chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she felt like she had Urinary tract infection; tongue swelling; unable to swallow; rash; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of urinary tract infection in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EA4RB, expiry date 04-FEB-2025) for prophylaxis.   On 25-OCT-2023 15:00, the patient received Arexvy (intramuscular). On 26-OCT-2023, 1 days after receiving Arexvy, the patient experienced urinary tract infection (Verbatim: she felt like she had Urinary tract infection), swollen tongue (Verbatim: tongue swelling), unable to swallow (Verbatim: unable to swallow) and rash (Verbatim: rash). The patient was treated with macrobid (nos) (Macrobid), steroids nos (Steroids) and prednisone. The outcome of the urinary tract infection, swollen tongue, unable to swallow and rash were unknown.   It was unknown if the reporter considered the urinary tract infection, swollen tongue, unable to swallow and rash to be related to Arexvy.     It was unknown if the company considered the urinary tract infection, swollen tongue, unable to swallow and rash to be related to Arexvy.   Additional Information: GSK Receipt Date : 27-OCT-2023 The reporter stated that patient received Arexvy on Wednesday and on Thursday, she said she felt like she had urinary tract infection and had a supply of Macrobid which she took at 4pm. At 7pm that night she developed tongue swelling, she was not able to swallow, and developed a rash and went to the ER. The ER gave her steroids and discharged her on prednisone this morning. The reporter was not sure if she was admitted or if she remained in ER. The reporter consented to follow up.
The patient had a bruise develop the night she received the vaccine. The next day and the day after that two red circles developed on each side of the bruise. The bruise when I saw it on 04/18/2019 was dark black/blue in color and the size of a half dollar. The red spots on each side of this bruise were very red and the size of a baseball. They were also warm to the touch. She did go see a NP who said an infection had developed from the vaccine and was prescribed a 10 day course of BACTRIM DS for this infection.
Patient stated after receiving the 2nd dose of Pfizer 04/14/2021, she started experiencing symptoms of confusion and intense left shoulder pain. No noted primary visit/communications.
She had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She had a sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D2-1A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (She had a sore arm). At the time of the report, VACCINATION SITE PAIN (She had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported stated she received vaccine in the left arm as her doctor stated not to do it on her right arm because of breast cancer. No Treatment medications provided.   This case was linked to MOD-2021-287461 (Patient Link).
At 7:54 am, patient received Hep A (2) vaccine. He was normal at the time of vaccine (no reactions). Patient sat in the waiting room post-shot after approximately 15 minutes he stated he felt dizzy- he stood- walked for a few minutes and then indicated to us he was dizzy. We administered O2, muffin and juice. Pt. recumbant for 15 minutes until symptoms subsided.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment given to patients. The vaccines was stored in freezer, take out one to two vials and place in fridge each day as needed.
Quickly progressing facial paralysis after extreme ear pain on same side of face. Diagnosed as Bell's Palsy. Extreme case per doctor. Some loss of taste. Persistent extreme pain in and around ear and traveling down neck; all same side. Eye won't close. Difficulty drinking, and difficulty eating without choking. Numbness on entire right side of face with full paralysis. Treatment is Valacyclovir, Gabapentin, Prednisone, Tramadol. And keeping eye covered at all times.
Developed a rash about one hour after vaccines, started on face and spread to trunk, lasted about 8 hours. At 4 month  vaccines, did not receive Rotateq and did not  develop a rash.
4/9/05-Present. Pt is forgetful, hyperactive, and clumsy. Pt was referred to Dr (neurologist). The impression was encephalopathy secondary to MMR vaccination.
Pt experienced a headache, ranging from a dull ache to extreme pain since 2 1/2 hours after immunization. Persisted since 4/10/00.
No adverse event; Received Expired Bivalent booster beyond 12 hours post puncture; Vaccine administered more than 12 hours after the initial vial puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Bivalent booster beyond 12 hours post puncture), PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after the initial vial puncture.) and NO ADVERSE EVENT (No adverse event) in a 15-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022 at 11:30 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Bivalent booster beyond 12 hours post puncture) and PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after the initial vial puncture.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Bivalent booster beyond 12 hours post puncture), PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after the initial vial puncture.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Bivalent booster beyond 12 hours post puncture) and PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after the initial vial puncture.).    No concomitant medication details was reported. It was reported that individual vial was used and vial size was 2.5ml. On 26-OCT -2022 the vial was initially stored in the refrigerator. Vial was first punctured on 26-OCT-2022 at 10AM. Vial was in the refrigerator the entire time for greater than 24 hours. Vial exposed to room temperature for greater than 24 hours. The vial did not undergo any temperature excursions.  No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-665658 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665658:Same reporter
THROBBING LEG PAIN/LEGS SORE TO TOUCH; STOMACH UPSET; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: naproxen sodium. On 22-MAR-2021, the subject experienced stomach upset. On 10-APR-2021, the subject experienced throbbing leg pain/legs sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach upset on 24-MAR-2021, and had not recovered from throbbing leg pain/legs sore to touch. This report was non-serious.
Assessment/Plan      Patient is a 74yo male with PMHx: HTN, DM Type 2, Obesity & STOP BANG 5 OSA + who is seen this morning for shortness of breath. He was directly admitted to the Medicine service after being transferred from the Hospital for sepsis, confusion and respiratory distress.  #Sepsis  #Leukocytosis  - unknown source at this point  - Vanc/Zosyn, Blood cx pendiing  - Trend CBC, CRP, Procalcitonin  - IV LR@150mL/hr  #AKI  - initial Creat. - 1.46/eGF 47  - probable pre-renal variant  - increase hydration  - minimize nephrotoxic drugs  #DM Type 2  - POC BG 269  - Lantus 8U, SSI, CC, CC Snacks  - Hgb a1c pending  - Metformin (Home)  #HTN  - Avg BP 110-120/50-70  - Lisinopril, HCTZ - Propranolol, Chlorthalidone (Home)  - Continue to monitor  #Obesity, morbid  - BMI 42.7  - OSA STOP-BANG score: 5
Began with flu like pains.  Woke up later in afternoon and I was delirious.  Did not know where I was .Asked concierge to arrange my transport to my home. I was at my only home.  Not able to control urine release. Unable to obtain or hold glass of water. Could not find my phone or remote control. Severe tiredness, confusion and fright.   Lasted approximately 18 hours with slow recovery and awareness. Returned to normal status within 24 hours.
Information has been received from a physician concerning a 49 year old Caucasian female MA with a heart murmur who on 11/16/01 at 15:00 was vaccinated with a 1st, 2nd and 3rd dose of Hep-B vaccine recombinant (yeast) (10mcg (IR) GL/MD) and according to the physician was "doing fine". The pt sought unspecified medical attention. The MA reported that on 11/16/01, she had dizziness and fever initially, "only that day". That night, she had pain at the injection site. She also had a headache for 1-2 days after injection and had constipation that lasted for 2 weeks. She stated that none of the adverse events "lasted". No further info is expected.
1/21-1/22/23 had redness/swelling/pain left arm, resolved by 1/23/23 1/27/23 had recurrence of redness, swelling, and now itchiness in same area of L arm. As of 1/30/23 swelling resolved, still has 3cm area of erythema and some itchiness.
Myalgia lethargy, not sleeping well, runny nose, labored breathing that has improved Narrative:
The patient reports having vertigo 24 hr after getting the vaccines. She also report that she got vertigo before but no like this.
Administration error 74 year old patient received 0.5 ml dose of vaccination which was supposed to be 0.3ML based on the vaccine dosage guide.
pt recv vax 2 doses of vax NOV95 & DEC95 & MAR96 a varicella titer was less than 0.86;no further details were provided;
Arm warm; Arm sore; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING HOT (Arm warm) and PAIN IN EXTREMITY (Arm sore) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Arm warm) and PAIN IN EXTREMITY (Arm sore). At the time of the report, FEELING HOT (Arm warm) and PAIN IN EXTREMITY (Arm sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-019502 (Patient Link).
Sore right arm where I received the shot. Swelling and soreness in my shoulder. Sore neck.
Pt. states that after receiving the 1st dose of J&J 03/11/2021, started experiencing symptoms 03/18/2021 of night sweats, leg weakness and shaking, vision loss, leg cramping, fatigue, and muscle aches. Emergency Room visit 10/04/2021, Blood Work and Observation. Pt. continues to experience symptoms.
Tightness in throat, headache, dizziness, numb in arm, tingling in throat. BP 145/76, HR 84. Recovered and released in stable condition
Treatment of COVID-19; Treatment of COVID-19; Patient was pregnant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 30 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies and no other medical history. Date of last menstrual period: 09Sep2022. The patient is expected to deliver a baby(s) on 16Jun2023. There were no concomitant medications.  The following information was reported: MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious) with onset 09Sep2022, outcome "unknown", described as "Patient was pregnant"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid-19 treatment included Paxlovid from 11Nov2022 to 16Nov2022. Patient was pregnant with Gestational period of 11.
Vaccine exp. use by date = 10/7/22 8 weeks after defrost exp. date = 10/31/2024
Red, itchy, painful and swollen area extending approximately two  inches beyond injection site in all directions. Whole-body fatigue and intermittent body chills as well.
Discussed with patient's mother that incorrect dose amount of Moderna 23/24 6m-11 given on 10/25/23. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's mother expressed understanding and indicated patient had mild fever the day following immunization, but is doing well. Instructions provided to monitor patient for additional or prolonged side effects and contact clinic with any concerns. Additionally, a message sent to patient's PCP informing them of error.
Information has been received from a physician's office and an office manager concerning a 66 year old male patient with no known drug allergies and no adverse events following prior vaccination who on 13-NOV-2000 was vaccinated with a first dose of PNEUMOVAX 23 and on 13-APR-2010 was vaccinated IM in the left deltoid with a second 0.5 ml dose of PNEUMOVAX 23 (Lot# 664864/1365Y) at 08:30. On 13-APR-2010 at 20:00, the patient experienced redness and swelling (cellulitis) of the left arm from shoulder to elbow/forearm. On 14-APR-2010 the patient called the office stating that the arm was red and swollen. The patient then came into the office later in the day on 14-APR-2010 and was given an oral prescription (name and manufacturer unspecified). By 15-APR-2010 the patient called the office again stating that now the arm was burning. The patient came into the office and was sent to the emergency room (name, address and phone number unspecified) because the patient developed cellulitis and at the emergency room the patient was given an IV antibiotic (name and manufacturer unspecified). The office manager stated that the patient was back in the office yesterday on 20-APR-2010 but she did not know the patient's status. On 21-APR-2010, the patient had recovered. Additional information is not expected.
Patient had initial vaccination and experienced bilateral joint pain within a few hours that persisted for around 1 month. Patient did not consider this an issue as it is a common side effect with her vaccination site soreness. Patient received second dose on 01NOV2019 and on 02NOV2019 experienced paresthesia and tremors in all extremities. This was ongoing for around 1-3 hours consistently. Patient is currently asymptomatic.
This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a adult patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. This case described the second nurse's adverse event. The reporter told that 1, 2 or as many as 3, was not even sure, nurses who had the FLULAVAL QUADRIVALENT vaccine experienced side effects outside of clinical trials. On 23rd January 2018, the reporter spoke with nurses at a clinic and the reporter reported some nurses experiencing possible adverse reactions with FLULAVAL. The patient experienced feeling unwell or malaise. The unrelated questions from the physician were sent to Agency, but that these events had not yet been reported to safety or the Regulatory Authority. This was 1 of 3 cases, reported by same reporter.
Within 5 minutes of vaccination patient was sweating, flushed, and nauseous. She did previously report she did not like shots and had felt the needle go in when her dose was administered. Was given a cool compress, cold water, and layed down on some chairs for observation. Patient quickly recovered and was feeling normal in less than 10 minutes.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A currently 62-year-old female patient received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at the injection site 11 hrs after vaccination on an unspecified date with outcome of recovered. The patient took TYLENOL and felt much better and no longer had pain. The information on the lot number has been requested.
She started having symptoms later the same day she got the flu vaccine. Says she was feeling really warm inside and broke out in a rash all over her trunk area. Mom states the next morning the rash had spread all over; from her neck down to her mid thigh area. Dr examined her on 9/19/17, she had an extensive scaly papular rash with a Christmas tree like appearance pointing towards midline.
vaccinated with an open vial from 13-Jul-2022 that was not discarded; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with an open vial from 13-Jul-2022 that was not discarded) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 vaccination.     Concurrent medical conditions included Specific allergy (drug) (Sulfa Drugs).    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with an open vial from 13-Jul-2022 that was not discarded). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with an open vial from 13-Jul-2022 that was not discarded) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient received the Moderna COVID-19 vaccine booster dose (unknown which booster dose it was) and no side effects had been reported. The reporter had no information on patient's past vaccination history. The events did not cause the patient to seek medical care (office visit, Urgent care, ER, hospitalized).  The vial was initially stored in the refrigerator on 11-Jul-2022. The vial was first punctured on 13-Jul-2022. The vial stored in refrigerator post puncture and the vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius= 46 degree to 77 degree Fahrenheit) was seconds (long enough to draw a vial) and it was reported that the vial did not exposed to room temperature for more than 24 hours.  No treatment information was provided by the reporter.
Patient felt throat was itchy and dry.  Difficult to swallow.   Same happens when she gets a bug bite.  Takes Benadryl at home for relief.  MD prescribed one time dose of Benadryl, which was given in clinic.   Vital signs as follows:  190/89, sat 100%, HR 85, temp 98.6 ; follow up VS:  160/106, sat 100%, HR 84.   Pt remained in clinic for 30 minute observation and felt better prior to going home.  Will self assess her BP when relaxed at home and report to her primary physician.
Pain starting an hour after the injection (injection was at 2:30 pm 4/30/2019) Swelling starting  the next day , pain continued Redness was noticed two days later, pain slowly decreasing
She recieved her first Recombivax on 9/16/05 in the right deltoid. 20 minutes later the entire right arm started to tingle and go numb. Examination showed spasm in the posterior deltoid, sensory loss but no motor change. She was treated with celebrex and a pulse dose of medrol. Improved withint 24 hours and then had intermittent symptoms over 1-2 weeks. I thought the problem might have been a result of vaccine location or administration error so I personally gave her a second recombivax in the left deltoid without immediate incident. However, 15 minutes later she developed dysethesias, paresthesias and then numbness in the entire left upper extremity. Again there was no motor weakness. She did not respong to celebrex or an ice pack. Another pulse of medrol was given and symptoms resolved over 16 hours.