chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received expired vaccine administered >12/ hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine administered >12/ hours post puncture) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine administered >12/ hours post puncture). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine administered >12/ hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-414692 (Patient Link).
tested positive for COVID; positive for COVID; positive for COVID/asymptomatic; This is a spontaneous report from a contactable nurse reporting for herself.   A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on 18Dec2020 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.   She was tested positive for COVID, through the rapid COVID test on 27Dec2020. She stated being asymptomatic and being scheduled for her 2nd dose on 08Jan2021. She asked can she still receive the 2nd dose of the vaccine or should she repeat the vaccination series. The outcome of event was unknown.    Information on the Lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with suspected vaccine in this patient cannot be completely excluded.  Further information like confirmative COVID 19 Nucleic acid/ PCR test are needed for full medical assessment.
pain under the right armpit; Swelling; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 (Lot number: FF2587) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 16Apr2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 24Mar2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Dose number 3"; AXILLARY PAIN (non-serious) with onset 16Dec2021, outcome "recovered" (Dec2021), described as "pain under the right armpit"; SWELLING (non-serious) with onset 16Dec2021, outcome "recovered" (Dec2021), described as "Swelling". Therapeutic measures were not taken as a result of axillary pain, swelling.  Additional information: The patient had no known allergies. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
injection site it's hot; injection site very itchy; injection site a little swollen; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE WARMTH (injection site it's hot), INJECTION SITE PRURITUS (injection site very itchy) and INJECTION SITE SWELLING (injection site a little swollen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A), and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced INJECTION SITE WARMTH (injection site it's hot), INJECTION SITE PRURITUS (injection site very itchy) and INJECTION SITE SWELLING (injection site a little swollen). At the time of the report, INJECTION SITE WARMTH (injection site it's hot), INJECTION SITE PRURITUS (injection site very itchy) and INJECTION SITE SWELLING (injection site a little swollen) outcome was unknown.
administered after the expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-month-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent) (batch number 2E43L, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2022, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On 1st July 2022, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JULY-2022 Reporter's comment: The reporter stated that Flulaval was administered to a patient after the expiration date. Reporter consented to follow up. Additional supportive narrative: As patient administered expired vaccine which led to expired vaccine used.
6-7 minutes after injection, thumping on neck main vein (left-side) rapid like Morse code; watery eyes like crying, sweating  profusely,  very hot needed aire; notified the pharmacy immediately, water was given and waiting 1/2 hour after injection; first day headache and tired; next 2-4 days, lethargic, sick, throwing up, sleepy, location of the injection red/pink color grow from a quarter size to larger than .50 cent piece, gone after day 5, no sore right arm never had soreness, later that day and evening difficult sleeping ache joints, muscle from head to toe took Advil PM to get sleep; day 6 (Nov 9th, 2021) scratchy throat, like throat closing, body aches, throat sore and difficult to talk; day 7 very sore throat talking difficulty and becoming congestion in sinsus symptoms, was not able to breathe thru nose, breathing from mouth very cold hear, sinsus congestion for 2-3 days; called sever sinsus infection spitting up yellowish grey from sinus and difficulty breathing brochicitus, having other adverse reactions after injection, family and coworkers were worried, thru November 29, 2021 fatigued and now having chronic cough dry throat due the Johnson Johnson vaccinations. A total of 25 days for recovery or feeling back to normal.
shortness of breath/breathing wasn't easy and was not able to fill their lung; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/breathing wasn't easy and was not able to fill their lung) and PYREXIA (fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 003C21A) for COVID-19 vaccination.     Concomitant products included TELMISARTAN (TELMIKIND) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced DYSPNOEA (shortness of breath/breathing wasn't easy and was not able to fill their lung) and PYREXIA (fever). At the time of the report, DYSPNOEA (shortness of breath/breathing wasn't easy and was not able to fill their lung) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, Body temperature: 101 (Inconclusive) Inconclusive.         On 22-May-2021, the patient had a fever of 101 for which the patient took paracetamol. He started having shortness of breath on the evening of 22-May-2021.  He reported that his breathing wasn't easy and he was not able to fill his lung.  The patient went to an Urgent Care on 23-May-2021 and was prescribed cetirizine and benzonatate 10 mg. At the time of the report, his symptoms are not as strong but were still present.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: FU Received on 24-May-2021.Expiration Date(second dose): 10/23; 10/17/2021 (first dose) were updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Patient is a very pleasant 83-year-old female patient of Dr. with medical history significant for coronary artery disease, previous history of CABG, paroxysmal atrial fibrillation on chronic anticoagulation with Coumadin, previous history of ablation, previous history of breast cancer and mastectomy in 1994, sick sinus syndrome history of pacemaker, previous history of seizure disorder, valvular heart disease, previous history of aortic valve replacement surgery in May 2018, history of GI bleed admitted for the above reason. As per the history obtained from the chart and also from the patient.  Patient has been brought to the emergency room yesterday because patient has been feeling increasing generalized COVID-19, per patient's daughter patient was diagnosed approximately 6 weeks ago - received regeneron, chest x-ray with multifocal infiltrates however clinical picture more consistent with a CHF exacerbation, will start patient on empiric steroid, zinc/Ascorbic acid, consult infectious disease
4x6 inch, redness, swelling, sore arm. Pt went to ER on 10/15/2011. Dr put her on antibiotics. Said she had cellulitis.
About 5 minutes after receiving the vaccine, he walked up to the in window stating that he felt his vision was diminishing. Then immediately he swayed and fainted. He came around quickly and paramedics were called.  The paramedics assessed him and left without  transporting him.
Patient presented in office 2-27-08 for ADHD visit with concerns about weight loss.  He was healthy and afebrile.  He received # 2 VZV vaccine into his right upper arm.  On 2-28-08 he presented in office with moderate edema and localized area of puffy erythema, 3 x 5 cm, with mild tenderness. His temp was 97, orally.  Ibuprofen and cool compresses were recommended with follow up if not improving.
Right away bad pain in arm, about an hour after I developed a metallic taste in mouth. Next day, injection site is very swollen, headache, tired and metallic taste remains.
Information has been received from a health professional concerning a 21 year old female with a history of papanicolaou smear abnormal and hypersensitivity to latex, peaches, blue dye, and green dye, who on 25-Oct-2007 was vaccinated intramuscularly with her first dose of Gardasil (lot #658563/1063U).  Concomitant therapy included CLINDAMYCIN PHOSPHATE (Klindan (clindamycin phosphate)) and ethinyl estradiol/norgestimate (SPRINTEC).  On 27-Oct-2007 the patient experienced an unspecified rash.  The patient contacted the office by phone and no details about the rash were provided.  The patient was not examined in the office and no treatment was required.  No further details available.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow up information has been received from a Registered Nurse (RN) concerning a 21 (reported as "20" year old in follow up) year old white female student with a history of papanicolaou smear abnormal and hypersensitivity to latex, peaches, blue dye, and green dye, who on 25-OCT-2007 at 03:00 PM was vaccinated intramuscularly into right deltoid with her first dose of GARDASIL (Lot # 650563/1063U). Concomitant therapy included KLINDAN and SPRINTEC. On 27-OCT-2007 the patient experienced an unspecified rash. The patient contacted the office by phone and no details about the rash were  provided. The patient was not examined in the office and no treatment was required. No further details available. In follow up it was reported that on 05-NOV-2007 a follow up phone call was made to discuss how long the rash lasted. No response from patient was available at the time of this report. The outcome was unknown. Additional information is not expected.
Red itchy patch on LT with  no pain. provider prescribed  Benadryl 12.5mgl/5ml 2.5 ml  PO Q4-6hrs prn.
Loss of sensation in legs/lost feeling in both of their legs; left leg was still numb; This spontaneous case was reported by a consumer and describes the occurrence of SENSORY LOSS (Loss of sensation in legs/lost feeling in both of their legs) and HYPOAESTHESIA (left leg was still numb) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced SENSORY LOSS (Loss of sensation in legs/lost feeling in both of their legs) and HYPOAESTHESIA (left leg was still numb). At the time of the report, SENSORY LOSS (Loss of sensation in legs/lost feeling in both of their legs) and HYPOAESTHESIA (left leg was still numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
[Pfizer COVID vaccine] use for COVID-19 under Emergency Use Authorization (EUA):Patient presented at clinic to PCP for 1st dose Pfizer vaccine. 20 minutes after administration she started experiencing tingling of mouth, throat tightness, hoarse voice and coughing. She received 1 dose of EpiPen 0.3mg and placed on oxygen at 2.5L/min and taken to ED for assessment.
DTaP, IPV, HIB, PREVNAR given at 0900. Pt was very difficult to console until early evening, refused bottle until late afternoon.
Shortly after receiving the vaccination, she indicated that he left side of her neck felt number and upon assessment by another provider, her left tonsil reportedly appeared swollen. She was experiencing tightness in her throat. A provider on site ordered 62.5 mg Solumedrol IM one time which was administered. All symptoms resolved with the exception of a slight residual headache.
BODY ACHE; CHILLS; NAUSEA; HEADACHE; FEVER; SORENESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced soreness. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced nausea. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced body ache. On 21-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the soreness, chills, headache, fever, nausea and body ache was not reported. This report was non-serious.
Right facial swelling/angioedema of the right face (same side as injection).  Treated with cetirizine 20mg po x 1 and prednisone 40 mg po x 1 in the emergency department.  Patient discharged with prednisone to taper 40mg to 10mg and cetirizine 10mg bid until 1/22/2021.
Person who did vaccination stood between percipient and the percipient's left arm and squeezed the arm very tight.  Then the person who gave the shot jammed the needle into the arm so hard that I could feel the needle go through  all the muscle tissue in that arm.  This was extremely painful and it created a knot in the muscle about the size of a large golf ball.  I can still feel the knot today.   For two days afterward it was very tender and hot.  Now there is only the knot.  The person who gave the shot said that she checked with the pharmacist and that he told her that I should take only Tylenol.  She brought me extra strength Tylenol.  Those two actions say to me that she knew that she had done something wrong and had hurt me.
This spontaneous report as received from an unspecified healthcare worker refers to a 14 year old patient. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 17-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, Lot# L000610 with expiration date 31-JAN-2017, Current Procedural Terminology (CPT) 90651 (dose and route of administration were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Pt reports on 4/13/18 his bicep began to swell. (LA) it was red and swollen. The bicep was stiff and ROM was limited. Pt was advised to go to ED, but declined.
Nauseated shortly after the shot, lips started swelling after about 30 minutes. Tongue swelling on (R) side, went to sleep about 6-7 pm woke up around tongue still swollen, increased swelling of tongue, around inj. site and left wrist. To ED around 11 pm.
pt recvd vax 15OCT93 & exp h/a, lt arm pain, AM lt eye tearing got worse-progressed to where face felt like a xylocaine shot; dx bells palsey;
The nurse gave me an injection into my left deltoid but after pushing the syringe and removing the needle she stated "I'm unsure if I had any vaccine in that shot.  No I'm almost positive I didn't have any, it just didn't push right. Oh well, we will just give you another one."  I asked if she was sure in which she stated "yes I'm fairly certain I didn't have any vaccine in there.  You only got this much (pointing to the syringe) of air so it will be fine.  We will just give you another one."  I asked if she was sure that that would be ok, in case I did get vaccine in the injection.  She reassured me again and stated that it would be fine.  On Monday evening I felt "off" and felt like my heart was beating faster than normal but went to bed.  In the morning I felt better so went to the gym as I do most days of the week at 5am.  During class I felt a slight burn in my chest but it went away fairly quickly.  On the way home from the gym I noticed that my heart rate was note returning to baseline as quickly as it normally would and noticed on my apple watch that my HR was between 120-130bpm.  I started feeling sick and dizzy and got really sweaty.  I also started to feel like I was going to pass out so I pulled over and called my husband for reassurance.  During our phone call I felt sick and ended up throwing up.  Afterwards I started to feel well enough to drive the rest of the way home.  While getting ready for work I noticed that my heart rate was still above it's normal and was between 100-120bpm.  I called my local PCP who recommended that I present to the ER.  While at the ER my heart rate was slowly returning to baseline.  No abnormalities were observed on the EKG and all labs were normal except an elevated troponin of 50.  Due to the elevated troponin I was admitted to the hospital for observation and was in the hospital from 12/14-12/16.  My discharge diagnosis was Minoca and I am still undergoing testing.
Presented with SOB and CP for months, History of Covid PNA on 8/8. Admitted with Covid PNA. Treated with antibiotics, steroids, O2. Discharge home
lungs filled up with fluid; trouble breathing; This case was reported by a consumer via interactive digital media and described the occurrence of pulmonary edema in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   In November 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, the patient received COVID-19 VACCINE. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pulmonary edema (serious criteria hospitalization and GSK medically significant) and difficulty breathing. On an unknown date, the outcome of the pulmonary edema and difficulty breathing were unknown.   It was unknown if the reporter considered the pulmonary edema and difficulty breathing to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the flu shot and have had trouble breathing ever since then.  The patient's lungs filled up with fluid and he/she had to go to the hospital. Till the time of reporting, the patient still seeing a lung doctor.  The patient said that, no more poison for him/her.  The patient reported that, they were no longer giving vaccines, but experimental drugs with MRA in them that destroy your immune system, wake up people. It was unknown if the reporter considered the pulmonary edema and difficulty breathing to be related to Covid vaccine. The follow-up would not possible as no contact details were available. Note: It was unknown if the patient had received Covid vaccine or not, as it was mentioned in source document under product field, hence conservatively captured as suspect. The clarification has been raised for the same.
Employee reported to COVID vaccine clinic for 2nd dose of vaccine. 2 nurses were working together to complete admin paperwork and the other to give the shot. The vaccine administrator administered the shot before the screen for triage was completed. Upon entry of triage, it was discovered the team member was only on day 14 post vaccination from dose 1. No adverse reaction.
EXTREME PAIN STARTED IMMEDIATELY. COULDN'T MOVE ARM BY THE NEXT DAY. RANGE OF MOTION IS AFFECTED.
Symptoms started about 5 to 6 weeks after 2 dose. I strongly believe that the following Symptoms are due to receiving the vaccine: Nausea, vomiting, stomach pain
About 12 hours after getting the second Moderna dose, while trying to sleep, my heart rate was 100-110, with the feeling of repeated PVCs in my heart.  I knew this feeling because I had dealt with episodes of repeated PVCs (and later PACs) from about 2016 to February 2020.  After being in the hospital in February 2020 for life-threatening sepsis, pneumonia, and strep, the arrhythmias stopped completely.  I had been trying to control the episodes by taking atenolol 25mg/d; upon realizing that the PVC episodes had stopped, I terminated the medication.  So at about 1AM on 3/7/2021 or so, I noticed the PVCs and the rapid heart rate and could not sleep.  Fever went up to 102.4, thirsty and possibly dehydrated. Went to ER at 7am.  Tests showed repeated PVCs.  Kidney function was slightly abnormal.  Started taking atenolol through Tuesday, 3/9.  Heart monitor halter showed PVCs continued through Tuesday.  By Thursday, 3/11, it was apparent that the PVCs had stopped and heart rate was normal.  I stopped the atenolol and the irregular heartbeat has not returned.