chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearing sounds amplified; Sweating; Does not feel well; Trouble sleeping; tinnitus; migraine headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of TINNITUS (tinnitus) and MIGRAINE (migraine headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced TINNITUS (tinnitus) (seriousness criterion disability) and MIGRAINE (migraine headache) (seriousness criterion disability). On an unknown date, the patient experienced HYPERACUSIS (Hearing sounds amplified), HYPERHIDROSIS (Sweating), MALAISE (Does not feel well) and INSOMNIA (Trouble sleeping). The patient was treated with SUMATRIPTAN SUCCINATE (IMITREX DF) ongoing since an unknown date at a dose of 1 dosage form and METHYLPREDNISOLONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, TINNITUS (tinnitus), MIGRAINE (migraine headache), HYPERACUSIS (Hearing sounds amplified), HYPERHIDROSIS (Sweating), MALAISE (Does not feel well) and INSOMNIA (Trouble sleeping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Fibrin D dimer: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications taken by the patient were not provided. Action taken with mRNA in response to the event/s was not applicable  Very limited information regarding the events has been provided at this time.  Further information is not expected.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up information include:In general tab reporter details updated ln patient tab lab data includedIn product tab vaccine information updated and treatment information added.In event tab 2 events are added; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Burning Stomach-started about 50 hours following the administration of the vaccine. Not just below the breastbone, but my whole stomach felt like it was on fire. Treated with Pepsid and Tums, which did not help much. Lasted for a little over 48 hours.
Area of Induration approx 4 cm in diameter with redness of same diameter to one injection site of L LE one site of R Le. This was noticed by mother about 24 after vaccinations.
Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Client stated he received first dose of an MRNA vaccine from the department. Checked database and database for his record and there was no record of MRNA vaccine. Notified, Nurse Manager, of the client and current situation and she recommended Moderna as he claimed he could not remember if he had received Moderna or Pfizer. Administered Moderna Vaccine as a second dose for the client and patient had no reaction after 15 min of monitoring.
Case number PHEH2015US024720 is an initial spontaneous report received from a nurse on 24 Nov 2015. This report refers to a 3 year old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1517001) intramuscularly on 23 Nov 2015. No adverse events were reported following this maladministration (drug administered to patient of inappropriate age).
Body aches; Slight fever/fever of 100 degrees Farenheight; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Body aches), PYREXIA (Slight fever/fever of 100 degrees Farenheight) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced MYALGIA (Body aches), PYREXIA (Slight fever/fever of 100 degrees Farenheight) and HEADACHE (Headache). On 04-Feb-2021, MYALGIA (Body aches), PYREXIA (Slight fever/fever of 100 degrees Farenheight) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 100 (High) Fever reached 100 degrees Fahrenheit.     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.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-390831 (Patient Link).
Patient called about her flu shot that she had received 9/25 in her left arm. She has had shoulder pain and limited mobility since the vaccine. She states that the vaccine was given very high on her arm above her deltoid  about 1cm down from her shoulder. The vaccine itself was very painful also. She has been to the doctor who confirmed that he feels it was related to the vaccine because only 1 tendon is affected instead of the entire rotator cuff which would be more typical of an injury unrelated to a vaccine. Patient is now having physical therapy for 6-8 weeks.
After the vaccine in July 2021 pt. has had a daily migraine/headache every day and has developed Inappropriate Sinus Tachycardia and POTS. She has been seeing multiple specialists, Neurologist, Cardiologist, ENT, Allergist/Immunologist, GI, Psychology, Psychiatry and there is still no resolution to her problems. She has had to leave school and was in a Mental Health Partial Hospitalization Program and Intensive Outpatient program for 6 months. She now homeschools and in addition to traditional medicine we have tried chiropractor, acupuncture, nutritional supplements, individual therapy, group therapy, physical therapy looking for a solution to these medical problems. She has been on lots and lots of medications but none will stop the daily migraine. Symptoms have gone on for 19 months. They include: daily migraine, fatigue, brain fog, memory problems, dizziness, lightheadedness, racing heart, excessive sweating, anxiety, nausea, vision problems, excessive urination
Pt reports arm swelling. Advised to take antihistimine. Pt took Benadryl. Pt reported later having chills and a mild fever.
I just been having lingering chest cold and mucus since the vaccine. The mucus is white. Went to a lung specialist.
Woke up with chills.  Lasted about 3 hours.  Took 1-Naaproxen Sodium pill
Patient experienced a feeling of 'shortness of breath' and mild chest tightness approximately 30 minutes after receiving vaccination. He went to work for the remainder of the day.  The following day symptoms continued at work and he went to local emergency room, where EKG, CXR, and labs were performed.  EKG showed NSR.  CBC, d-dimer, troponin, and BMP were WNL. CXR read as normal.  No meds prescribed and he was discharged home. On follow up one day later, he felt a little better but still slightly short of breath and has pain in chest with deep breathing, and felt better laying prone or standing up.  Worse when sitting. He was prescribed motrin 800mg to be taken 3 times daily, and was placed on light duty.
Participant had trouble breathing after being vaccinated. Participant says she has asthma and COPD. Participant was fine after taking inhaler and resting.
patient received Menactra 0.4 mL (instead of 0.5 mL) with no reported adverse event; when patient retracted the syringe 0.1mL came back into the syringe with no reported adverse event; Initial information was received on 29-Jul-2021 regarding an unsolicited valid non-serious case received from a physician via Agency under reference number-0702910). This case involves a 11 year-old male patient who was vaccinated with 0.4 mL dose (instead of 0.5 mL) of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] due to while retracting the syringe 0.1 mL came back into the syringe (underdose) (Device deployment issue).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 29-Jul-2021, the patient received 0.4 mL first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6952AB  and expiry date 06-Sep-2022) via  an intramuscular route at the left deltoid for prophylactic vaccination.  It was reported that "The caller would like to know if the injection was valid. Caller asking if the MENACTRA dose would need to be re-administered since the patient will be receiving a booster as well. Caller states that the provider thinks that the patient will be fine since it was such a small volume that the patient did not receive".  It was a case of an actual medication error due to  vaccine underdose (latency was on same day).   It was also a case of device retraction issue.  At the time of report, no adverse event reported.   Outcome of event was unknown.   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.
This spontaneous report as received from a medical assistant, referring to a patient of unknown gender and age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 11-MAY-2017, the patient was inadvertently vaccinated with one expired dose of GARDASIL 9 lot # L004014 with expiration date on 04-MAR-2017 (strength, anatomical location and administration route were not reported) for prophylaxis, however no adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1706USA010260.
Thigh swollen, red, pussy, tender to touch, low grade fever. Told to seek medical treatment at emergency room or urgent care
Two days after receiving injection in left arm the injection site became red and hot to touch. Within three days it was severely red, hot to the touch, and continues to be.  I also have raised spot with sore arm and itching around red spot.
Information has been received via internet concerning a 16 year old female who on unspecified dates was vaccinated with the first two doses of GARDASIL.  Subsequently the patient experienced fainting, stroke, memory loss which was devastating. The patient stated that she could barely walk, she was so dizzy that she would have to just sit down. The patient's mother stated that physician diagnosed her daughter with nerve damage caused by GARDASIL. Upon internal review, stroke was considered an other important medical event. Additional information has been requested.
couple of hours after receiving the injection, I had a large hive on my mid chest area. Later I had one on my hip. I was not concerned as I have them on occasion. I felt fine. Went to bed that evening and woke up with extreme burning and itching in my index finger and thumb of my right hand. Also a very large hive on the inside of my arm about 2 1/2 inches from my wrist bend. Intense itching.  I took a Benadryl tablet and felt better almost immediately. Later in the day about 6 1/2 hours later, I had more itching on my hip where the high was located. I took another Benadryl. I am fine. I also call my doctor and reported it.
decreased range of motion in vaccinated arm: unable to raise left arm above shoulder x 72 hours now due to pain. no associated numbness or swelling.  I am a surgeon and this impacts my work  and driving. I would not have been able to operate during these last 3 days and while the pain is better 72hrs later, my arm is still out of commission.  I think we need to inform healthcare providers who perform procedures that they may want to schedule the vaccine when no planned procedures for at least 72 hrs.  Due to this issue I will be unable to proceed with the second dose, unless I can take it a week later than the scheduled January 24, 2021.  It is taking too long to regain full function of the arm but i expect it will be back to normal as it is better today 72 hrs later.
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 4/14/2023 NONALCOHOLIC FATTY LIVER G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 4/14/2023 ADHD, PREDOMINANTLY INATTENTIVE PRESENTATION
I experienced fever for three days and pain all over, sore throat, nausea, and vomiting. I went to see my PCP who told me to stay away from my granddaughter for a week and provided me with an excuse for work. My throat is still sore along with the fatigue; however, I am getting better.
Information has been received from a nurse concerning a patient (age and gender not specified). On 08DEC2014 the patient was vaccinated with M-M-R II, .5 ml, subcutaneous. The expiration date of the vaccine was 27JUL2014 (Reported Lot number J008882). The outcome of expired vaccine administered was unknown. Additional information has been requested.
1 WEEK AFTER VACCINE NOTED SWELLING AND REDNESS IN ARM AT INJECTION SITE.  1 WEEK LATER SWELLING REDUCED
Mild headache, chills and temperature of 100.3F. Resolved with tylenol 500mg PO one dose.
burning during injection; This case was reported by a consumer via other manufacturer and described the occurrence of injection site burning in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) (batch number UNK, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, immediately after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site burning. On an unknown date, the outcome of the injection site burning was unknown.   It was unknown if the reporter considered the injection site burning to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported to had burning during injection of flu shot.; Sender's Comments:  US-MYLAN-AE-2021-7214:ID
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN CHRONIC HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 1/22/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I had quite an adverse reaction to the second MODERNA vaccine.  That afternoon and evening I developed symptoms.  I was experiencing chills, fever, body aches, headache, sore throat, shaking and nausea.   As the week went on, my reaction became worse. I was sweating profusely and had shortness of breath accompanied with burning pain on the top of my hands and feet and a rash.  On Friday morning, 5 days after the vaccine, I collapsed and had a stroke.  I was rushed to hospital and was admitted.  It was confirmed that I had a stroke. through a Cat Scan and MRI.  On Saturday, I had another stroke.  This time I was transferred  to hospital.  I had a huge blood clot on the left side of my brain which has effected my speech and walking.   My entire life has been effected and changed.  I had  a plethora of tests done, MRI, CAT SCAN,  EKG, BLOOD WORK etc.  I also have to have speech therapy, physical therapy and occupation therapy.    I spent about  weeks in the hospital.  The doctors think it is a possibility that the 2 Moderna vaccine caused my two strokes.  What can be done about this?  I will  have problems for the rest of my life.
Patient was admitted as Observation on this day (10/7/2021) for STEMI (ST elevation myocardial infarction) (*) involving pRCA and mLAD. Patient was transfer to hospital from outside ER and was taken to the cath lab as priority 1. Now S/P DES to pRCA and mLAD.    Patient was tested for COVID-19 and was positive on 10/7/2021.
This is a spontaneous report from a contactable consumer reporting on behalf of his mother. A 87-year-old female patient received first dose of PREVNAR 13 at single dose on an unknown date for immunization. Medical history included osteoporosis, atrial fibrillation (about 4 years before this report), pacemaker (about 4 or 5 years before this report, an ablation was done) and ongoing spastic colon (she had all of her life). Concomitant medications included influenza vaccine for immunization within a month. In Oct2016 the patient experienced diarrhea. As treatment the patient received Colestipol and Imodium. She had gotten better from diarrhea, then was diagnosed with walking pneumonia in Nov2016. The patient was prescribed two antibiotics: azithromycin (ZITHROMAX PACK) once a day and a cephalosporin type antibiotic, then she had diarrhea again. The reporter thought that antibiotics were the cause for diarrhea. She was taken off the antibiotics. An X-ray was done on an unspecified date in 2016 that showed that her chest has cleared up.
I started vomiting at 2 AM and continued until hospitalization at around 9 AM. I also had severe chills and a body temperature around 94 degrees when I am usually around 97. I was throwing up every 15-20 min.  Was treated with plenty of fluids, plus magnesium, NS bolus, Pepcid, potassium chloride, Toradol, and Zofran.
swollen tender lymph nodes requiring CT chest with contrast and then Ultrasound and 2 different antibiotics
No additional AE reported; Caller is a vaccine coordinator calling to report a temperautre excursion for VARIVAX. Caller reports that the VARIVAX was stored in the refrigerator since 15NOV2021. Caller reports that the refrigerator had an excursion with maximum temperautre of 5; This spontaneous report has been received from a vaccine coordinator, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 21-APR-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX 9) subcutaneous injection, 0,5 milliliters (ml) as prophylaxis (lot number: U015678, which was determined to be valid, with an expiration date on 18-MAY-2023) (scheme, route and anatomical location of administration were not reported) (product storage error). The administered dose was placed on a refrigerator since 15-NOV-2021, where it underwent a temperature excursion with a maximum temperature of 51 degrees Fahrenheit (F) for an unspecified amount of time. It was unknown if any previous temperature excursion took place. No additional adverse event was reported.   This is one of four cases from the same reporter.; Sender's Comments:  US-009507513-2209USA006073:
woke up with shooting pains in legs, sick to my stomach, severe stomach pain, woke up on kitchen floor, couldnt walk so i crawled to bed, wokeup fine
Pt received vax in 1997. On 9/2/99, the pt broke out in chickenpox with marks on her torso and many on her legs. She was seen by the school nurse.
Within 15-minutes of vaccination, the patient had a near-syncopal episode and became diaphoretic and dizzy. EMS evaluated the patient on-site. Initially, the patient was hypotensive (66/42), but was administered 600mL normal saline and BP improved (127/96). EMS transported the patient to Hospital Emergency Department. In the ED, the patient stated they experienced feeling lightheaded after vaccination. The patient was hypotensive (96/57) on arrival. Patient noted they had been working at a golf club in the sun the last few days and may be dehydrated. The physician administered 324mg PO Aspirin. Given the patient's concerns and labs/test results, the patient was discharged with vasovagal near-syncope and hypokalemia.
This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II nd ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. Rotavirus vaccine Date given 11/02/2012. Lot # 0210AE. Additional information has been requested.
I have to confirm the dates with her Nursing school, but approximately two weeks after receiving the shot my sister experienced stroke like symptoms, she went to the doctors and had to take off from school.  Her heart was not checked, but had never been diagnosed with heart problems about a year later she died in her sleep from a heart problem that was misdiagnosed.
Breakthrough case admission after 4 vaccines Moderna 3/2/2 Lot# 002A21A;  Moderna 3/30/21 Lot# 0047A21A;  Moderna 12/23/21 Lot# 041J21A;  Pfizer 9/22/22 Lot# GH9703
onset of vomiting 2AM 7MAR96,rhinitis,fever 102 axillary;very lethargic-AM;seen by MD PM exam neg x/for URI;nl behavior by 8MAR96;MD states pt may have DTP age 5yrs
3MAR92 fever 103 (in the evening), stared into space, joints became stiff, wouldn't sit lasted less than 1 min; 4MAR92 fever 105; mom took pt to MD both days;
2 hours, post vax, pt complained of sore throat. 4 hours, post vax, pt had hives on left side including back, arm and leg. She was given Benadryl by mom after consulting with MD.
Blood pressure spike, nose bled, before and after malaise, strong hunger, tingling and coldness in arms and legs (last part occurred two days in a row).
This spontaneous report has been received from a nurse concerning an unspecified number of patients of unknown age and gender. Medical history and current condition of the patients were not reported. On an unknown date the patients were vaccinated with a dose of improperly stored VAQTA (lot#, expiry date, dose unspecified). Concomitant therapy was not reported. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports received from same source. Additional information has been requested.
From 6/20/01 to 6/23/01 pt had a low grade fever. On 6/23/01 he had redness and a knot on right medial thigh area. On 6/25/01 he began to have a rash to face, trunk, arms and legs,and mother took pt to MD. On 6/26/01 mother called health dept to report that the knot looked better but that the pt continued to have rash to entire body.
rash on both distal forearms rt elbow & upper abdo; raised red cluster of macules approx dime sized; severe itching;
Fatigue started evening of 1/7/21, I awoke about 1:30am 1/8/21,with headache, body aches, chills and nausea.  Took advice at approximately 7am, then able to fall asleep. Woke at 11am, felt better, very tired for the remainder of the day. 1/9/21, symptoms gone upon rising in the morning.
Client's mother reports child has a fever, headache, muscle aches, and generalized non-raised, red, itchy rash over arms and trunk.