chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complained of high fever, shivering and muscle pains a day after taking the shot. Patient was advised by the pharmacist to take motrin and call her physician.
10/9/19 received steroid injection Rt shoulder for arthritic pain; followed by flu vaccine in Lt arm; followed by pneumovax 23 vaccine in Rt arm. Within 24 hours developed pain, muscle spasms, and immobility of Rt shoulder (adhesive encapsulitis). I went to chiropractor for 1 month w/o improvement; followed by 3 months physical tx; cold laser tx; H2O exercises; and daily swimming. On 11/29/19 Actemra was added and on 12/5/19 2 mg Prednisone was added to current MTX tx for RA. On 1/7/20 started an 8-day steroid pack for tx adhesive encapsulitis. 1 year post vaccine I still have crunching noises and pain upon movement, along with a reduction in the range of motion of the arm.
Patient reported that the day of her vaccine, she experienced a sore arm and shoulder. The next day when she awoke her neck was also sore. She feels that the pain is getting slightly worse and spreading to the back of her shoulder. Is somewhat limiting the use of her arm. Tried taking a muscle relaxer 10/29 PM to help with sleep and isn't sure if it helped her shoulder, but she felt slightly better when waking up, but is still having pain.
Pt fell down stairs cut forehead. Was administered Hyper-tet as well as Tetanus & Diphtheria Toxoids Adsorbed and developed increasing paresthesia progressing  from feet to waist w/development of neurogenic bladder and weakness in the legs.
pain in left arm; tenderness in left arm; both breasts were tender; discomfort and it felt like needles in her breasts; rush of more blood flow under the skin; horrible feeling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm), TENDERNESS (tenderness in left arm), BREAST TENDERNESS (both breasts were tender), BREAST DISCOMFORT (discomfort and it felt like needles in her breasts) and SENSATION OF BLOOD FLOW (rush of more blood flow under the skin) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTI VITAMINS & MINERALS and CALCIUM for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in left arm), TENDERNESS (tenderness in left arm), BREAST TENDERNESS (both breasts were tender), BREAST DISCOMFORT (discomfort and it felt like needles in her breasts), SENSATION OF BLOOD FLOW (rush of more blood flow under the skin) and FEELING ABNORMAL (horrible feeling). On 25-Apr-2021, PAIN IN EXTREMITY (pain in left arm) and TENDERNESS (tenderness in left arm) had resolved. At the time of the report, BREAST TENDERNESS (both breasts were tender), BREAST DISCOMFORT (discomfort and it felt like needles in her breasts), SENSATION OF BLOOD FLOW (rush of more blood flow under the skin) and FEELING ABNORMAL (horrible feeling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-219650 (Patient Link).
Pt. took 4 vaccines at once total (3 intramuscular and one oral) at the age of 8 week on May 03rd 2022. By the end of the same month, we started noticing a weird jerking movement (Moro reflex alike) that happens in clusters. This movement was subtle first and became more obvious and dominant. In June, she was diagnosed with infantile spasms. Before the vaccine, she was a healthy baby, hitting her developmental milestones like any normal child. We have done multiple tests to rule out genetic reasons, metabolism, pregnancy issues, delivery issues; all were clear. Looking back, we believe vaccines taken on May 03rd 2022 were the main culprit to her diagnoses; Taking all 4 vaccines at once and, specifically, taking the (DTaP-HBV-POL) which is on the contraindications list for infantile spasm and uncontrolled seizures.  Pt. has relapsed twice. she was treated with Prednisolone (Once for a month in June 2022), ACTH (Twice in August 2022 and December 2022) and currently on Vigabatrin (Starting in July 2022). She is currently in the process to being surgically evaluated.
TERRIBLE REACTION TO THE FOURTH DOSE; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (TERRIBLE REACTION TO THE FOURTH DOSE) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphoid leukemia.    No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient experienced IMMUNISATION REACTION (TERRIBLE REACTION TO THE FOURTH DOSE). At the time of the report, IMMUNISATION REACTION (TERRIBLE REACTION TO THE FOURTH DOSE) had resolved.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sudden onset of severe total body muscle aches with abdominal pain; no rash or fever; no treatment; followed abnormal CK and bilirubin; US of belly; EBV and CMV titers (nl); self improved over 10 days.
Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional (medical assistant) and additional information was received on 23-Jul-2018. This case involves a two-months old male patient who was vaccinated with an 0.5 ml first expired dose of PENTACEL (batch number: C5390AA, expiration date: 17-Jul-2018, route and site of administration were not reported) on 20-Jul-2018. The patient's medical history and previous medications were not reported. The patient's concomitant medications included PREVENAR 13; HEPATITIS B VACCINE and ROTAVIRUS VACCINE for Immunisation. It was a case of actual medication error due to expired vaccine used. 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. Documents held by sender: none
Patient had trouble seeing, high blood pressure and heart rate, dizziness, pain in back of head.
Two days after receiving my second Moderna vaccine, I developed a red itchy rash surrounding the injection site.  The red, angry rash meaures about 3 inches by 4 inches in size.  I making this report 4 days after receiving my injection and the rash is still present
This spontaneous report was received from a physician and refers to a 2 month old patient of an unknown gender. Concurrent conditions, medical history and allergies were not reported. On 27-MAY-2015, the patient was vaccinated a dose of VARIVAX (Merck) injection, 0.5 ml once, subcutaneous, (lot# reported as L001333), which was administered outside the prescribing information to the 2 month old of the patient. No adverse effects were reported. Additional information has been requested.
5-10min post injection: metallic taste in mouth 1 hr post injection: sudden dry skin, increased thirst, increased urination, pulse at mid 80s, oxygen saturation at 98 12hrs post injection: diarrhea for 1 hr 18hrs post injection: fever/chills , headache, dizziness & nausea develop; pulse increases to high 90s and oxygen dropped to low 90s 24hrs post injection: fever at 102.4-102.8, increased pulse, oxygen dropped to high 80s. 28-33 hrs post injection: pulse at low 100s, oxygen saturation between 86-90, squeezing chest pain on some beats, handheld ekg monitor detects multiple possible vpb RonT , blood pressure 128/68 45 hrs post injection: oxygen saturation in low-mid 90s, fever dropped to 100-101, No abnormal beats detected on EKG monitor. Nausea gone. 48-54 hrs post injection: fever drops to 99.
Information was received from a medical assistant referring to multiple unknown patients. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered doses of improperly stored ZOSTAVAX (lot# reported as M003488, expired date 27-MAR-2017) (dose and route unknown). The vaccines were exposed under 8.8 Fahrenheit degree (F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
lost hearing totally, hearing adi's; so painful; shingles 3 times, in hair and ears; This serious case was reported by a consumer via interactive digital media and described the occurrence of hearing loss in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles 3 times, in hair and ears). On an unknown date, the patient experienced hearing loss (Verbatim: lost hearing totally, hearing adi's) (serious criteria GSK medically significant) and pain (Verbatim: so painful). The outcome of the hearing loss and pain were not reported and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the hearing loss, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the hearing loss, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-Mar-2023 The case was received from the patient via interactive digital media. The patient never had them after having his/her 1st shingles shot now have had them 3 times (at the time of reporting), so painful and even in his/her hair and ears. The patient had lost his/her hearing totally getting hearing adi's made. The follow-up could not be possible as no contact details were available.
Information has been received from a doctor of pharmacy student concerning a 15 month old female who on 11/02/2001 was vaccinated with a dose of MMR II. Other concomitant therapy that day included IPOL, diphtheria/pertussis vaccine/tetanus toxoid and Prevnar. On 11/04/2001 the pt had swollen lymph notes that were reported to the clinic on 11/09/2001. There was no treatment or medication ordered. The nurse practitioner advised that the pt follow-up with the physician. The pt sought unspecified medical attention. It was also reported that on 11/09/2001 the pt was vaccinated with a dose of varicella virus vaccine live and subsequently had the same reaction (WAES0204USA03123). Additional info has been requested.
Vac administered at 10:30am yesterday. In Observation >10:45am.. no side effects at that time. While in a store buying flowers... approximately 11:45am... experienced sudden and overwhelming onset of profuse heat and perspiration. Eyeglasses immediately fogged up, perspiration ran down my back and ran under my face mask. I felt lightheaded and faint. My husband confirmed that my back was "on fire".   Last night, I was awakened by extreme chills and shivering... every muscle and joint tense and painful. This continued for some time and then I became feverish with bed cloths and bedding soaked. Had a temp of 102 @7:30 am with HA and muscle & joint pain.
I had the flu-like symptoms on 1/9/21 - body aches, headache, and jaw tightness. 1/10 = woke up with facial swelling, took tylenol, had 100.5 fever that night 1/11 = woke up with a HUGE face, lots of swelling - went to urgent care had a 101 fever, they sent me to GW ER  (facial swelling looked similar to MUMPS - I have been vaccinated)
pt recv vax 3SEP98 & pt exp elevated glucose levels;pt nl range is 100-175 & has been averaging 400 recently;
experiencing blood clotty like symptoms; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (experiencing blood clotty like symptoms) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for an unknown indication.    It was Unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 25-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (unknown route) 1 dosage form. On 01-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (experiencing blood clotty like symptoms) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (experiencing blood clotty like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received a dose of the Johnson &J vaccine on 25-Mar-2021 and had been experiencing blood clotty like symptoms. Then after that patient received Moderna Vaccine on 01-Nov-2021. No treatment details were reported.  Company comment: This spontaneous case concerns an adult patient of unspecified age and gender, with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Thrombosis (reported as experiencing blood clotty like symptoms) that occurred in the context of mRNA-1273 vaccine in COVID-19 vaccination series. Latency could not be assessed as the exact date of onset of event was unknown. Patient had previously received a dose of COVID-19 VACCINE JANSSEN. No further information on risk factors, medical history, concurrent condition, clinical course, concomitant medication, investigations and treatment received were provided. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Fever 101 deg on 01-09-08 24 hr. after immunization was given. On 01-10-08 AM - child developed abdominal pain and vomiting x1. Injection site was erythematous, warm and hard. Doctor diagnosed mild to moderate reaction. No fever on 1-10-08; Treatment: Ice and Tylenol
Constant tinnitus right ear only, similar to white noise x2 weeks. Mild vertigo and occasional nausea noted with position changes.  Urgent care visit 10/7/19 revealed no ear infection or wax build up.   Negative medical history, no changes in daily activities, negative allergy symptoms, or any possible exposure to loud noises prior to flu shot.
Sudden severe onset vertigo, completely debilitating and lasting for approximately 5 hours.  Subsided same evening.  Still left with lingering dizziness, bouts of pressure in ears and tongue tingling, and marked increase in consistent tinnitus.      I'm on a daily regimen now of ibuprofen and antihistamines, to keep the symptoms manageable, they return when I do not take it.   All of these symptoms are new, experienced after the vaccine (aside from the tinnitus).
25JUL95 pt c/o heart beeping & heart pain x 1;26JUL95 mentioned heart hurt x1;28JUL95 about 11AM c/o heart hurt & was having trouble breathing;couldn't take a full deep breath;chest pain-rxn to MMR;fever of 103.8;rash on chest & back;
Patient called hospital call center for advice after c/o  tingling sensation and shoulder/neck pain  on his left arm for 3 weeks. Pt received vaccine on 8/26/21 at outside institution facility.   Pt tried Advil and tylenol; but no relief. Pt went to ED to be reevaluated but eloped 9/17/21. Pt was then seen by urgent care provider on 9/18/21; provider unclear of pathogenesis of symptoms.  Pt had benign exam and no acute changes.  Neurology was consulted and plan was for referral to neurology for further follow-up.  Pt was given gabapentin PRN for pain and continue ibuprofen PRN or Tylenol PRN for analgesia. Provider gave pt ED precautions for any worsening symptoms.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history was not provided. On an approximately 12-MAY-2014 (reported as "about three weeks ago"), the patient received their first dose of VARIVAX (Merck) (dose, route of administration, lot# and expiration date were unspecified). No concomitant medication was provided. The physician stated that the patient was healthy. On an unspecified date in 2014 after the dose, the patient developed a varicella like rash "which was confirmed to be vaccine related chickenpox". The reporter stated that he was not the treating physician, and did not know the name of treating physician or any patient information. The outcome of chickenpox was unknown. The reporter considered the chickenpox to be related to VARIVAX (Merck). The patient sought medical attention. Additional information has been requested.
Reaction at injection site - red, hard, swollen, and painful for 5-7 days, then redness, slight bruising, and itching through current, but improving.
had the same reaction, she was shaking all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunisation. The following information was reported: TREMOR (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "had the same reaction, she was shaking all over".  Additional information: she said after her second shot of the Pfizer COVID-19 she had the same reaction, she was shaking all over and it went away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored PROQUAD (lot number K001854, expiry date 06-AUG-2015) or (lot number K0118144, expiry date 06-AUG-2015) (also reported as the healthcare worker could not identify the lot number) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the PROQUAD (Merck) underwent multiple supported temperature excursions. The action taken with the therapy with PROQUAD (Merck) was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with PROQUAD (Merck) was unknown. There was no product quality complaint reported. This is one of the many reports from the same source. Additional information has been requested.
Child came to office to recieve Bivalent booster - was given 0.25 mL, should have been given 0.5 mL child will retun in 2 months to get correct dose.
Information has been received from a female with a history of laceration and a September, 1997 diphtheria toxoid allergy resulting in muscle pain (myalgia) and inability to move her neck (neck disorder). In October, 1997, she was vaccinated with a dose of pneumococcal vaccine 23 polyvalent Concomitant therapy that same day included a dose of influenza virus vaccine. It was reported that "ever since she received these three vaccines" the patient has experienced a variety of health problems, including shortness of breath, flu-like symptoms, coughing w/out mucous, muscle spasms throughout her body, some swelling in her feet blurred vision, hair loss, enlarged lymph nodes, lots of chest pain, numbness in extremities and tingling in her extremities. The patient sought medical attention. Additional information has been requested.
Large red area at the injection site , fever of 103, nausea, vomiting several times.
Severe diarrhea which quickly brought on perianal hematoma along thrombosed hemorrhoids.    I was in so much pain I took Codine over the weekend before I could see a doctor on Monday.  I debated going to the Emergency room it was so bad.    It took me four weeks to begin to recover.  Only to be followed by diarrhea and massive internal hemorrhoid  the exact same amount of days after my 2nd dose.    Note my second Dose is the very same Lot # as first dose
pt recv vax & devel abscess-red ring around inj site;tx in ER;swollen lt arm-problem lifting, moving arm w/o pain;given ATB & something for pain;ringing in ears;sinus problem, head numbness;
The patient is a 64-year-old white male with complicated medical history.  He was initially admitted to Stonecrest on December 9th.  His course was significant for hypoxic respiratory failure, influenza A infection, and pneumonia.  He was given antibiotics.  He did not want intubation.    On January 6th, he was transferred to Select for further evaluation and management.  He required high levels supplemental oxygen with Vapotherm.  He was placed on BiPAP.  Antibiotics were continued.  DNR status was confirmed.  On January 8th, he expressed a desire to transition to comfort care.  Comfort care orders were placed.  He was pronounced dead at 12:47 p.m.  Family was at the bedside.
Low-grade fever, chills, nausea, muscle ache, extreme fatigue. Treated with ibuprofen.