lot number= EJ1685, lot unknown= False, administration date= 28Dec2020, dose number= 1), administration date: 28Dec2020, when the patient was 51 years old, for Covid-19 Immunization. The following information was reported: GRANULOMA ANNULARE (non-serious) with onset 01Feb2021, outcome "not recovered", described as "Granuloma Annulare". The event "granuloma annulare" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of granuloma annulare. Additional information - It was reported that patient administered the vaccine at clinic and  anatomical site of vaccination was arm but unsure of Right or Left. The patient did not administer any other vaccination in four weeks and no  covid prior to vaccination. The patient underwent covid tested post vaccination. Patient also applied the Tacrilomus cream, Clobestol cream, ketolog cream as a treatment for the AE   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Amylase, Computerised tomogram, Feeling abnormal, Magnetic resonance imaging, Nervous system disorder
Clinical narrative: brain fog; neurological issues; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 30Jan2021 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "brain fog"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological issues". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient is family member to reporter, reporting of adverse reactions to the vaccine. states her family member received 2 doses of the Pfizer vaccine; her second dose was 20Feb2021 and after the first dose she had some brain fog but was tentatively ok. patient has had multiple CAT scans, X-Rays, blood work. Thought patient might have MS, clarified as Multiple Sclerosis. Patient put on Gabapentin, but unsure if it's helping or not. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. reporter stated patient was waiting to call her back regarding the neurological issues member is having as far as research medicine etc. did not go into detail regarding these issues.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: brain fog; neurological issues; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 30Jan2021 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "brain fog"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological issues". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient is family member to reporter, reporting of adverse reactions to the vaccine. states her family member received 2 doses of the Pfizer vaccine; her second dose was 20Feb2021 and after the first dose she had some brain fog but was tentatively ok. patient has had multiple CAT scans, X-Rays, blood work. Thought patient might have MS, clarified as Multiple Sclerosis. Patient put on Gabapentin, but unsure if it's helping or not. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. reporter stated patient was waiting to call her back regarding the neurological issues member is having as far as research medicine etc. did not go into detail regarding these issues.   No follow-up attempts are possible. No further information is expected.