chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bruising in chest; arm soreness; is bivalent False/administration date 11Jan2023 /dose number 3; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient received BNT162b2 (BNT162B2), on 11Jan2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single, Manufacturer unknown), for COVID-19 immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 11Jan2023, outcome "unknown", described as "is bivalent False/administration date 11Jan2023 /dose number 3"; CONTUSION (non-serious), outcome "unknown", described as "bruising in chest"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". It was unknown if therapeutic measures were taken as a result of contusion, pain in extremity.  Additional Information: Events were reported non-serious, did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating nor resulted to congenital anomaly/birth defect. It was unknown if patient had COVID prior vaccination and post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
3 hrs p/flu vax given pt exp coughing, gagging, diffculty sitting, weak, pale, clear nasal drainage, loud burp & rapid & shallow resp; acting funny; taken to ER; dx presyncope episode;
Just getting over it,It horrible, I was misarible; feeling miserable; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and feeling miserable. On an unknown date, the outcome of the shingles and feeling miserable were unknown.   It was unknown if the reporter considered the shingles and feeling miserable to be related to Shingles vaccine.  Additional details were provided are as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and had them. The patient stated that just getting over, they were horrible, get your shots. The patient stated he/she sure wish that he/she would of gotten his/her 2nd one, he/she was miserable. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K023532, expiry date 21-JUN-2016; exact dose was not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient  in post vaccine observation area. She came to nurse asking for help. Stated she did not feel well. Slightly pale. Anxious assisted to chair  and recliner brought to her. Assisted to recliner. Legs elevated and head lowered. Nurse stat called. BP taken.  BP 134/82.  Cold cloth placed on forehead. She stated she was feeling better. Nurse stat team here. Patient states she has a history of SVT. Was transferred to wheelchair and transported to ER.
Maculopapular rash on trunk and face and slightly on upper extremities with low grade fever that began slightly in the nuchal region on 9/21/10, with concern for spreading noted further on 9/22/10 and continuing at clinic visit on 9/23/10.
No adverse effect; one dose of improperly stored vacine; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On 05-NOV-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R036581 for prophylaxis.       On 05-NOV-2019, 1 day after onset of therapy the patient experienced product storage error.  On an unknown date the patient experienced no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).
Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingles vaccine and then got the shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Elevated heart rate. Irregular heart beat. Chest pain. Neck cramping. Headaches
Patient is a 90 y.o. female who presented from home on 9/11/2023 with back pain, weakness, found to have covid. Initially not on oxygen and family requested paxlovid which was started. Did require 1-2L NC with some wheezing on exam, started steroids with good response, able to wean off oxygen. Symptoms all improving. Family requested SNF on DC.    COVID-19 Generalized Weakness -Presented with: Weakness, back pain, increased cough. -Symptom onset: 9/11 per family (cough increased at that time) -Positive COVID-19: 9/11 at Hospital -Vaccination status: Vaccinated with Moderna and boosted with Pfizer with booster dose on 10/2022 -CXR on admission showed mild peribronchial thickening with no discrete infiltrates. -Oxygen status: up to 2L NC-> RA 9/14, started dexamethasone 9/13. Started paxlovid 9/12 when she was off O2, given this is a targeted treatment for covid / likely more beneficial than remdesivir, will continue paxlovid, off O2 on 9/14/23 -Serial COVID labs ordered: No -Case Management/Social Services consulted: Yes -Consulted PT and OT   Back pain, seemingly resolved -started mid last week, mainly right scapula per family, but now farther down back.  -+MSK TTP of back from lower cervical spine to mid thoracic, likely MSK in etiology -tylenol prn. PT/OT   Dementia -This is a known historical diagnosis. -Patient takes donepezil 10 mg nightly and memantine 1 -Continue home medications with formulary change to memantine. -Delirium precautions. CKD3A -Baseline creatinine of 1.3?1.4, confirmed with outpatient records. -Patient is currently at baseline. -at home on Macrobid, this was prescribed to her by her urologist and the patient has had good control of her UTIs as without that she has had significant issues with UTIs.  Appears the patient has had any side effects per discussion with the daughter given her decreased GFR at baseline. Plan to resume on dc   Chronic cough -Etiology unclear. Stopped lisinopril in the past without any benefit -Patient is on Flonase in the outpatient setting.  Also takes Tessalon Perles. -Continue Tessalon Perles continue to monitor.   HTN -Continue home lisinopril.   History of recurrent UTIs -Seen by outpatient urology.  Sees Dr.  -Last evaluated 10/2022. -She was placed on Macrobid for recurrent UTIs and has had good symptomatic control.
OFF LABEL USE; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a pharmacist concerned a 17 year old male. 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 not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced off label use. On 07-APR-2021, the subject experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate age at vaccine administration was not reported. This report was non-serious.
a male patient received an expired dose of Shingrix on 16Oct2023. The vaccine expired on 06Oct2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received Herpes zoster (Shingrix) (batch number PH2R2, expiry date 06-OCT-2023) for prophylaxis.   On 16-OCT-2023, the patient received the 2nd dose of Shingrix. On 16-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: a male patient received an expired dose of Shingrix on 16Oct2023. The vaccine expired on 06Oct2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2023 A pharmacist reported that a patient received an expired dose of Shingrix on 16th October 2023. The vaccine expired on 06th October 2023, which led to Expired vaccine used. The HCP did not have the patient's DOB. The expired dose was the 2nd dose in the series. HCP consented to follow-up via email.
appendicitis; sepsis; bowel burst; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 19May2021 12:00 (Batch/Lot Number: EW0171)(at age 53-years-old) as dose 2, single for covid-19 immunisation. Patient received the first dose on 26Apr2021 12:00 (lot number: EW0171) on the left arm at age 53-years-old. There were no other vaccine within four weeks. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication(s) included carvedilol (CARVEDILOL); digoxin (DIGOXIN); rivaroxaban (XARELTO); all taken for an unspecified indication, start and stop date were not reported. The patient experienced appendicitis, sepsis, and bowel burst on 22Sep2021 13:00. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for the events for 14 days. It was unknown if patient received treatment for the events. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
patient  started feeling dizzy and sweaty about 5 minutes after vaccine given and was sitting in chair and falling to the side.  I tried talking to her and getting her attention and she would look at me and then close her eyes like she was going to pass out.  She started talking to me and after a couple minutes then began to complain about a sick stomach and started vomiting and diarrhea on and off for about an hour.  Patient would seem to feel better but then vomit again. After about an hour she had us call her daughter to come get her to take her home. Daughter came to get her and she was still complaining her stomach hurt.  I called patients daughter a few hours later and she said her mom was still feeling sick and I told her to call her doctor or take her to the ER if she didn't start feeling better soon.
Itching at site of injection & Phlegm like feeling in throat. Took BENADRYL & felt fine.
Patient was admitted to the hospital on April 6 with superior mesenteric vein thrombosis.  Presented due to periumbilical abdominal pain lasting a week that has gotten worse.  Other risk factors for clots include 2 years use of oral contraceptives and the patient having a BMI of 38.
Itchy injection site; Redness at the injection site; Swollen injection site the size of a softball; A spontaneous report  was received from a 57-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced itchiness, redness and swelling like the size of a softball at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) in the right arm for prophylaxis of COVID-19 infection.   On 3 Jan 2021, after receiving the vaccine, the patient experienced itchiness, redness and swelling at the injection site. Treatment for the events is Benadryl.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events is Unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Joint and muscle pains in all hands and feet, constant tingling and numbness in left hand.  All symptoms are worse after eating even small amounts of sugar.  On several occasions, I experienced extreme pain and numbness in my hands and feet, and a fever several hours after eating foods with moderate amount of sugar (half cup of Costco ice cream, for example). These symptoms began one week after receiving the booster shot and have become progressively worse over time, peaking approximately 2 weeks ago.  I am able to manage these symptoms with very limited, anti-inflammatory diet (no sugar, very limited carbs) and liberal use of NSAIDs.
tongue became swollen; mouth inside is sore; teeth ache; This is a spontaneous report from a contactable consumer or other non hcp (Patient).     A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced side effect from vaccine received last tuesday, a few days after tongue became swollen, entire mouth inside was sore but has no sores and experienced teeth ache. The patient took Benadryl and it reduced the swelling a bit. The swelling was not life threatening or keeping from eating at this time. It was just uncomfortable to eat hard or salty foods. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Her "face hurt"; Sweating; Blurred vision; rash; Muscle aches; Achy joints; Vomiting; Chills; Headaches; High fever of 103.8 F; General tiredness; hives; A spontaneous report was received from a consumer concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt, low-grade fever.  The patient's medical history was not provided. Concomitant medications reported were Hailey 24 FE (birth control), Singulair, Zyrtec, Red Yeast Rice for drug use for unknown indication.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt, low-grade fever.  Treatment details included Tylenol and Excedrin.  Action taken with mRNA-1273 in response to the events was not reported.  On 8 Feb 2021 the outcome of events, rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt was resolved. On7 Feb 2021 the outcome of events, low-grade fever was resolved.
Swollen red area on entire upper arm. Warm to touch. Keeps progressing further to a larger area.
This case was reported by a physician and described the occurrence of aseptic meningitis in a 34-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2008 (approximately two weeks prior to reporting) the subject received unspecified dose of FLULAVAL (unknown). On 11 October 2008, within weeks of vaccination with FLULAVAL, the subject was admitted to the hospital with severe headaches that were worse on movement, vomiting and a fever of 100F. He had a CT scan and a spinal tap. He was treated for 24 hours with ROCEPHIN. Aseptic meningitis was reported. The physician considered the events were clinically significant (or requiring intervention). The subject improved and was discharged on 13 October 2008. He was seen by his physician on 17 October 2008 and was given a prescription for pain relievers for the headache symptoms. At the time of reporting the events were resolved. THE subject returned to work on 22 October 2008.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: 1320  Pt. S/P vac at approx 10 mins. c/o mild nausea and lightheadedness.  Pt, responsive, no LOC. Mucus membranes pink. Lungs clear to auscultation, HR 70 reg, No SOB, no diaphoresis present. RN instructed pt. to lower head between legs. 1320 BP 162/78 p67. States occas has elevated BP Pt. states has family hx of HTN. 1326 BP 173/80 P72. Sym of lightheadedness and nausea resolved at this time. Inst. to inc. oral fluid intake to 8-10 glasses H20 per day. 1330 Left obs area in stable cond.
1-2 hrs p/immun 8JUN93 pt devel urticaria generalized; PE 9JUN generalized urticaria & papular urticaria; 10JUN vasculitis hive changes;
Severe whole body hives; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 08:45 as dose 1, single (Lot number: Gj6738) at the age of 67 years, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 11Nov2022 as dose 1, single (Lot number: Uj934aa), in left arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient has no known allergies and no covid prior vaccination or other vaccine in four weeks. The following information was reported: URTICARIA (medically significant) with onset 13Nov2022 at 20:00, outcome "not recovered", described as "Severe whole body hives". The event "severe whole body hives" required physician office visit. Therapeutic measures were taken as a result of urticaria including Prednisone 40 mg per day. The patient was not tested for covid-19 post vaccination.; Sender's Comments: As per the available information the causality of the event urticaria with the suspect BNT162b2, BNT162b2 omi ba.4-5 can not be ruled out completely. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, Ethics committees, and Investigators, as appropriate.
At 2 months, received DTAP and pt had severe fussiness for 2 hours. Discussed holding pertussis but parent declined. Pt had a new onset a febrile seizure.
(I am breastfeeding.) That day, I started with a sore arm. by 8:00 pm sore to move or touch. (It took about three days to resolve the sore arm.) I had a headache. A couple hours after vaccine I was told I was exposed to COVID. Got tested on 31st - I tested positive for COVID. Got shortness of breath, the bad muscle ache, the loss of smell and taste; coughing, sore throat, headache; fever. I still have headaches and I still have some congestion sometimes. It is getting better but my sense of smell and taste aren't back. Fever, shortness of breath, cough etc lasted 10 days. I was out of work for two weeks. Called the doctor  (January 4th, 2021)- for Oxygen levels - were dropping - they were in the high 80's - the doctor let me stay home and monitor on my own as I have a nebulizer and inhaler at home.
I had my vaccination on 09/10/2022. On 03/09/2023 I I had symptoms of a urinary tract infection with frequent urination. I had a culture done which showed elevated white blood count and blood in the urine. I was given the prescribed an antibiotic. I haven't received my blood work back yet. I still have a few symptoms left on 03/13/2023.
Red and warm blotchy area at the site of injection that is approximately 5 inches by 2 inches.
Patient passed out after receiving vaccines. Elevated legs and put patient in supine position.  B/P taken 90/60, pulse 92, alert.  Patient was monitored for the next 45 minutes.  B/P stable at 110/70; pulse 88.  Discharged with brother at 11:45am.
NUMBNESS AND WEAKNESS IN SMALL FINGER AND RING FINGER ON LEFT HAND.  GOT THE SMALLPOX VACCINE IN THE LEFT DELTOID. I, THE PHYSICIAN, HAVE DONE A COMPLETE PHYSICAL EXAM AND HAVE NOTED A CERVICAL NERVE 8 RADICULOPATHY.
Patient developed a severe headache and tremors within 1 hour of receiving the MCV4 and MenB vaccines in the clinic.  Mom gave 1000 mg of Tylenol and was re-evaluated in the clinic by his PCP.  The patient's headache had started to improve and he had normal vital signs, and exam including neuro.