chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling terrible/feeling crappy/feeling tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling terrible/feeling crappy/feeling tired) and HEADACHE (headache) in an 84-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031279) for COVID-19 vaccination.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:afib on a "bunch of pills".  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine ( 1st dose: 24-Feb2021, lot number: 023M20A  2nd dose: 24-Mar-2021, lot number:048A21A  3rd dose: 01-Dec-2021, no lot number  4th dose: 02-Nov-2022, no lot number  5th dose: 10-Oct-2023 and lot number:3031279). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine. Concurrent medical conditions included AFib.    On 10-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 11-Oct-2023, the patient experienced FATIGUE (feeling terrible/feeling crappy/feeling tired) and HEADACHE (headache). At the time of the report, FATIGUE (feeling terrible/feeling crappy/feeling tired) and HEADACHE (headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient did not think that it was nothing serious but have feeling crappy.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745353 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745353:Wife case
Patient said he had reaction a day after receiving PPSV 23 and Flu shot. L arm swollen bright red down to elbow, very tired, can hardly drive back home after going to the gym. No breathing problem, no chest pain. He said he took ibuprofen which helps.
Moderna COVID?19 Vaccine EUA Patient's spine from  bra line and lower swollen. Pain present in vertebrae and disks. Sciatica like pain present in both legs due to compressed nerves. Patient has been unable to sit or stand comfortably since onset of symptoms and date of report (9 days). Pain persists at rest. Pain medication regimens to date have been unable to provide relief.  Patient is currently taking meloxicam 15mg 1x per day, Baclofen 10mg every 8 hrs, 1000mg acetaminophen every 6 hours and 5% lidocaine patch  12 hrs. Will begin physical theray.
9 days after the injection I noticed two red splotches at injection shot. It was very red and hot. This was not there before. I checked the injection site closely 48 hours after the injection was given. I am able to complete my duties at work at a slow pace.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 16-year-old patient who received Hepatitis A vaccine (batch number 3397T) for prophylaxis.   On 31-JAN-2023, the patient received Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-Apr-2023 The patient received unstable vaccines after a temperature excursion. The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Severe fatigue and generalized weakness.  Nausea and vomiting.  Fever 100.9 / chills  Headache  Backache   Injection site  soreness  Leg aches
swelling at the injection site, lasted for 1-2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site, lasted for 1-2 weeks) in a 20-year-old 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site, lasted for 1-2 weeks). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site, lasted for 1-2 weeks) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient had no concomitant medications.  No treatment medication was taken by the patient.   This case was linked to MOD-2021-219762 (Patient Link).
I waited onsite in my car for the recommended 10 minutes. Feeling fine, I drove away. I stopped at an Aldi about 7 minutes away to use the restroom and get a snack, as I had been at the fairgrounds for about an hour and had not had breakfast. While washing my hands, I noticed that my chest and neck were flushed red, much like when I drink certain alcoholic beverages. My left arm was also red up to my elbow. Feeling a little concerned, but still feeling generally okay, I bought a Snickers bar and a Coke, thinking it would perk me up. I checked out at 10:39AM, and got on the highway to head for home. I drank a bit of Coke, then took a bite of my candy bar. It felt a little weird when I swallowed, but went down okay. I took two more small bites, and each was more difficult to swallow than the last, with the third one not clearing the back of my throat without several sips of Coke to wash it down. I was starting to feel panicky, but figured response time would be relatively slow, as I was traveling in between jurisdictions. I remember my late  husband giving me Benadryl after I had a weird reaction to a flu vaccine in 2014, so I focused on getting to a store down the road where I could stop quickly for some. This took another 5 minutes from where I was. I bought a box of Benadryl Liqui Gels, and took one in the parking lot. I could still breathe, so I decided to drive home to my daughter, who was home alone. The Benadryl kicked in when I was almost home, so I did not call EMS.
Patient is immunocompromised and was supposed to be getting 0.5 ml of Moderna (lot# 012H21B) but instead she was given a booster of 0.25 ml  Pt also indicted that he had an allergic reaction to PEG, previous dose of COVID-19 vaccine, and that he was allergic to other vaccine and polysorbate.
Patient came to the pharmacy on 11/11/19 to report throbbing arm pain that started after the vaccine was administered on 10/16/19. She stated the pain in her left arm at the injection site began the day she received the vaccine, and has continued without relief. She stated she has tried taking over the counter acetaminophen but is still experiencing pain. I referred her to her primary care provider for follow up.
This initial spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. There were no concomitant medications, concurrent conditions or medical history reported. The reporter stated that since 06-MAY-2015, the patients were inadvertently vaccinated with unspecified number of doses of improperly stored GARDASIL injection (lot # K011562 with expiration date 08-APR-2017 and lot# K023432 with expiration date 18-JUN-2016; dose, strength and route were not provided). Product quality complaint (PQC) was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient describes as not "feeling good" day after injection. Developed nausea, vomiting & fever 101 & 102 on 11/21/2011. She called MD & MD said it was the "flu".
Dizziness intermittently starting approx 14 hours after injection. Off/on the rest of the day.
Received DTaP shot in left upper arm and 2 days later has severe allergic reaction with erythema induration and swelling. Started at injection site on deltoid and extends from acromion of shoulder to 13 cm distal and completely around upper left arm. Treated w/ Prednisolone 15mg/5ml.
Swelling at sight of injection, slight  nausea, shivering, slight headache, muscle soreness at sight of injection
body aches, taste of the medicine in my mouth, felt the shot move through my chest and tired from shot for over 5days
Her arm hurt till crying it was "Killing her"; 104°F fever; diarrhea; vomiting; pounding headache; could'nt sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm hurt till crying it was "Killing her"), PYREXIA (104°F fever), DIARRHOEA (diarrhea), VOMITING (vomiting) and HEADACHE (pounding headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (November).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt till crying it was "Killing her"), PYREXIA (104°F fever), DIARRHOEA (diarrhea), VOMITING (vomiting), HEADACHE (pounding headache) and INSOMNIA (could'nt sleep). At the time of the report, PAIN IN EXTREMITY (Her arm hurt till crying it was "Killing her") had not resolved and PYREXIA (104°F fever), DIARRHOEA (diarrhea), VOMITING (vomiting), HEADACHE (pounding headache) and INSOMNIA (could'nt sleep) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Treatment information not provided
Bloody nose started 2.5-3 hours after first dose, continued for two weeks, as well as, head aches and heart palpitations. Second dose continued nose bleeds, and ER visit for heart pain and heart palpitations
At injection site: swollen (an area approx. 5 inches by 3 inches), bumpy rash, and itching. Five days after initial reaction swelling is reduced but not gone, rash remains but no longer itchy.
Pt received 2nd dose of Covid-19 vaccine. Within 5 minutes she fainted but revived quickly. This happened a couple of times more. She was shaking for a short time. Whenever she comes through, she always say she is ok, to me and to her mom.  She says she maybe dehydrated and wanted to drink. I advised her not to take anything by mouth until she is stable. I started asking her mom if she is taking any medication for seizure and Mom says no. Pt  says she purposely shakes to wake up. Her shaking is not involuntary. No difficulty breathing. She was pale. A cold bottle of water was placed behind around her neck, head. I asked if she wanted to lie down on the floor and we will raise her leg from the floor, she says she'll do that if she feels worse. I told her to at least have her leg raised on one of our chairs which she did. Her mom and I observed her. Within 12 minutes, she got her color back. She says she's feeling better. When the 15minutes is up, we went to the BP monitor machine and Her BP is normal. 174/82mmhg. They said they'll wait a little longer, which I answered they are more than welcome to. Less than 5 minutes, they were gone.
This is a spontaneous report based on the information received by Pfizer from Merck (Service Request Number# 1-13928173306), by a contactable physician. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration at single dose on 27Mar2015. The patient medical history and concomitant medications were not reported. The patient received a cochlear implant on 07May2015 with outcome of unknown. No further information was provided.
This is a spontaneous report as received from a registered pharmacist refers to a 75 year old male patient who on 23-SEP-2010, was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot number 665512/0144Z, Exp. Date: 21-APR-2011). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 18-JAN-2012, the patient developed a case of shingles. No treatment information was reported. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for patient developed a case of shingles was unknown for ZOSTAVAX. Additional information has been requested.
Gave Pfizer dose in R arm and some of dose projectile out. Didn't seem like all of the dose but more than I would like. I have never seen that before. We draw up a 5/8th and 1 1/2 needle. This was one of the last vaccines of the day. I switched a 1 1/2 needle by drawing back replacing with a 1 inch needle and bringing back to the 0.3ml. It was not a vanish point. Patient educated and notified of VAERS report impending r/t unusual event. No health issue witness related to event.
seriously red around the injection site and down her arm; Joint Pain; Extreme fatigue; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (seriously red around the injection site and down her arm), ARTHRALGIA (Joint Pain), FATIGUE (Extreme fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (seriously red around the injection site and down her arm), ARTHRALGIA (Joint Pain), FATIGUE (Extreme fatigue), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, VACCINATION SITE ERYTHEMA (seriously red around the injection site and down her arm), ARTHRALGIA (Joint Pain), FATIGUE (Extreme fatigue), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Fever, fatigue, low grade fever, swollen lymph node in arm pit and neck. Heart SVT, rapid heart beat 48 hours later
Immediately after the 3rd vaccine full dose, I had soreness in the left arm and exhaustion. A week later, I regained some of my energy but started wheezing when I walked, and it didn't go away. I booked an evaluation with my new cardiologist, and I saw her on Nov. 1, 2021. She ran an EKG and diagnosed me with bigeminy and frequent irregular beats that I could feel. My blood pressure started to go up and under previous years I've been in good control. So, we had to add medications and increase others. And we did 2 Holter monitors 3 weeks apart to see if these medications were effective in controlling the irregular beat. I was feeling them, starting to wheeze more. My PCP put me on Symbicort inhalers which has fixed the wheezing and shortness of breath about 80%. The cardiologist 2 weeks ago started me on flecainide 50mg twice daily. We started this 2 weeks ago. It's controlling about 40-50% of the irregular beats and I'm supposed to call her today to report that and we may do another Holter monitor. We also increased my metoprolol from 12.5 to 75mg. we decreased amlodipine to 2.5mg once daily. I couldn't tolerate the 75mg of metoprolol so when she added the flecainide, we cut it down to 50mg of metoprolol in the evening. She also initiated a referral to an Electrophysiologist in Boston. I seem very sensitive to medications. My exercise level has improved, but only to 60% before the Moderna and having COVID. If I walk an hour, I have to sleep for 2 hours, so I'm not back, but it's better than it was. Going to ask the Electrophysiologist if I have to get the 4th booster. We are unsure if COVID has caused this or the Moderna. I think it's coincidental. Partially recovered.
On the 2/24 Tingleing in Left Fingers, hand and forearm. On 2/25 Tingling spread to my entire left side including my head & ear. continues to date.  Note my Vaccination was given in my left upper arm.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received the 2nd dose of SHINGRIX. On 22nd January 2019, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, injection site erythema, injection site swelling and sleepiness. On 24th January 2019, the outcome of the influenza-like symptoms, general body pain, injection site erythema, injection site swelling and sleepiness were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, injection site erythema, injection site swelling and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The next day after vaccination, when the patient woke up, she had flu like symptoms and felt achy all over. The patient was very sleepy and slept all day. The patient states that the injection site was red and swollen as well. After the call was concluded, the representative realized that they did not get injection site information. Attempt was made to reach out to patient to obtain this information. The patient did not consent to follow up.
swollen left eye. Started to hurt that night and woke up to a swollen left eyelid the next morning
Woke up at 2:36am, crying in physical pain with throbbing migraine and back pain down the spine [longissimus].  Fluctuated between cold finger tips to sweating.
Chills, muscle aches/myalgias, lethargy, severe arm pain. Recovered with bed rest overnight to no symptoms but minor arm pain in the morning.
Swollen, redness, and warmness around injection site initially. On second day: fever, swollen lymph node in axilla on same side as injection.
12 year old given vaccine for children under 59 months.  This patient does not have underlying medical issues which would warrant administering the vaccine.
Patient was under the age of 18 at tme of vaccination. No other adverse results were report by patient.
Information has been received from a physician concerning an 16 week old, female, with no pre-existing allergies, birth defects or medical conditions, who reportedly weighted 16 pounds (lbs) and 5 ounces (oz)and whose height was 25 and 3/4 inches (in) who in the "PM" on 15-AUG-2006 was vaccinated intramuscularly in the left thigh with a second dose of Hib conj vaccine (Lot #652867/0084F). On 15-AUG-2006, the patient developed seizure. On 16-AUG-2006, in the "PM" the patient developed seizure and urinary tract infection (UTI). Laboratory evaluation revealed aspartate aminotransferase 40, alanine aminotransferase 28, alkaline phosphatase 206, total bilirubin 0.1, ammonia 41, total protein 5.2, albumin 3.7, cerebral spinal fluid revealed: glucose 62, protein 22, 0 red blood cells, 0 white blood cells and urine culture revealed: E-coli >100,000. The patient had a renal ultrasound. Subsequently, on 17-AUG-2006, the patient recovered from seizure, and UTI. It was reported the patient had one sibling. Upon internal review, it was considered that seizure was an other important medical event.
Patient's arm at the site of injection started getting red, sore, swollen the evening of her injection. She describes having difficulties moving her arm due to swelling. She used ice packs and ibuprofen to help with pain/discomfort. As of Saturday morning (two days after injection), symptoms are improving but still present.
Pt developed likely autoimmune hepatitis about 2 months after her second shot.  She wanted this reported to the CDC in case it is a trend.
Varicella vaccine given left arm on 1/8/04. 1/19/04 mother noticed injection site swollen and red. Mother took client to doctor-doctor said "injection site infected."
Headache, Myalgia, NauseaVomiting, Sore throat,nasal congestion,fatigue,injection site pain and swelling, joint pain Narrative:
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 10-OCT-2017, the patient was vaccinated with 1 dose of expired PNEUMOVAX 23 (lot # M022086, expiration date: 10-SEP-2017, dose and route of administration were not provided). No adverse events were reported. No product quality complaint was reported.
SWELLING/TIGHTNESS ON LEFT SIDE OF FACE; ACHE; LEFT ARM PAIN; FEVER; This spontaneous report received from a parent concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to penicillin, alcohol user, and non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A,  expiry: 23-JUN-2021) dose was not reported, administered on 09-MAY-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAY-2021, the subject experienced swelling/tightness on left side of face. On 09-MAY-2021, the subject experienced ache. On 09-MAY-2021, the subject experienced left arm pain. On 09-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling/tightness on left side of face, left arm pain, ache, and fever. This report was non-serious.
Immediate face redness and swelling.  Later in evening no sleep and heart racing, next day no energy and body soreness.  Day 2 heart racing at night and no sleep.  Day 3 I was able to sleep through the night.
Cold, could not get warm on first night. I had four blankets, but teeth were chattering and muscles were aching and headaches. The following day, a rash on the left arm and right side of neck. Felt feverish off and on second day. Third day, felt better, but both rashes were bigger. I was taking ibuprofen on first second and third day. Taking benedryl on 2nd & 3rd day. The arm rash was blotchy, red, hard, and warm to the touch. It was very sore if you touched it. The neck rash is red, warm and blotchy, and occasionally itchy, but not painful.
I received Botox cosmetic 3 months ago. After 4 attempts every 3 weeks, the doctor said it wasn't working because of the Pfizer vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; botulinum toxin type a (BOTOX), since Oct2022 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INHIBITORY DRUG INTERACTION (non-serious), outcome "unknown", described as "I received Botox cosmetic 3 months ago. After 4 attempts every 3 weeks, the doctor said it wasn't working because of the Pfizer vaccines". The action taken for botulinum toxin type a was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.