chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Moderna Vaccine @ 11AM; Patient admitted to PCN allergy (hives). Pt monitored x 30 min post vaccine. Pt returned to common area @ 1:45pm c/o itchiness around eyes. After more history - pt states had "breathing problem w/ PCN" O: P70, O2 99% RR = 16 Skin no rash no hives no swelling
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination, the patient experienced a half dollar sized amount of redness around the injection site for weeks.
Day 1 - 3 after vaccination: body aches, fatigue Day 3 painful, red hot inflammation below injection site developed, 2 x 3 inches in area, no blistering  Day 4 rash is not subsiding, fatigue continues. This is the day I am reporting side effects
22APR96 pt states swelling @ site >fifty cents piece, itching, redness, hot to touch
Swelling, rash, SOB 30 min after immunization. DECADRON 8mg IM/BENADRYL 12.5mg IM. O2 sats x2 improved with meds.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX (batch number T1501326 ?, expiry date unknown) for prophylaxis. Previously administered products included BCG vaccine, Tuberculosis vaccine, cholera vaccine, typhoid vaccine, smallpox vaccine, Flu vaccine (high dose) and SHINGRIX (1st dose, refer case US2018140211). Concurrent medical conditions included neck injury, penicillin allergy and sulfonamide allergy. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, erythema of extremities, tiredness and sleep disorder. On 2nd August 2018, the patient experienced generalized rash and measles-like rash. On an unknown date, the outcome of the pain in arm, swelling arm, erythema of extremities, tiredness, sleep disorder and generalized rash were not recovered/not resolved and the outcome of the measles-like rash was unknown. It was unknown if the reporter considered the pain in arm, swelling arm, erythema of extremities, tiredness, sleep disorder, generalized rash and measles-like rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had lots of vaccinations in the past with no reaction. She was not allergic to latex and she sleeps on right side. The patient received SHINGRIX in the left deltoid. The patient felt that the shot was given a little higher in the left deltoid on her 1st shot compared to her 2nd shot. On Wednesday morning, she woke up with pain in the upper left arm which did not restrict her movement. She said the arm was still swollen and a little red in the shape of a square at the injection site. She felt tired and napping on 1st August 2018, 2nd August 2018 and on the day of reporting. She reported that this was abnormal for her as she usually did not feel tired and did not normally nap. The nap on 2nd August 2018 was a 4 hours nap. She said she was too tired to take a shower and stayed in her pajamas all day on 2nd August 2018. Around 7:30 or 8 pm on Thursday 2nd August 2018, the patient noticed a rash on her body that looked like measles. It covered her entire back, trunk, neck under her chin, under both arms, below belly button down to pubic hair, under the breasts. The rash did not itch. It was flat, not raised and not flaking. She said if she closed her eyes and felt where the rash was vs. where it was not she could not feel a difference. She did not make dietary changes and no detergent changes. She reported that the rash was still present on day of reporting and in all the same places but was not quite as bright red as on 2nd August 2018. The patient had denied permission to contact her physician. The reported batch number T1501326 ? for SHINGRIX does not exist in sales database. Clarification is requested for the same.
On May 3, 2022 I did not feel well but I thought I had a sinus infection. I was on vacation and the pollen count was very high. By May 5th both my sister and I did not feel good at all. I got home from the trip on May 11, 2022. I normally feel tired because of my MS but this felt like a different kind of tired and my muscles ached and I was bruising easily. I did a home test for COVID on May 13, 2022 it was positive. I do feel that my symptoms are moderate, I thought about going to the ER because I did not feel right but did not go. Now 12 days later I feel like I am getting better. On May 16, 2022 did another home test and I tested negative.
Patient noted crepitus (air under the skin at the injection site) and was evaluated in the Emergency Room.
TESTED POSITIVE; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive was not reported. This report was non-serious. This report was associated with product quality complaint : 90000209406.
I started having chills, aches, headaches, and fatigue. I took Tylenol and it seemed to help. In February, I started having severe neck pain and all of my joints hurt. My right arm began to go numb and tingle. I couldn't use my right arm to life anything. I have motor weakness in my right arm now. I am being treated for neuropathy right now.
Left arm began to have hives, swelling, rash, and pain in left arm and face that gradually worsened hours after administration. By the next morning, the patient had swelling and  in the face that had continued swelling and pain continued in the left arm. Mother treated patient at home with OTC Benadryl twice and made office visit for assessment the next day. Benadryl was administered in the office again and the provider prescribed Cetirizine 10mg to take orally at bedtime every night for X 10 days. Reviewed if symptoms worsened or of great concern to seek medical attention.
T99.7 inc warmth @ local rxn site (4x4 cm); Seen in ER 23AUG91 w/t101.4 & 3cm red warm area lt deltoid;
This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent condition and concomitant medications were provided.  On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # reported as L035637, expiration date: 08-JUN-2017, dose was not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AEs; a patient was administered PROQUAD on 01/04/2023 after a temperature excursion; This spontaneous report has been received from a registered nurse referring to a patient of unspecified age or gender. Information of concurrent condition, pertinent medical history, concomitant medications and drug reactions/allergies was not reported.  On 04-JAN-2023, the patient administered with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection (lot# W019624, expiration date reported as 18-NOV-2023, but upon internal validation established as 19-DEC-2023; dose, route of administration, anatomical location and strength were unknown) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions at -14 degree Celsius (?) up to -10 ? (-13.6 ?) for 72 hours (product storage error). There was no previous temperature excursion. No additional adverse event (AE) was reported (no adverse event).
Within 30 sec post/vax, pt c/o lightheadedness, put in Trendelensburg, as B/P cuff applied. Notices sl raised rash at site of shot & on anterior lateral torso & on opposite arm. Tx'd with Benadryl 25mg,IM, with resolution of rash.
Initial s/s at 9AM 6/5/09 "a kind of stiff neck, lightheadedness"; tenderness at injection site.  2pm on 6/5/08: T. 101.9; mom said on way to clinic.  Mom called after visit: PA gave 50mg of BENADRYL, bed rest; Dr. f/u - pt ok resting, recommended TYLENOL (T-100.7) and to f/u with urgent care or ER if needed.
Information has been received from a 60 year old female consumer with multiple sclerosis, leukemia, allergies to iodine, and AVONEX, with a history of chemotherapy who on 13-DEC-2007 was vaccinated in the right arm with a dose of Zostavax (Oka/Merck) (lot # 658396/0967U).  Concomitant therapy included ALTACE, PAXIL and PROVIGIL.  She reported that after she received the vaccine (December 2007) she developed a headache.  Medical attention sought and outcome in regard to the headache was not reported.  She also reported that 2 days after the vaccination (December 2007), her arms swelled up, and she had blisters that started to itch.  She reported that she would scratch them open but they would not get infected, and were not filled with pus.  On an unspecified date, she developed a rash on her face, scalp, shoulders, and the tops of her legs.  She described the rash as bumps that looked like they were underneath the skin everyday and every 4 to 5 days they would "break out and scab".  She was evaluated by a dermatologist and underwent diagnostics that included: a "swab" of the blisters "(ruled out chicken pox"); and an unspecified "biopsy for shingles".  The patient indicated that since "having leukemia and chemo, she has had no immune system" and had not recovered.  A product quality complaint was not reported.  Follow up information from a physicians assistant indicated that the skin biopsy obtained by the dermatologist revealed non-specific dermatitis and did not confirm herpes zoster or any varicella related rash.  At the time of this report, current patient status was not reported by the physician assistant.  Follow-up information from the consumer indicated she was still covered in "these blisters" and neither her physician or dermatologist could tell her what they are.  This is one of three reports received from the same source.  Additional information has been requested. 06/24/08 This is in follow-up to report(s) previously submitted on 3/26/2008. Follow-up information from the physician assistant indicated that the patient has an odd rash: It was a fine papular rash when she saw the patient. The rash is more diffuse now, but was still present. The physician assistant reported the patient indicated the rash is vesicular at times. She asked the patient to come in during a vesicular time to obtain a specimen. The patient also stated her arms swell and get tiny blisters on them. The symptoms come and go with no apparent cause or reason and her back "feels like it is on fire". This is one of several reports received from the same source. Additional information is not expected.
Had Moderna booster at noon and by 7:00 p.m. I had extreme body aches, chills. Next morning high temp and worst headache, worst body aches, or sore throat that I've ever had. Dehydrated so received fluids and pain meds from urgent care. Same thing on Sunday but MD decided to run labs. Troponin 281, d-dimer 3.93, abnormal EKG, C-reactive protein 99.6, ESR 56, low rbc, hematocrit, hemoglobin, platelets. Ambulance to hospital. Diagnosed with double pneumonia, IV antibiotics for 3 days 02 in the 70s lots of wheezing.
The patient is a 75 y.o. female patient of a CNP with history of HTN, HLD, multiple hernia repairs, asthma, recent admission for ileus and bronchitis(dc 3/28) who presented to the Medical Center with cough, wheeze, dyspnea, generalized weakness, N/V/D.   Acute hypoxemic respiratory failure Covid-19 Virus Infection Community acquired pneumonia Dyspnea, hypoxia requiring 4LNC Multifactorial due to COVID and pneumonia CT chest in ED with dependent opacities atelectasis favored vs PNA; also nodule  Date of onset of COVID symptoms: 3/11 Date of covid positive test: 4/4 Vaccination status: vaccinated Imaging: As above Oxygen requirements on admission: 4L Current oxygen requirements: RA Urine antigen neg, sputum cx mixed flora Medical therapy: steroids, rocephin, and zithromax; started remdesivir as GI symptoms consistent with new COVID Consultants following: none  Anticipated special isolation end date: 4/14 Home oxygen evaluation completed and no home O2 needs identified; discharged on RA   Ileus Dx last admission; improved since Returns with GI symptoms again; although could all be COVID-related KUB on admission ileus vs mild bowel obstruction Passing BM's; last was 1d PTA Tolerated regular diet Continue bowel regimen   AKI Cr up to 2.02 on 4/5 from baseline ~1 Likely prerenal due to GI losses Continue hydration for now  SCr improved to 0.80 on 4/8   Steroid-induced Hyperglycemia BG ~100-200 since admission Likely due to steroids Monitor for now   Lung nodule RUL 1.7 cm nodule seen on CT, with borderline enlarged R hilar mediastinal LN Rec recheck CT in 3 months, PET-CT or tissue sampling  Generalized weakness Myalgia  Due to current illness Uses a walker at baseline Re-assess after treatment Mobilize as able Muscle aches likely related to COVID Norco prn ordered    HTN Holding home hydrochlorothiazide and losartan for AKI Continue home Norvasc and clonidine    Hx of Paradoxical VCD Hx of Polypoid corditis ENT consulted previous admission discovered 3/14 Laryngeal control therapy breathing exercises and outpt ENT f/u
Narrative: COVID infection following COVID vaccine series 06/30, Moderna , dose #1  06/02, Moderna , dose #2 12/23 COVID swab, result: detected 12/20 pt cc: cough, fever, myalgias, exposure: unknown 12/23 SARS-COV-2 Variant Sequencing: pending
Rash on my right breast; This is a spontaneous report from a contactable consumer (patient). A 63-years-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, in the right arm on 26Mar2021 at 13:00 (at the age of 63-years-old) as dose 1, single for covid-19 immunisation. Medical history included she had radiation for cancer (neoplasm malignant) a year ago in the right breast. Lymp nodes removed. Prior to vaccination patient was not diagnosed with covid-19. since the vaccination the patient had not been tested for COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 28Mar2021 at 04:00, the patient experienced rash on my right breast. The patient did not receive any treatment for the event. Outcome of the event was recovering.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Pt to ED 4/18 for GI bleeding and altered mental status, pt awake and continues to be confused, pt is A&O x 1. 4/20 pt without new complaints; feeling better; no chest pain/palpitations, stable. 4/27 Sepsis BPA firing, but pt remains A&Ox3-4 and showing no s/s of distress. 5/1 Pt Magnesium still low, replacement done with Mg Sulfate 1gm IV x 3 doses per electrolyte replacement. 5/2 No acute complaints, denied being in pain. 5/4 pt A&Ox3 with some forgetfulness, VSS on room air, with no change in the pt assessment, pt s/p bone marrow biopsy.  5/8 pt Sepsis BPA fired for a score of 9. Due to temp of 100.3, HR 113, and WBC being 18.5. Pt tolerated procedure well. 5/13 Pt c/o cold symptoms, COVID+, discharged 5/13.
Muscles aches, tireness, body pains, chills, hot flashes, pounding headache, difficulty moving, thrist, lose of appetite.
Blurred vision; itchy eyes; Burning eyes; Rash on face; muscle soreness to the extent that he feels like he just ran a 20 mile race; weak; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), DIZZINESS (Dizzy), VISION BLURRED (Blurred vision), EYE PRURITUS (itchy eyes) and EYE IRRITATION (Burning eyes) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced ASTHENIA (weak), DIZZINESS (Dizzy), RASH (Rash on face) and MYALGIA (muscle soreness to the extent that he feels like he just ran a 20 mile race). On 03-May-2021, the patient experienced VISION BLURRED (Blurred vision), EYE PRURITUS (itchy eyes) and EYE IRRITATION (Burning eyes). At the time of the report, ASTHENIA (weak), DIZZINESS (Dizzy), VISION BLURRED (Blurred vision), EYE PRURITUS (itchy eyes), EYE IRRITATION (Burning eyes), RASH (Rash on face) and MYALGIA (muscle soreness to the extent that he feels like he just ran a 20 mile race) outcome was unknown. Not Provided      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.
11 hours after my 2nd shot- chills, hot flashes and sweats, body ache, headache, fever of 103.9 for 34 hours. Then body ache, chills, hot flashes and sweats, lightheaded, blood pressure very low. Then, all of these symptoms and blood pressure high. Followed by a day of lightheadedness and sweats, then a day of Vertigo with headache and vomiting. I am on day 8 with fatigue and hot flashes and chills.
they have a receipt that stated that they received a 0.25ml dose, but the nurse told them that she gave him the 0.5ml dosage And they believe that is correct; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (they have a receipt that stated that they received a 0.25ml dose, but the nurse told them that she gave him the 0.5ml dosage And they believe that is correct) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 001m21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (they have a receipt that stated that they received a 0.25ml dose, but the nurse told them that she gave him the 0.5ml dosage And they believe that is correct). At the time of the report, INCORRECT DOSE ADMINISTERED (they have a receipt that stated that they received a 0.25ml dose, but the nurse told them that she gave him the 0.5ml dosage And they believe that is correct) outcome was unknown.            No concomitant medications was reported. It was reported that patient had a receipt that stated patient received a 0.25 ml dose, but the nurse gave the 0.5 ml dosage and nurse believe that it was correct, and that there was no problem with that vaccination. No treatment medications was reported.
Thi spontaneous report as received from a 65 year old female patient with seasonal allergies. On 07-OCT-2014 the patient was vaccinated with ZOSTAVAX injection (route, dosage, dose number and lot number unknown). Concomitant therapies included lisinopril (manufacturer unknown). The patient reported experiencing on 08-OCT-2014, redness, a rash, itchiness, a lump 'the size and shaped of a chicken egg' and feeling hot at the injection site after receiving ZOSTAVAX. The patient sought medical attention (office visit) but received no treatment. The outcome of the events was reported as recovered on approximately on 22-OCT-2014 (reported as: about two weeks later). Additional information is not expected because there is no permission to contact physician.
Received Pneumovac vaccine in AM and began having severe pain in same arm a few hours later. Says pain was a "10" unable to sleep. Today 11/3/06 pain is an "8". No redness, no swelling, no fever. Says pain felt like a knife digging in arm. Encouraged to take usual pain med-Tylenol. Continued pain thru 11/06/06-warm compresses helped relieve pain.
Received dose on 9/3/2021. Had some mild headache, lightheadedness days following. But early October, developed petechiae of lower extremities that eventually progressed to nose bleeds and heavy period. Was evaluated officially on 10/13 when patient showed her mom the lower extremity rash. Platelet count noted to be 2. Given course of steroids and rechecked on 10/15 with improvement to 3, but with improvement in heavy period as well as nose bleed. I am now admitting her for IVIG after discussion with pediatric hematology.  Improving with admission platelet of 6.
Burning, tingling sensation all over my back and on various parts of my upper body that comes and goes. Most noticeable and painful at night, but not every night.