chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had some vaginal bleeding. I went to doctor on 7/26. On the 20th, they tell me I have uterine cancer. I went to see the specialist a week later and I had surgery; total hysterectomy on 8/27/2021. No other treatment yet. I will go for genetic counseling on the 27th. Defective RNA possibly. I am having preventive radiation treatment sometime in October in process with treatment. They said they got it all, but I think he sewed me up wrong so I'm having problems. I might have a hernia or something; all of the incisions have healed well, but there is one area which is painful and tender.
I have been having random lightheadedness, shortness of breath, fatigue, random blacking out spells. I also have had weird thing with my heart rate, it goes 130 resting and also goes down to 50. when it racing at at resting I feel dizzy, sweating and tingles in random places in my body and 2 minutes later it will drop to down to heart rate of 50. I have an echocardiogram schedule on Sept 8, 2021 with Cardiologist. One day I passed out at work had to go to ER they did recorded I had a low heart rate.
Storing Moderna vaccine in their refrigerator and administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021; Patient administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021) and PRODUCT STORAGE ERROR (Storing Moderna vaccine in their refrigerator and administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Storing Moderna vaccine in their refrigerator and administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021) and PRODUCT STORAGE ERROR (Storing Moderna vaccine in their refrigerator and administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The BUD date was reported as 01-Nov-2022. and CDC expiration reported as 19-Mar-2022.  No treatment information was provided.
Extremely tired and sore around entire body. Difficulty moving, staying awake, walking, etc.
This case was reported by a nurse via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter agreed to be followed up. The case US2018GSK138898 was identified as duplicate of case US2018GSK138896. Case US2018GSK138898 would be deleted and all future correspondence will be added in the case US2018GSK138896 which stands as case of record for this patient. This case was also linked with US2018GSK138801, reported by the same reporter.
pt was given pediarix instead of recommended pentacle. pt received shot with a standalone hep b vaccine as well.
Beginning shortly after receiving the 2nd vaccine, I've been having hip pain/a general achy discomfort in my hip joints that continues to shoot down my left leg. I have not gone to a doctor for this. I am just reporting it in case others are experiencing and to have this possible side effect logged.
28 y/o female who presented as walk-in to clinic reporting development of itchy red rash over bilateral hands evening of 6/16/2009; possibly spreading up right forearm today. Received AVA#2 & repeat SPV (right deltoid) 6/7/2009. Initial SPV given 5/2/2009 resulted in equivocal take. She denied fever, chills, systemic symptoms; was well prior to & day of vaccinations; denied sick contacts, other environmental exposures, no prior hx eczema, atopic dermatitis, immunosuppression, or HSV; is otherwise well, not on medications; no known allergies to drugs, foods, latex, insect stings; she has had natural VZV infection in childhood. Pt was seen 6/17/2009 with non-urticarial patchy maculopapular rash over bilateral dorsal surfaces hands with faint erythema on palms, no vesicles; SPV site right deltoid consistent with major take/scab, no surrounding erythema, edema, or satellites, mild right axillary lymphadenopathy; treated with antihistamine & noted dramatic improvement within 24 hrs later. On 6/18 she reported similar but milder eruptions over bilateral dorsal feet & lateral ankles, but completely resolved by 6/19; as of 6/19 she reported mild hyperpigmentation over dorsal hands only - palms clear; no new eruptions; as of 6/23, no recurrence.
lower body pains; knee pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (lower body pains) and ARTHRALGIA (knee pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concomitant products included Methotrexate for Rheumatoid arthritis.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN (lower body pains) and ARTHRALGIA (knee pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (lower body pains) and ARTHRALGIA (knee pain) outcome was unknown.        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.
Ache down (L) arm and up neck. Redness at inj site. Warmness at inj site.
Information has been received from a health professional concerning a 5 yr old female with no pertinent medical history and no drug reactions/allergies who on 19Apr06 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot 649233/0996P). Concomitant therapy that day included a dose of poliovirus vaccine inactivated (Ipol), diphtheria toxoid (+) pertussis acellular 3 component vaccine (+) tetanus toxoid (Infanrix), hep b vaccine, recomb (lot 649802/0946P) and varicella virus vaccine (lot 652557/1024R). On 02May06 the pt experienced rash which was itchy, red and fine on her trunk, arms and legs. She was afebrile. No treatment was recommended at that time. The rash then increased in size and changed in appearance and increased it itchiness. On 05May06, the rash extended to her face and became a red consolidated rash with itching. On 05May06, she presented to the health dept. At that time she was not acutely ill. She did have a rash that was fine, mild, and contained to her trunk. The health dept felt that the rash was caused from a change in fabric softener. Since the health dept did not have a medical team, she was sent to the ER, where she was treated with prednisone and released. It was noted that the rash was not vaccine related by the physician in the ER. On 10May06, the rash was disappearing. She was noted to be recovering at that time. The reporter and the ER physician felt that the experience was not vaccine related. The event was considered to be an other important medical event by the reporter (OMIC). Additional information has been requested.
patient reported that approximately 3 hours after receiving the vaccine her face broke out in hives, and was hot to the touch, this lasted all night but went away the following day, patient was deferred from the 2nd shot until cleared by her physician
Dizzy immediately after shot , 2-3 weeks of rash and hives  2 weeks of prednisone
Mom reports infant irritable for 2 days after immunization on 11/07/2001 lasting 2 days. Rash appeared on 11/12/2001. Rash blotchy, head to toe. Denies any raised areas or swelling. No other symptoms. Irritability increased. ER visit on 11/12/2001. Was told rash was reaction immunization. Told to give Benadryl. States Benadryl given every 4 hours for 2 days. Noticed improvement after first day given. States ER MD advised continue with routine immunizations.
Information has been received from an unspecified reporter referring to an 11 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 10-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Diffuse allergic reaction with urticaria, mild difficulty breathing the next day, right upper arm swelling.
Patient was given covid vaccine dose 1 and 2 at outside facility. She received dose 1 on 1/12/21 Moderna vaccine Lot #025J20A. When she went back to the same facility on 2/9/21 for her 2nd dose she was given Pfizer vaccine Lot #EL1283. She came to the Facility for a booster dose and was given 3rd dose on 10/9/21 Pfizer vaccine Lot #ER8735. The patient did not have an adverse reaction to any of the 3 doses and has not tested positive for COVID that we are aware of. Relevant medical history: Lung adenocarcinoma T1aN0M0-stage IA s/p segmentectomy 9/2017 & completed vaccine series with different manufacturer
This spontaneous report as received from nurse practitioner via company representative refers to a patient of unspecified demographics. Patient's medical history, drug reactions and allergies were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX, dose, lot number and expiry date were unspecified. Concomitant therapy was unspecified. On an unknown date, the patient developed rash after receiving ZOSTAVAX vaccine. No product quality complaint was involved. The outcome of event rash was unknown. The reporters causality assessment for the event rash with the therapy of ZOSTAVAX was not provided. No further information was provided. Additional information has been requested.
pt recv vax 16OCT97 & dx w/GBS on 30DEC97 to 17FEB98;prior to GBS dx in good health;no med problems;NKDA;started w/course of ATB on 22DEC97 for pneumonia P pleurisy;
woke up this morning (2-5-10) pain in RT arm. slight swelling, slight redness. advised pt to use warm compresses, TYLENOL/MOTRIN pain. To call me Monday. 2-8-10 10:30 spoke with pt. much better. Resolved.
Pt. started having pain and swelling  at the injection site week after the administration of the vaccine.  Pt. used ice bag ti reduce the swelling. There were some redness at the site also.
Moderna 0.25ml booster dose given 25.5 hours past initial vial puncture. No adverse effects; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna 0.25ml booster dose given 25.5 hours past initial vial puncture. No adverse effects) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 043B21A and 002B21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Influenza (Manufacturer- Fluad,  Lot Number- 312835, Route- IM and Body site- L Delt Dose number- 1). Past adverse reactions to the above products included No adverse event with Influenza. Concurrent medical conditions included Allergy to antibiotic (azithromycin), Drug allergy (gabapentin) and Penicillin allergy.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna 0.25ml booster dose given 25.5 hours past initial vial puncture. No adverse effects). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Moderna 0.25ml booster dose given 25.5 hours past initial vial puncture. No adverse effects) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Significant Follow up- Event date, dose 1 and 2 details and co-suspect details were added.
patient received an unreconstituted (diluent only) dose of Menveo; patient received an unreconstituted (diluent only) dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 33-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA977A, expiry date 31-MAY-2024) for prophylaxis.   On 15-JUN-2023, the patient received Menveo. On 15-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received an unreconstituted (diluent only) dose of Menveo) and inappropriate dose of vaccine administered (Verbatim: patient received an unreconstituted (diluent only) dose of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 It was reported that patient received an unreconstituted (diluent only) dose of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Patient was age 12 at the time of vaccination but received a Pfizer vaccine for ages 5-11 by accident.
Trouble speaking slurred speech, twitching in arms and legs, muscle weakness, fatigue, and irritable bowel, and walking. Doctor thought stroke, but test came back negative,  Weak muscles and falling.  Seeing a neurologist they suspect ALS. Appt. 5/15/13 for official diagnoses.
First pain lying on left arm. Then after around less than 3 months after pain when down to elbow and now cannot hardly use my left arm cannot even hold my phone up to my ear. Pain is constant. No improvement.. just there all the time
Pt got two vaccines and then saw podietry who gave her steroid pack. She had acute change in personality with visual/auditory Hallucinations. She has tingling, poor eye ccontact, and is bothered by benign  nodes  She is not sleeping well.
acute granulomatous tubulointerstitial nephritis; This literature-non-study case was reported in a literature article and describes the occurrence of TUBULOINTERSTITIAL NEPHRITIS (acute granulomatous tubulointerstitial nephritis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TUBULOINTERSTITIAL NEPHRITIS (acute granulomatous tubulointerstitial nephritis) (seriousness criterion medically significant). At the time of the report, TUBULOINTERSTITIAL NEPHRITIS (acute granulomatous tubulointerstitial nephritis) was resolving.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  The patient was treated with an unspecified steroids showed rapid improvement in kidney function.  Company comment-This literature non study case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected, serious (Medically significant) event of Tubulointerstitial nephritis (reported as acute granulomatous tubulointerstitial nephritis) that occurred about one month after a booster dose of mRNA-1273 vaccination. It was reported that patient had no clinical evidence of renal injury after the first two doses of vaccine. Renal dysfunction was incidentally observed about month after the booster dose of vaccine. The patient responded to steroids with rapid improvement in kidney function. No further clinical information was available for medical review. Outcome of the event was recovering at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Same day experienced heart racing and palpitations on a regular basis, usually every 40 min.- 1 hr.  Since that first day, heart has felt enlarged.
Had varicella on 4-8-08 SQ in L thigh which later swelled with edema & became red.  Area continues to swell more and is "hot" to touch - mom to take child to MD 4-11-08.
pt recv vax 17JUL95 & 1APR97 pt devel chickenpox w/20 to 30 pox;pt recovered from exp;
patient stated prior to vaccination that she has many allergies and has had anaphylactic reactions in past to aspirin, penicillin, motrin, yellow dye #5 and Iv contrast dye.  writer called Dr to discuss benefit vs. concern for reaction.  he advised for patient to receive 50 mg benadryl at 1250 and then be vaccinated.  vaccinated her at 1258 and by 1305 complaints of itching and visible hives. walked patient to er room 1 met by nurse.
This spontaneous report as received from a physician via company representative refers to a 2 month old female patient. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with ROTATEQ (dose, frequency, lot # and expiry date were not reported) orally for prophylaxis (reported as pediatric schedule) along with "other unspecified vaccines". On an unknown date the patient experienced irritability and unspecified gastrointestinal symptoms and the patient was hospitalized twice at an unknown location on unknown dates for the events. On an unknown date (reported as after 11 days) the patient's polymerase chain reaction (PCR) was only detectable for ROTATEQ (Antibody test negative). It was reported that the patient received unspecified treatment for the events. The outcome of the events was unknown. The relationship between the events and ROTATEQ was not provided. No product quality complaint was involved.
Reports nausesa and vomiting that lasted the morning and not feeling well the rest of the day.
redness about 2 1/2 " diameter around injection site w/mild itching  & site warm to touch /  still present / mild discomfort only did not apply any treatment
Information has been received from a female patient who on 14-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). The patient reported that after receiving ZOSTAVAX (Merck) she had been experiencing laryngitis and a sore throat. It is unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. No further information is available.
Vaccine administered in April 1, 2021.  Symptoms started April 2 with fatigue.  Extreme fatigue and body aches persist  nine days later. Nurse Practitioner said  she suspects Pfizer vaccine caused myalgic encephalomyelitis.
Onset one hour after receiving vaccine, experienced severe pain in shoulder and elbow of arm that received immunization; decreased range of motion due to pain; NO swelling or redness present.
Medication Administration Error. Patient received Moderna primary series vaccine instead of Moderna bivalent booster.  Patient notified of error and may return to clinic after 2 months for bivalent vaccine.
Hives on trunk within 2 minutes of injection 3 ml of Benadryl given PO. Hives had subsided by the time the pt left over 1 hour.
patients were given expired PENTACEL with no reported adverse event; Initial information was received on 13-Aug-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (Reference number- 00723367).  This case involves a 6 months old female patient who administered expired (expired product administered) DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (lot number and expiration not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 03-Aug-2021, the patient received a third dose 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (frequency: Once, Strength: standard, lot number: UJ343ABA and expiry date: 22-Jun-2021) via an intramuscular route in the right thigh for prophylactic vaccination.  It was of actual medication error due to expired vaccine used (latency: same day).  It was reported as "Caller reported that 2 patients were given expired PENTACEL. Caller requesting a copy of AE (adverse event) report be forwarded to her email".  At the time of reporting, no adverse event 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 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.
Information has been received from a physician, via a company representative, concerning a patient who on an unspecified date was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 649697/1038P). "Within the last 2 months", the patient developed "redness and swelling of the arm where the injection was given". Subsequently, on an unspecified date, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Pt reported a bad headache and a fever that started the evening of the same day as receiving the vaccine. The symptoms resolved by the next morning.
Chest pain (midsagittal), feeling similar to heartburn, pain felt midsagittal throughout chest, but especially immediately below heart. Diaphragm movements when breathing increased severity of pain. Symptoms subsided within 12 hours with use of Kwan Loong Pain Relieving Oil. Unlike heartburn, nothing worked to relieve pain immediately. This was in addition to known side-effects that were present including: fatigue, slight fever, headache, muscle pain, and soreness at injection site.