chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; Arm is sore; Some days better than others as far as how she feels; Hypotension; Fatigue; occasionally feels exhausted; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore), FEELING ABNORMAL (Some days better than others as far as how she feels), HYPOTENSION (Hypotension) and FATIGUE (Fatigue; occasionally feels exhausted) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 15-Apr-2021, the patient started TREPROSTINIL SODIUM (TYVASO) (Other) 0.6 milligram per millilitre, 18-54 µg (3-9 breaths) four times a day (QID) via inhalation (IH) route.. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore), FEELING ABNORMAL (Some days better than others as far as how she feels), HYPOTENSION (Hypotension) and FATIGUE (Fatigue; occasionally feels exhausted). At the time of the report, DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore), FEELING ABNORMAL (Some days better than others as far as how she feels), HYPOTENSION (Hypotension) and FATIGUE (Fatigue; occasionally feels exhausted) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.   The patient reported that she just had COVID booster and arm was sore, some days have been better than others as far as how she felt, blood pressure was low at times with some dizziness, and also occasionally felt exhausted. Action taken with Tyvaso was not reported for the events of pain in extremity, feeling abnormal, hypotension, dizziness, and fatigue.
He had chest pains and could not breath after 48 hours, rushed to the ER.  Stayed in the hospital for 4 days.  He had a heart attack and was diagnosed with acute idiopathic myocarditis.
Bell's Palsy; dizziness; This is a spontaneous report from a contactable consumer (patient). A 38-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN5318), intramuscularly administered in left arm on 24Jan2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunization at workplace clinic. Medical history and concomitant medications were none. Prior Vaccinations (within 4 weeks) were none. The patient experienced bell's palsy and dizziness on 09Feb2021. Bell's palsy occurred after receiving 1st COVID vaccine and the patient did not guesting it because there was family of bell's palsy. No treatment was received as a result of the events. The outcome of the events was recovered in 2021.
stomach was a little upset; chills; fever yesterday was 100.8; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach was a little upset), PYREXIA (fever yesterday was 100.8) and CHILLS (chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (fever yesterday was 100.8). On 11-Mar-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach was a little upset). On 13-Feb-2021, PYREXIA (fever yesterday was 100.8) outcome was unknown. At the time of the report, ABDOMINAL DISCOMFORT (stomach was a little upset) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 100.8 (High) 100.8.         No concomitant medications and treatment medications was provided.   This case was linked to MOD-2021-042700 (Patient Link).
diarrhea; lethargy; headache; muscle ache; patient lost 13 pounds; This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced diarrhea, lethargy, headache, muscle pain and weight loss. On an unknown date, the outcome of the diarrhea, lethargy, headache, muscle pain and weight loss were unknown.   The reporter considered the diarrhea, lethargy, headache, muscle pain and weight loss to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and reported some unrelated side effects including diarrhea, lethargy, headache, muscle aches and the patient lost 9 pounds. The patient felt like a normal human being. The reporter consented to follow up and could follow up directly with the pharmacist. This case linked with US2020156554, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020156554:same reporter
Information has been received from a medical assistant concerning a 15 year old female with no known drug reactions or allergies who was vaccinated with a dose of GARDASIL vaccine (yeast) and now has tested positive for high risk HPV DNA and has an abnormal Pap test. The patient received at least one and possibly two vaccinations with GARDASIL vaccine (yeast) prior to the abnormal Pap and HPV DNA test on 27-MAY-2008. The vaccination with GARDASIL vaccine (yeast) were not administered at the office in the case. The patient had never had an abnormal Pap or positive HPV DNA test in the past. It was unknown whether the patient sought medical attention. Patient outcome was not reported. Additional information has been requested.
Myalgia, Fever, MYALGIAS Narrative:  stated Took otc tylenol with improvement  for fever ,chills, myalgias
Patient reports 2 inch x 2 inch red area at injection site 24 hours after vaccination. 48 hours after vaccination red area was 5 inches long x 2 inches wide, tender and hot to touch.  Patient reports vaccinated arm hurt to move and there was some spotting on the back side of the arm. Patient went to PCP for treatment. Red area was marked by PCP and patient told to monitor for 24 hours. Patient instructed to start Cephalexin if redness moved beyond marked area in another 24 hours. Patient reports redness did move beyond marked area and she did start Cephalexin as instructed. Patient reports redness is now almost gone and arm is no longer sore.
8/4/23-Pts mom and dad called reporting that they are out of state at this time but that pt was given a Tdap and meningococcal vaccine at our facility 8/2 in which they have noticed pt having a localized reaction to pt R arm, they described it as raised, warm to touch, red. Parents reporting that pt doesn't have hives, changes to breathing, swelling to I had parents send a picture of area, viewed with provider and recommendation was made to try cold compresses, give pt a childs benadryl/zyrtec and if they have any questions on dosing of this ask pharmacist that they pick med up from. Educated parents to outline red area with sharpie to ensure that it isn't growing with use of antihistamine. Educated parents to take pt starlight to ER if pt develops any changes to breathing, swelling to eyes, throat, trouble swallowing, rash increases and doesn't improve with medication. Parent verbalized understanding.   8/7/23 Called to f/u with pt mom in regards to pt vaccine reaction to R shoulder. Mom reports that they ended up taking pt to ER as pt reaction didn't improve with Benadryl given and that they were told in ER that there isn't much they could do for pt other than let it take its course. Mom reports pt is doing much better this morning and that redness has significantly gone down. Mom reports in the future they will give 1 vaccine at a time. Communicated to contact clinic if we can done anything for them, mom verbalized understanding.
fever began 17JUN98 p/vax;earlier in day family didn't have thermometer;taken to ER had fever & vomiting;
patient describes painful burning sensation and trouble getting out of bed in the morning.  Patient was told by physician it was their kidneys, but no lab tests were collected.
Left arm, red, raised welt, size of a grapefruit. Headache, Body aches, Chills, Fever, Extreme fatigue.
After receiving DTaP, IPV and HAV, developed a cough, wheezing and facial rash. Responded to epinephrine albuterol aerosol, Zyrtec, Singulair and Prednisone without sequelae has transported to ER (after treatment in office) for reevaluation.  06/14/2007 MR received for ERvisit for c/o coughing and wheezing after immunizations in ped office.  AS they were leaving ped office child began a very hard coughing spell and then began wheezing.  RTO and was given Epi, Zyrtec, Singulair and nebs.  Transported via EMTs to ER. No sx noted by the time they reacher ER. D/C DX:  Reactive Airway Disease/Wheezing.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rash at site of injection site which spread down the arm and to the other arm and legs.  Large lump on right side of upper back.  Symptoms have persisted.  Rash is consistent with a contact dermatitis type of rash.
Tiredness; Vaccination site pain/Sore arm from covid booster vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain/Sore arm from covid booster vaccination) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. On an unknown date, the patient experienced FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain/Sore arm from covid booster vaccination). At the time of the report, FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain/Sore arm from covid booster vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin D: low (Low) Low.         Concomitant medications were not reported. Reporter causality for HUMIRA(ADALIMUMAB) for the events Vitamin D low, Tiredness and Vaccination site pain was not reported. Dose 2 information was not reported. Treatment medications were not reported.
approximately 5-6 minutes after receiving her first Moderna covid19 dose, this patient began to feel weak, dizzy and felt tingling in leg. Questioning about symptoms revealed she had no other symptoms at first.  A blood pressure check revealed blood pressure was 186/100. She was feeling anxious and said her heart was racing.  I asked patient what her blood pressure usually runs to which she responded she did not know.  I asked her is she was feeling fine and she said she felt like she was having trouble swallowing. With her consent I gave her a glass of water and 5ml of diphenhydramine 12.5mg/5ml. Checked blood pressure again and it was 200/118. Throughout the process I asked patient about cutaneous, respiratory, gastrointestinal symptoms.  She reported no itching; her face showed no swelling or pallor--I had asked her to pull her mask down three times to check for redness, swelling.  There was none.  Some minutes into the episode she reported that she felt much better. I asked her to stay seated for 10-15 minutes to make sure she was feeling fine. After 15 minutes she told me she felt fine and was ready to leave
8 days after injection, developed severe pain in right shoulder both at rest and with movement. Severe reduction in range of motion. Unable to sleep at night. No relief from acetaminophen 500mg and 200mg ibuprofen every 6 hours. Unable to perform daily household work due to pain.
Patient with 3-7 days of weakness. Hospitalized 2/16-2/20 for fever weakness and SOB. Diagnosed with COVID-19 and UTI. Did require O2 per NC briefly. Was treated with IV/PO dexamethasone and IV/PO Cipro Discharged to home
devel tender, itchy indurated area 4cm x 8cm @ site of vax;arm felt weak given ibuprofen & cold pack on arm;arm better 14MAY96;devel episode of epiglottis 13MAY95 tx keflex & decadron
kinrix was given , pt is only 4 months old Family was notified, baby is doing ok
Client took 1st dose of oral typhoid at 9:30am on 11/24/02-experienced nausea, dizziness, some diarrhea c/o feeling "drugged" passed out at 6:30pm-was seen in the ER. They sent her back to health dept for follow up R/T immunizations.
She had vaccine at 11 am.  States felt fine until that evening around 8 pm.  Complaint of fever, chills, and could not get a good breath in.  She then had diarrhea and vomiting.  After vomiting she did feel better.  She feels some better this am.
Narrative: COVID infection following COVID vaccine series 02/18, Pfizer, dose #1 03/11 Pfizer, dose #2 12/23 COVID swab, result: detected 12/23 pt cc: cough, chills, fatigue, fever, headache, myalgias, nausea exposure: unknown 12/23 SARS-COV-2 Variant Sequencing: pending 12/29 clinically resolved
Lightheadedness; Ringing in ears; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), TINNITUS (Ringing in ears) and VACCINATION SITE PAIN (Arm was sore) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003b21a and 001c21a) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (Lightheadedness), TINNITUS (Ringing in ears) and VACCINATION SITE PAIN (Arm was sore). On 24-Mar-2021, DIZZINESS (Lightheadedness) and TINNITUS (Ringing in ears) had resolved. On 26-Mar-2021, VACCINATION SITE PAIN (Arm was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-186612 (Patient Link).; 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.
pt recvd 2nd dose of vax JUN & devel a burning sensation w/inject w/soreness & or aching sensation in the arm; This sensation persisted assoc w/feeling of heaviness in the arm; pt denies fever, local swelling or erythemia
That same night at 7 pm I started feeling severe pain in my back where I have L-4,L-5, S-1 lumber issues and also started having neck and shoulder pain C-4, C-5. I had fever, chills, severe body ache, muscle pain, heart palpation, and shorten of breath as well. I took Tylenol and two Tylenol flu to help with the symptoms. The body ache went on for 3 days so I kept taking Tylenol flu for day and night time. After 3 days everything got better except neck should pain and back pain. The shoulder pain stayed for over 3 months and I had to take pain killers and had to go for massages and use different electrical devises to reduce the pain and also stimulation.
Patient reports she returned home after receiving the vaccine and took a nap. When she awoke from her nap her left leg was numb. She states that sensation is unusual, and it continued through until she reported it to the pharmacy on 11/24/17. She has  not been able to reach her primary care provider.
vomitting, diarrhea, hypotension, bradycardia 2 hours after the vaccine was given treatment: placing the patient in trendelenburg position until BP improved after 1 hr
Patient received extra dose of immunization, only 2 dose series, patient received 3 doses without any symptoms.
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 61 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, 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 holders 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.
paramedic called for a 47 female here for first covid vaccination. no prior h/o reaction to other vaccines . pt followed by cardiology for unknown congential heart condition c/b episodes of tachycardia s/p "stress test " a few weeks but unable to complete the stress test. pt pt denies meds for her cardiac condition . approx 9 min after covid vaccine pt c/o substernal "indigestion type" chest tightness a/w sweating and globus sensation of the throat. pt did not have rash or hives or flushing or angioedema or shortness of  breath or wheezing or dysphonia or stidor. exam pulse 84 bp  177/112 r 18 afeb  pt did not appear in distress heent no angioedema cor rrr without murmur or gallop chest clr p&a. pt refused epinephrine but accepted oxygen. clinic did not have an ekg to assess cardiac status. but emt rhythm strip showed sinus tachycardia. pt transported ED without any medication intervention by emt
EXTREME SWELLING AND REDNESS COVERING ENTIRE BICEP AND DELTOID. HARD TO THE TOUCH, FEVER IN ENTIRE UPPER EXTREMEITY. 30MM FLUID FILLED BLISTER RASH AT INJECTION SITE.
Moderna on 1/22 and 2/18. Positive on 8/5 admitted 8/4-8/10
Information has been received from a physician concerning a female pt who in Feb 00 was vaccinated with varicella virus vaccine live.  On 03/04/04 the pt was seen in the MD's office with three chickenpox. The pt sought unspecified medical attention. There was no product quality complaint involved.  It was also reported that four other pt's developed chickenpox after being vaccinated with varicella virus vaccine live (WAES # 0403USA01611, 0403USA01644, 0403USA01645, 0403USA01646).  Additional information has been requested.
Information has been received from a case in litigation concerning a male child who 17-SEP-1996 and 15-OCT-1996 was vaccinated with first and second doses of RECOMBIVAX HB (manufacturer unknown). It was reported that the patient exhibited the first symptoms of Juvenile rheumatoid arthritis 11 days after the second vaccination, including muscle ache, rash, fatigue, joint pain, swelling and stiffness. Additional information is not expected.
Patient inconsolable for 30 minutes. RN at bedside to assess prior to DC and pt presented with round-taunt abdomen. Bowel sounds hypoactive. Stooling x4 watery yellow/brown stools. Temp 97.5F.  X-ray with pneumatosis, no free air on decub. Has been having watery stools. Emesis 10 ml. OG placed with aspiration of 30 ml feculent fluid. Bloody stool in diaper.  Later decubitus film confirms small amount of free air. Will proceed with ex lap.  Patient returned from OR.   Surgical team noted that they did not find any perforation or ischemic bowel.  No resection was performed and the abdomen was closed.   Plan to extubate in AM, continue NPO, begin zosyn x 7 days and gentamicin x 2 days (if cultures remain negative).
After 6 hours of receiving vaccine, patient experienced wheezing,chills,malaise,tiredness and fever equal or more than 101