chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; headache; muscle pain; fever; sweating; couldn't sleep; Felt sick; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 17th November 2019, the patient received the 2nd dose of Shingrix. On 17th November 2019, the dose was an unknown dose. In November 2019, less than a week after receiving Shingrix, the patient experienced tiredness, headache, muscle pain, fever, sweating, sleeplessness and feeling unwell. On an unknown date, the outcome of the tiredness, headache, muscle pain, fever, sweating, sleeplessness and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the tiredness, headache, muscle pain, fever, sweating, sleeplessness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: After vaccination with dose of Shingrix, the patient felt very tired, had bad headache, muscle pain, fever and sweting and trouble sleeping. The patient felt sick for 3 days. On 19th November 2019, the patient started feeling better. The reporter did not consent to follow up.
Systemic: looking pale-Mild, Additional Details: child was conscious all the time, parents chose not to go the hospital after EMS arrieved.
mom stated that pt started running fever that evening of 103; pt still had fever of 101-102 the next day on Saturday; still had fever on Sunday; mom took tp clinic; state the fever was from immun; mom stated local reactions on thigh;
I received my vaccine and returned to work. Around 3PM I started feeling chilly. But did not think much of it. At home, around 8-8:30PM I began to shake uncontrollably, I was shivering so hard my teeth were chattering. My body temperature was extreme hot to the touch and I experienced severe muscle soreness. My husband had to help me get dressed and undressed. I basically just slept or laid down for the most part and tried to keep myself hydrated. This lasted for about 1 1/2 days and then I woke up Sunday morning the 7th, totally fine. I still can see a little redness around the area of the injection site but nothing that someone else would think anything of it.
This spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 51-year-old, adult patient of unspecified gender. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. The patient did not experience any adverse reactions after vaccination. The reporter assessed this case as non-serious. This case (201805336) was cross-linked to original case 201805327 due to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (51-year-old) was added. The route of administration (intramuscular) and anatomical location (right deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
This case was reported by a healthcare professional (also the subject) and described the occurrence of joint pain in a 41-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included acid reflux, high blood pressure and right shoulder surgery. Concurrent medications included PROPRANOLOL, SEROQUEL, XANAX, HCTZ, NAPROSYN and NEXIUM. On 13 July 2010 at 13:30 the subject received 3rd dose of ENGERIX B (1 ml, unknown route, left arm). On 13 July 2010, approximately 3 hours after vaccination with ENGERIX B, the subject experienced joint pain and swelling. At 17:00 the subject experienced joint pain, and at 19:30 swelling occurred. The healthcare professional considered the events were disabling and life threatening. The subject was referred to the emergency room by her treating health clinic and was advised to take ibuprofen. At the time of reporting the events were unresolved.
Received vaccine 1:20 pm on 3/14/2021, That night experienced chills, headache,  fever and nausea.   Chills and headache throughout following day.  Fever broke after taking Tylenol.  Not allowed back to work for 48 hrs after shot due to adverse effects,
1 day post vax pt devel soreness & tenderness in rt arm;devel temp-rash around inj site rt arm-red, inflamed;inc temp 105;dx cellulitis;ATB/antiviral med;
The day after the injection, patient reported arm soreness, resulting in a welt below the site of the injection. The day after the injection, the patient also reported mild nausea, tiredness, appetite loss that is still ongoing.
Nausea, vomiting  and diarrhea. Chronic diarrhea with negative stool studies.
most of the dose was not administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of underdose in a 12-month-old male patient who received HAV (Havrix) for prophylaxis.   On 26-SEP-2023, the patient received the 1st dose of Havrix (unknown thigh). On 26-SEP-2023, an unknown time after receiving Havrix, the patient experienced underdose (Verbatim: most of the dose was not administered).  The outcome of the underdose was unknown.   Additional Information: GSK receipt date: 26-SEP-2023 The nurse manager reached out to ask about redose for 12-month-old male patient after Havrix vaccine error.  The needle broke (no other information given), and most of the dose was not administered. The most dose was not administered which led to underdose. The reporter did not consent to follow up.
Pt started experiencing extreme vertigo 14 days after 2nd dose of vaccine. There were no new onset diseases diagnosed or new medications started within this period. She went to ER and MD visit for care. MD visit diagnosed her with benign paroxysmal positional vertigo. She is still having episodes that are treated with meclizine.
Pericarditis with chest pain, fever.  Treated with colchicine and improved after 2 days
This spontaneous report as received from a pharmacist refers to a patient (age, sex unknown). The patient was vaccinated with PNEUMOVAX 23 (lot # 669379/0453AA, expired date 03-AUG-2012) on 19-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
4-5 days later, I noticed my motor skills are slow/getting up from bed is difficult; Walking difficulty; Leg discomfort; She is experiencing pain in her joints, knees, and elbows; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (4-5 days later, I noticed my motor skills are slow/getting up from bed is difficult), GAIT DISTURBANCE (Walking difficulty), LIMB DISCOMFORT (Leg discomfort) and ARTHRALGIA (She is experiencing pain in her joints, knees, and elbows) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN HCTZ), LEVOTHYROXINE, MULTIVITAMIN [VITAMINS NOS], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced MOBILITY DECREASED (4-5 days later, I noticed my motor skills are slow/getting up from bed is difficult), GAIT DISTURBANCE (Walking difficulty), LIMB DISCOMFORT (Leg discomfort) and ARTHRALGIA (She is experiencing pain in her joints, knees, and elbows). At the time of the report, MOBILITY DECREASED (4-5 days later, I noticed my motor skills are slow/getting up from bed is difficult), GAIT DISTURBANCE (Walking difficulty), LIMB DISCOMFORT (Leg discomfort) and ARTHRALGIA (She is experiencing pain in her joints, knees, and elbows) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment was not specified.   This case was linked to MOD-2021-275275 (Patient Link).
Confusion, my ear got very swollen - it had hives and bumps on it and was itchy. I saw my doctor the next day. I got two antibiotics shot. I also started on antibiotics and this helped with the symptoms. It took about a week and a half for symptoms to resolve.
Irritable & crying uncontrollably 2 1/2 hr after vaccine until 5-6 hrs later. Then 101.5 fever.
Spoke with donor on 08-13-08, donor stated that she vomited approximately 8 oz the night of injection. Donor also states she has pain at injection site with swelling.
Seventy-two hours post vax, pt started getting short of breath with wheezing. He states he had a similar reaction to the flu vax.  Pt was admitted to rule out myocardial infarction. He was dx in hospital with a sinus infection.
Cardiac magnetic resonance (CMR)-proven myocarditis shortly after vaccination; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Cardiac magnetic resonance (CMR)-proven myocarditis shortly after vaccination) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Cardiac magnetic resonance (CMR)-proven myocarditis shortly after vaccination) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Cardiac magnetic resonance (CMR)-proven myocarditis shortly after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ejection fraction (Unknown-> 55%): 58% (normal) 58%. In 2021, Electrocardiogram: abnormal (abnormal) Sinus rhythm with diffuse ST elevation. In 2021, Magnetic resonance imaging heart: abnormal (abnormal) Short-axis views demonstrating increased T2 signal and LGE in the mid wall and subepicardial layer of the mid-posterolateral segment in a patient who received their second SARS-CoV-2 vaccination 6 days earlier. In 2021, SARS-CoV-2 test: negative (Negative) Patient had negative nasopharyngeal SARS-CoV-2 PCR testing. In 2021, Troponin I: 18.94 ng/ml 18.94 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Cardiac magnetic resonance (CMR)-proven myocarditis shortly after vaccination) to be possibly related.    Concomitant medications were not provided.  No treatment information was provided.  Patient was within the age range 20-25 years, previously healthy with no infectious prodrome.  The symptoms of the patient at presentation included pleuritic and positional chest pain, chills, myalgias, and subjective fever. Patient did not develop any other complications.  Author concluded that although the clinical presentation, CMR findings, and temporal association strongly suggest the possibility of vaccine associated myocarditis in our 6 patients, we cannot conclude definitively that COVID-19 vaccine was causative or that other etiologies for myocarditis can be definitively excluded in our patients. Nevertheless, clinicians should be suspicious of myocarditis in recently vaccinated patients with symptoms consistent with this diagnosis.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
received fluzone high-dose quadrivalent at her local drug store and was told later by the drug store that her dose had been in a warm temperature excursion with no adverse event; received fluzone high-dose quadrivalent at her local drug store and was told later by the drug store that her dose had been in a warm temperature excursion with no adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional).  This case involves an unknown age female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] at her local drug store and was told later by the drug store that her dose had been in a warm temperature excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Oct-2022 , the patient received a 0.7 ml total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength, and lot number: unknown) via unknown route in unknown administration site for immunization.  On 25-Oct-2022 the patient received Fluzone high-dose quadrivalent at her local drug store and was told later by the drug store that her dose had been in a warm temperature excursion with no adverse event (product storage error) (poor quality product administered) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
rash on her upper arms and legs; itchy rash on her upper arms and itchy rash on her legs; This is a spontaneous report from a contactable consumer (reported for herself). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 06Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the consumer reported that, she received her second shot on 06Mar2021 had no problems with either the first shot or the second shot. The consumer reported that about a week after receiving the second shot, she developed a itchy rash on her upper arms and itchy rash on her legs. Any reports of this happening a week after the shot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
15 dose vial thawed only for 30 minutes before administration left out to thaw at room temperature for only 30 minutes, instead of 1 hour and 30minutes; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PREPARATION ERROR (15 dose vial thawed only for 30 minutes before administration left out to thaw at room temperature for only 30 minutes, instead of 1 hour and 30minutes) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced PRODUCT PREPARATION ERROR (15 dose vial thawed only for 30 minutes before administration left out to thaw at room temperature for only 30 minutes, instead of 1 hour and 30minutes). On 15-Sep-2021, PRODUCT PREPARATION ERROR (15 dose vial thawed only for 30 minutes before administration left out to thaw at room temperature for only 30 minutes, instead of 1 hour and 30minutes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment received  by the patient. The  vial was removed from the freezer at 9:30am on 15sep2021.The patient has not reported any side effects.
smelling sensation that resembles the smell of deep heating a sore muscle with a rub, the smelling sensation is present all the time and it seems to be getting stronger; dry cough; This is a spontaneous report from a contactable consumer (patient) via RA. A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8733, expiration date was not reported) via an unspecified route of administration, in right arm, on 25Mar2021 (at the age of 69-year-old), at dose 2, single for covid-19 immunization from hospital. Medical history included rotator cuff problems in his left arm. Concomitant medication included cortisone taken for rotator cuff problem in his left arm, about a week and a half ago. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6205, expiration date was not reported) via an unspecified route of administration, in left arm, on 03Mar2021, at dose 1, single for covid-19 immunization and flu shot (INFLUENZA VACCINE) on Nov2020 (two years ago) and experienced cough, runny nose, and chills. The patient experienced dry cough on 25Mar2021, and it only lasted for a few hours. On 28Mar2021, the patient had a smelling sensation that resembles the smell of deep heating a sore muscle with a rub; it smells like when applied a deep heat to a sore muscle and it is present all the time and getting stronger. There were no investigation assessments. The outcome of the event dry cough was recovered on 26Mar2021 and the other event was not recovered.  No follow up attempts are possible. No further information is expected.
I am pretty sure this isn't related to the vaccine. On Monday, 9/27/2021, I noticed that my right shin was red. On Tuesday, my lower leg was very swollen and very red. I thought it might be cellulitis. I called to make an appointment with my primary care doctor and was told to go to Urgent Care or the Emergency Room to rule out a blood clot or major infection. I went to Urgent Care. The PA who examined me was very concerned that it had swelled so much overnight and sent me to the emergency room for what he anticipated would need antibiotics. I traveled to the emergency room where I had an ultrasound, and blood test to rule out other issues and was sent home with a prescription for Cephalexin 500 mg, 4x daily. After a few days of elevation and the antibiotic, the swelling went down and the cellulitis went away. On 10/1/2021 I went to my new primary care doctor who replaced my original primary care doctor who retired the day before. He said it was cellulitis but was better and to continue with the treatment until the medication was finished.
Client called for test results and commented that "My arms felt weak for two weeks". "After I gave you your shots?" I asked? "Yea, it felt like I had been fishing hard" - which to me means, as a fisherman, his arms felt overworked, tired, sore, limited range of movement. Client told me he was improved now. No symptoms.
It was reported by the Sheriff's Dept. that patient was found expired on 4/13/21 - sitter reported that patient went to take a nap and the sitter went to check on him and found him unresponsive and called 911; patient was DOA on arrival
3cm x 3cm (as measured by physician localized redness and swelling; fever and body aches; treated by BENADRYL and NSAIDS (ibuprofen).
A non-serious spontaneous report of 23-month-old male received H1N1 LAIV and fever of 103 F has been received from a physician, subsequent to H1N1, Intranasal vaccination. The patient had no medical history and no concomitant medication was taken by the patient. The child had already received the injectable vaccine for the H1N1 and did well. On 30-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 30-Oct-2009, after vaccination the patient experienced sharp spike in fever of 103 F, which resolved 24-hours later on 31-Oct-2009. The outcome of reported events was resolved. Additional information was received on 04-Dec-2009 and incorporated into the narrative: Information added in medical history, concomitant medication and event description changed.
This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: RHINORRHOEA (non-serious) with onset 29Mar2021, outcome "unknown", described as "runny nose"; NASOPHARYNGITIS (non-serious) with onset 29Mar2021, outcome "unknown", described as "colds". Additional information: Caller was scheduled to have her second dose today (29Mar2021). She has no fever but she was experiencing runny nose. Her daughter had a cold last week that's why she was about to have it as well. Wanted to know if she still needed to get the second dose. She forgot the exact date for her first dose but it was in the 1st week of March. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reports chest tightness and difficulty taking deep breaths, starting on 9/12/21.
Shot received @ 9:45 am, normal arm tenderness started around 8 pm and continued through to the next day. The next day around 3 pm I started having pain in my left arm pit and the underneath of my arm in the injection area,  by 9pm that night (day after receiving shot) the pain in my arm pit was so bad it hurt to lift my arm or lay one it. the following day Friday the 12th the pain continued in my left armpit and underneath of my arm. It was extremely painful to touch. My Saturday March 13th the pain had started to shift to the lower part of my arm pit and into the side of my left breast. On Sunday the 14th the pain in my breast was gone and I finally felt like I could lift my arm and sleep on it, It was just tender to the touch. Now it is tender to touch in the center of my armpit and the underneath of my arm from arm pit to elbow.
Erythema & bruising present at rt. upper arm. Area feels warm to touch. Patient notes discomfort at 3/10. She has taken Ibuprofen for pain. Cellulitis present. Cephalexin 500mg one two times daily x 10 days.