chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost of smell; sore throat; cough; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost of smell), OROPHARYNGEAL PAIN (sore throat), COUGH (cough) and MYALGIA (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 since 22-Jan-2021.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced ANOSMIA (lost of smell), OROPHARYNGEAL PAIN (sore throat), COUGH (cough) and MYALGIA (Body ache). At the time of the report, ANOSMIA (lost of smell), OROPHARYNGEAL PAIN (sore throat), COUGH (cough) and MYALGIA (Body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Shingles outbreak (day 8), swollen lymph nodes, arm numbness, arm pain, swollen warm rash near injection site getting worse on day 9 now. Fatigue, headache, joint pain, rash around fingers and wrist. Need antibiotics for infection caused by injection.
Whole upper Right arm swollen and very itchy and pain with touch since date of vaccine 3/29/2018. Swelling decrease in two days.
G2, P1. 21 weeks 2 days at time of vaccination, due 5/19/20. Est fetal weight approx. 15.7ounces as of 1/6/20.   Mild arm soreness, onset approximately 5 hours after vaccine. Subsided within 36 hours.
pt recv vax & became pregnant & pt had a miscarriage;No further details are expected;
Case number PHEH2014US009390, is an initial spontaneous report received from medical assistant on 05 May 2014. This report refers to 13 year old female child. She was vaccinated with MENVEO (batch number: M12103, expiry date: Sep 2014) 0.5 ml intramuscular on 05 May 2014. It was reported that the unreconstituted MENVEO reached 33.8 degree Fahrenheit for 8 hours and 31 minutes. No adverse event was reported following this mal administration.
pt recv vax 22SEP97 & 18NOV97 pt dx w/a mild case of chickenpox w/a total of 7 pox;
PATIENT FAINTED 1O MINUTES AFTER VACCINE. SHE FELT LIKE SHE WAS ABOUT TO PASS OUT BEFORE WALKING TO THE COUNTER, AT WHICH POINT SHE FAINTED.  PATIENT WAS OUT FOR ABOUT 5-15 SECONDS. WE MOVED THE PATIENT TO A CHAIR UPON WAKENING, GAVE HER WATER AND COKE. NO OTHER TREATMENT WAS NECESSARY. SHE REMAINED IN THE STORE FOR 45 MINUTES, BEFORE RELEASING THE PATIENT
died because of the vaccine; This is a spontaneous report from a Non-contactable consumer (patient's grandson). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died because of the vaccine on an unspecified date. The cause of death was not reported. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died because of the vaccine
Feel terrible; Chills; Arm is very tender; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel terrible), VACCINATION SITE PAIN (Arm is very tender) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm is very tender). On 09-Jan-2021, the patient experienced FEELING ABNORMAL (Feel terrible) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Feel terrible), VACCINATION SITE PAIN (Arm is very tender) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.  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.; 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.
Headache, dizziness, nausea, fatigue, arm soreness, injection site redness.
Client stated that she started having itchiness and redness early in the morning on 9/15/05 on her arms, torso, back, upper legs extended to her groin areas. Client phoned her PMD. Client was told to take Benadryl and not to receive Hep A #2.
Macule papular red rash on neck, head, face, arms, chest. Swollen hands, fever.; Clinical  course of development 27 hours after injection.
Noted that symptoms began about 1 week after second dose of Pfizer COVID-19 vaccine. Symptoms initially started with moderate hot flashes, constant migraine headache.  Symptoms progressed to substernal chest pain that is somewhat positional however now has become constant.  Pain radiation to right neck.  Noticed decreased exercise tolerance such as walking moderate distances made her extremely sweaty.   Went to ER on 6/29/21 after first being seen by primary doctor and found of ST depressions and was found abnormal EKG, normal D-dimer, troponin negative, placed in the rapid cardiology follow-up list.    Went to ER on 7/4/2021 due to ongoing symptoms that are sharp, substernal, constant, worsened with bending over, intermittently radiating to right neck.  Family history of MIs in the 40s.  Patient does not smoke.  Not a diabetic. New onset of right crampy groin pain and right calf pain.  No history of DVT personally.  Diagnosis in ER: Given the patient's clinical history, character and duration of symptoms, I am more suspicious for pericarditic equivalent rather than primary ACS. Recommend ibuprofen 400 mg 3 times a day.  X10 days. We will arrange outpatient echocardiogram Once all symptoms are resolved may be in 3 to 4 weeks consider stress testing Will arrange follow-up in the office within a week DC planning from cardiac standpoint.
Headache, fatigue, body aches, L deltoid area hot, swollen, tender and redness was 7x8 cm; this was about 2 cm below the injection site. After 3 days, ecchymoses noted at injection site. Redness continues but headache lasted only several hours.
Nausea at the 8th min, reported feelings of anxiety; monitored , acknowledged, empathized, and cool compress cloths. Resolved in 24 minutes after nursing empathy.
no adverse event; Vaccine that was expired on 20Jun2021 was administered to 4 patients on 22Jun2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that was expired on 20Jun2021 was administered to 4 patients on 22Jun2021) and NO ADVERSE EVENT (no adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that was expired on 20Jun2021 was administered to 4 patients on 22Jun2021). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that was expired on 20Jun2021 was administered to 4 patients on 22Jun2021) had resolved and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. no treatment medication provided.  It was reported that there was no adverse events/adverse outcomes resulted from this expired Moderna during their second vaccinations.   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2021: follow up document received on 16-08-21 with new information.
Onset of temp of 103 F for > 24 hours. On 06/05/02 c/o not eating, not drinking, decrease in activity. pt seen in clinic 06/06/02 and 06/07/02. Child treated with Rocephin IM x 2d. CBC showed increased WBC count, and increased granulocytes. Blood culture pending.
my arm was a little sore on monday, and the site of injection was red... Tuesday the red area had grown to about 3" in diameter.  Tuesday about 5 pm, I started having chills and felt like I was freezing, muscle aches, head aches, exhausted but was not able to sleep.  Wednesday, I feel like someone hit me with a baseball bat, and  the injection site is red and inflamed.
After I had my second vaccine of Moderna in February 2021 (and possibly it started after the first vaccine in January 2021, I was distracted and didn't pay attention to when it started), I began to experience a lot of pain in the bones in my hands. It seemed to take months to go away and eventually it did. After I had the third dose in August, 2021, the pain was back in my hands and lingered for about two and a half months. In October I went to the doctor and asked about the pain, Dr ordered an x-ray of the left hand (the right hand was painless by then and the left hand had been the more painful hand all along) and discovered osteoarthritis. This is the note Dr. wrote:    labs look good -inflammatory markers are wnl - her hand xray shows osteoarthritic changes in her wrist that I think are cause of her hand pain (dorsal pain) - so no signs of being r/t psoriatic arthritis that she has;  Within a few weeks of that visit, however, the pain in the left hand has subsided. I'm not sure if this is related to the Moderna vaccine or not. My mother had terrible arthritis so it seems to be in my genes.
The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter)  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  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 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.
Swollen in lips about 8 hours after vaccine; Numb in lips about 8 hours after vaccine; Tingly sensation in lips about 8 hours after vaccine; Menstrual bleeding even though period not due for 10 days; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Apr2021 at 13:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history had allergy to bee pollen. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 30Apr2021 at 21:45, the patient experienced swollen, numb, tingly sensation in lips about 8 hours after vaccine. She also had menstrual bleeding even though period was not due for 10 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen, numb, tingly sensation in lips about 8 hours after vaccine and menstrual bleeding even though period was not due for 10 days was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
May 18, 2006 called with a compliant states (10:00AM). Son's right arm, red, hot, swollen, no decrease ability to use arm, gave Tylenol/Motrin x 2.
Body felt like all my bones were broken when I woke up the next day I couldn't move I was in so much pain I could barely get out of bed for two weeks and the pain took 4 weeks to go away my mental health declined my meds didn't seem to be working I became very agitated for longer periods of time more manic than ever before as time went on I began to notice that now over a year later I have yet to be depressed once when before the booster shot I was depressed more than I was manic I would only have a manic episode maybe once every 6 months or so and it lasted only a day or two now it changes I'm never depressed but my manic episodes last anywhere from 3 days to the longest one lasting a week and a half and like right now I'm going on I guess you can call it a third manic cycle in a 3 week time span I finally come out of one just to go into another one a day or so later I'm starting to lose focus again I can't sleep the last time they happened like this I wasn't sleeping if I did it was only an hour or two and it lasted 3 months like this it's a total nightmare and instead of getting depressed it's like I'm a yoyo on a carnival ride doing jumping jacks that's how often my mood swings as and feelings and emotions change and there is nothing that can be done about it because it changes so often you can't learn anything from it to try and do anything about it and I think because of my mental health and lack of sleep it's caused short term memory loss issues I can't say it's for 100% sure the reason but idk what the cause is but it makes sense that it could be the booster shot completely changed my mental health and now I don't know how to deal with myself I can't function right I can't fix this I can't change this I'm am stuck and there's nothing that can help me so what am I suppose to do now
Vaccine was administered to patient on 01/22/2018. On 2/6/2018, patient called pharmacy to report that she has been experiencing pain in the left arm. Describes the pain as getting worse over the last week. Arm is not red, swollen, or warm to touch. In the first few days after vaccine, she said it felt like normal soreness from an IM injection but has since gotten worse. She has seen her MD for annual check up not related to vaccine and mentioned it to him. He did not seem concerned and said some patients experience soreness for a longer period of time. At this time, the patient is still experiencing soreness. I advised her to follow up with us or MD if this persists longer than a few more days.
This is a spontaneous report as received from a Registered Nurse. The nurse reported that unspecified patients were vaccinated on unspecified dates with improperly stored doses of PROQUAD lot number L9465057 expiration 17-MAY-2017; M-M-R II lot number L026551, expiration 16-JUL-2017 (MARRS# 1607USA0115876); and VARIVAX lot # L042267, expiration 27-OCT-2017 (MARRS# 1607USA004854). No adverse effect reported. No further information received. Lot number L9465057 is an invalid lot number for PROQUAD. This is one of several reports from the same reporter. Additional information has been requested.
10/01/2021: Warm red, swollen about 2-inches from injection site.Headache, body, joint and fever and flu-like symptoms. 10/4/2021: Sought care from ER and they gave treatment as for cellulitis. Antibiotics, cephalexin for course. Ongoing.
Fever 102 degrees last night. Coughing so hard her chest hurts, runny nose-hurts to take deep breathe. Had headache yesterday after vaccination. Wheezing 10-15 minutes after vaccination, used ALBUTEROL inhaler with relief shortly after, @ 1200 mother reported visit to MD who placed child on TAMIFLU - "Reaction due to previous start of virus not reaction to vaccine"
This spontaneous report was received from a pharmacist regarding a unspecified female patient of unknown age with none medical history or concurrent conditions. On 11-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX (0.65ml, intramuscularly; however, lot number and expiration date were not provided). There was none concomitant medications. On an unspecified date, reported as "a couple of days" after received ZOSTAVAX, the patient developed a fever and a swollen welt at the injection site which lasted for a couple of weeks (dates unspecified). The patient did not received treatment for the adverse events and did not seek medical attention. Laboratories tests were not performed. On an unspecified date, the patient's fever and the swollen welt resolved. At the time of reporting, causality between ZOSTAVAX and the adverse events were not provided. Additional information has been requested.
Redness is spreading and is even bigger than it was 2 weeks ago; Redness is spreading and is even bigger than it was 2 weeks ago; A spontaneous report (United States) was received from a consumer concerning a 76-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness was spreading and was even bigger than it was 2 weeks ago/ vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 18 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 016M20A) intramuscularly in right deltoid for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced redness was spreading and was even bigger than it was 2 weeks ago.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, redness was spreading and was even bigger than it was 2 weeks ago was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
injection site was red, inflamed and itchy. patient went to local clinic and was told to take zyrtec 10mg daily
Pain, swelling at injection site, redness, tender to touch, soreness with arm movement. RX-Observe, Ibuprophen, ice pack.
I woke up, four days after my vaccination, with a pain in the right side of my neck below my ear. I got up and looked and I had a red, round circle, 3 inches in diameter, with a dark purple dot in it. I called my doctor and he thought it might be an abscess. I went to my dentist and he took x-rays. He said that it was not from my teeth. He thought it may be a return of cancer so he called my PCP. I started an antibiotic. My dentist checked the temperature of the spot and it was a degree higher than my regular temperature. My PCP set up an MRI appointment for me and everything came back clear. I went to the emergency room and was told that I had a rash. I had blood work done at the ER and everything came back normal. I went to the ear doctor and he gave me the all clear. A couple of days after that, I started to feel better because of the antibiotics.
Brusing at injection site; Swelling at Injection Site; Joint pain; Shoulder Pain; This case was reported by a other health professional via call center representative and described the occurrence of injection site bruising in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX795AA, expiry date 31st August 2020) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Bexsero. On an unknown date, less than 2 months after receiving Bexsero, the patient experienced injection site bruising, injection site swelling, joint pain and shoulder pain. On an unknown date, the outcome of the injection site bruising, injection site swelling, joint pain and shoulder pain were unknown.   It was unknown if the reporter considered the injection site bruising, injection site swelling, joint pain and shoulder pain to be related to Bexsero.  Additional details were provided as follows: The patient experienced bruising at the injection site, swelling, joint and shoulder pain after dose 1 of Bexsero. The reporter did not consent to follow up. The reporter would not give any additional information about the patient.
Information has been received from a consumer concerning her daughter ("2 and a half year old at time of administration") who was vaccinated with a dose of ATTENUVAX. On an unspecified date, the patient developed "high temperatures and was pointing her neck". The consumer stated that they went to the hospital (name unspecified) at the time but she did not state that the patient was admitted to the hospital. The patient was recovered now. This is one of several reports received from the same source. Additional information has been requested.
Injection-site achiness and general body aches with each dose; Disorientation, hallucinations, phantom sensations, random body movements, somnambulance, narcolepsy, incoherence, and slurred speach started on 02/25/2021, building up from occassional to continuous with each vaccine dose; The later symptoms became so frequent and alarming that his oncologist ordered an MRI of his brain on 08/27/2021 (inconclusive) and stopped his chemo on 11/30/2021; on 12/09/2021, his symptoms were so bad I took him to the emergency room; after many tests he was diagnosed with idiopathic encephalopathy; while in the hospital he stopped eating altogether; on 12/30/2021 he passed away.
pt recv vax 2APR96 & 10MAY96 pt was dx w/AIDS;pt CD4 cell count was 9%;
Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a patient who was vaccinated with a first dose of Gardasil. Patient developed hives within 2-3 hours of receiving the injection. The patient's outcome was unknown. Additional information has been requested.