chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was very congested. I had nasal congestion as well. I also had coughing and a fever which progressed throughout the month. The fever wouldn't break, so they put my on antibiotics because it turned into a bacterial infection. After a few days, I was much better
Patient  called to report that  her arm has been very soar since 8 pm 12/04. She received moderna booster on 12/04. she took ibuprofen 800 mg for pain and she referred the pain beyond soreness to the point she can not lift her arm..
This spontaneous report as received from a registered nurse refers to a 8 weeks old infant. The patient's concurrent conditions, medical history and drug allergies were not reported. On 28-NOV-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Got varicella 11/7/2015 and started having some redness and today has a swollen, warm to touch red area around the injection site, not itchy, not painful, hasn't taken any OTC meds, no dyspnea/throat tightness/throat swelling/lip swelling/dysphagia/tongue swelling. R lat upper arm with a 5 cm in diam red swollen warm to touch area, not ttp, full ROM of his arm--good perfusion and sensation. Benadryl 25-50 mg orally every 4-6 hours regularly if not going to school otherwise Claritin or Zyrtec every morning daily as directed, and Benadryl 50mg at bedtime after rash resolves, warm heat and gentle massage for 20 minutes then cool compresses for 20 minutes 3-4 times a day, can use cool compresses/baking soda compresses or baths or calamine lotion for itching, inc fluids, return or go to ER if sx worsen otherwise f/u with PCP.
Moderna COVID-19 Vaccine EUA; I had an extreme adverse reaction that started a couple of hours after the shot: sore arm, vomiting, chills, fever, fatigue, muscle/body aches, and nausea.  The symptoms did not subside that evening and only got worse, so about 4:00 am the next morning I went to The Hospital. The Hospital gave me two bags of fluids for dehydration, nausea medicine, and did a full blood panel. I was discharged around 10:30 am. It took several days for me to start feeling better. However, about a week later, my left arm was still hurting and I developed a rash next to the injection location. The rash went away about two days later without treatment. About a week after that, my arm was still hurting so I called the urgent care and they recommended that I come in or wait it out, so I chose to wait it out and see if it got better. The pain did not go away, so I called the urgent care back and they made the appointment with my primary care doctor. My primary care doctor said my arm felt a little warm and he prescribed Voltren gel.  I used the gel and the pain did not stop, n fact it is now radiating down my arm and up my shoulder. If the pain does not go away by the end of this week, my doctor wants me to come in for further testing.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two months old male patient who received vaccine PENTACEL. The patients past medical history and family history were not provided. Concomitant medications included PCV 13 and ROTARIX vaccine on unknown date. On 30-Oct-2018, the patient received a 0.5ml dose of suspect PENTACEL lot C5440AA, expiry date 29-Oct-2018 via intramuscular route in the left thigh. It was an actual medication error case due to expired vaccine used. It was reported that patient child was vaccinated with PENTACEL on 30-Oct-2018 but the expiration date was 29-Oct-2018. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender- none.
Fully vaccinated, boosted on 11/2/21.  COVID infection breakthrough with inpatient hospital stay.
Resident was to receive Pfizer Bivalent Vaccine and was Inadvertantly given Pfizer Monovalent.
The pt went to MD about 1 hour after receiving shot. She had canker sores on left side of tongue that appeared. She received a steroid shot and then was on Prednisone and an antihistamine for 4 days. She didn't have any difficulty breathing. She ended up back to the MD with flu symptoms, 2 weeks later and then ended up with a sinus infection. The MD suspected that she had a virus in her system on the day she received the vaccine.
Patient reported having COVID arm (swelling, redness, pain, and warmth at the injection site).  The vaccination was not given here.  But, I wanted to document the it happened anyway.
Sore throat; Congestion; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion) had not resolved.        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.   Concomitant medications were not provided.  Post vaccination patient experienced congestion and sore throat, these symptoms worsen in the morning and lasted for couple of weeks .Treatment information was not provided.
Patient became lightheaded, flushed, tachycardic, and developed hives.  Patient was administered 25mg of diphenhydramine orally and observed.  Patient quickly began feeling better, hives disappeared.  The patient left with 2 other coworkers.
Right after vaccine was given, patient felt lightheaded. Pharmacist gave a bottle of water and ice pack, while his wife attended to him and waited for his recovery. Meanwhile his eyes rolled few times. His wife asked me to call 911. Medic came within 15 minutes and took him to hospital while he was still conscious.
Administered expired vaccine. Vaccine expired 9/30/2022.  Stability data supports the use of this product through Oct. 19 though so no further action is necessary.
EYES TURNED THAT COLOR AFTER JNJ JAB; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) 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 eyes turned that color after JNJ jab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of eyes turned that color after JNJ jab was not reported. This report was non-serious.
I got COVID-19 arm with a red, itchy bump that lasted for a week. A rash on my arm from wrist to under arm, right arm by hand and right foot. Used topical cream.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 at 15:45 as dose 1, single (Lot number: En629), in left arm, on 02Mar2021 at 15:45 as dose 2, single (Lot number: En6199), in left arm, on 29Nov2021 at 15:45 as dose 3 (booster), single (Lot number: Fj1620), in left arm and on 08Jun2022 at 19:45 as dose 4 (booster), single (Lot number: Fm7533) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukemia (watch and wait)" (unspecified if ongoing), notes: Chronic lymphocytic leukemia (watch, and wait); "immunocompromised patient" (unspecified if ongoing), notes: immunocompromised patient. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS], start date: 06May2022 and Miacinamide from 06May2022. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure.
Pain across my right foot, my instep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2022 (Lot number: FD7218) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2022, for Covid-19 Immunization, reaction(s): "soreness in the arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "Pain across my right foot, my instep". No follow-up attempts are possible. No further information is expected.
I believe I had a purple dotted rash on belly  on 3/14. Broke out in hives on 3/18 on arms, legs, trunk,.
This spontaneous report as received from a consumer via company representative concerning an unknown age niece. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 16-JUN-2018, reported as "a month ago", the patient was vaccinated with a second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The reporter mentioned that the patient fainted (syncope) after receiving the 2nd dose of GARDASIL 9, approximately on 16-JUN-2018.The reporter spoke with the nurse manager of the pediatric group who reported that the "provider stated that the everything medically appropriate being was done". The patient sought  unspecified medical attention and the patient received an unknown treatment for the adverse event. The outcome of the event fainted and the causal relationship between the event and therapy with GARDASIL 9 were not reported.
pt recv vax & <24hr p/vax arm @ site where DTAP given became red-swollen, hot, tender circumference of red area @ site size of baseball w/ sl edema;advised pt to cont APAP & cool soaks-comfort measures to seek MD care if condition worsens;
I was fine for the first 15-20 minutes. About 20-25 minutes later, I was driving home with my child and came to a stoplight. Some kind of rush started from my feet and rose up to my head. I described it as lightheadedness but it was actually a different feeling; almost like a jolt. My hands started trembling. I had to outline over and call my family to pick us up. I was nauseated the rest of the day. The next 2 days, I was okay. On the 3rd day, the jolts started happening again (once per day at any given time) and I started having panic attacks and anxiety. I even called my physician and went to urgent care on that 3rd day.  I haven't driven since because I haven't felt safe. 6 weeks, multiple doctor and therapist visits later,  I'm finally starting to feel "normal" again.
Vaccinated pt admitted with asymptomatic covid infection. No information available on type of vaccine, date, location, etc.
pt recv vax & had a petite mal sz;pt mom was advised to phone child's pediatrician & inform her of the incident;
I had a sore arm. In August I tested COVID. I had a lot of symptoms and got really sick. Fevers for 4 days, sore throat, lingering cough, lost sense of taste. In bed for entire week. I had head congestion in my head.
local site reaction with discomfort and worsening erythema, induration, and warmth later developing itching and I still have this topical steroid applied with resolution of most of the induration and warmth, some of the erythema and itching; in the last 48hours I have developed a second and much larger ring of erythema surrounding the central 3-4cm patch of erythema; the outer ring measures about 6-7cm in diameter; no other symptoms
pt received first dose of moderna on 8/27/21. pt experienced headache, fever, and chills that were gone within 3 days. pt then experienced itching at injection site that did not go away and would come and go. pt does not think anything else is related to the itching. pt says itching comes and goes but stopped about 5 days ago. Pt will f/u with md
pt recv vax 1975 & 1996  & antibody titer was tested p/each vax & showed no detectable antibody;
Currently, Janssen COVID19 vaccine is only approved under EUA for use in those 18 years of age and older. Patient was age 13 at time of immunization.   No treatment was given. Mother was informed that administration of the vaccine was a medication error and to contact their HCP with any concerns.
This spontaneous report was received from a nurse regarding unspecified number of patients who on an unknown date was vaccinated with GARDASIL. The nurse stated that unspecified number of patients were administered improperly stored doses of the vaccine. The outcome of the events was unknown. This case is linked to 1505USA008498 (same reporter link). Additional information has been requested.
This non valid spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapies were not reported. On 01-AUG-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX expiration date 27-JUL-2017 (dose, route, anatomical place of vaccination and lot# were not provided), for prophylaxis.
Left upper arm Adema and erythema overlying the deltoid area tender to the touch with small vesicles. Local topical hydrocortisone 2 1/2% and cold compresses advised along with protection of the area and pain medication
Intense chronic hives and dermatographism starting 13 days post booster shot.  No previous reactions to doses 1 and 2.  Hives responded to steroids (first round of Medroll, second round of Prednisone) but as soon as they tapered  the hives have come right back.  They continue to pop up spontaneously and intensely itch despite taking Allegra in the morning, Zyrtec at night, and Provide AC twice daily.
TC from pt mom stating pt awoke w/temp in the noc;temp @ time of call-10:15 was 102.2 axillary;mom states has given APAP & cool bath w/o results;
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 31-JAN-2013, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 05-MAR-2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
5:00pm on day of vaccine I began feeling a fever coming on.  I had a fever on and off for the next 24 hours.  With ibuprfen and tylenol, it never dropped under 99.4 until the following evening.  7:08pn 04/14 - I am feeling tingling in both my legs.  It is ongoing now for almost 2 hours.
Low platelet level. Platelets are normally over 150, after vaccination levels dropped to 110. Joint pain and rash near private area.
This case was reported by a healthcare professional and described the occurrence of influenza type A in a 29-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included AUGMENTIN and  Antidepressant (unknown). On 30 September 2010 at 15:00 the subject received unspecified dose of FLUARIX at 0.5 ml in the left arm. On 21 December 2010, 82 days after vaccination with FLUARIX, the subject experienced influenza type A (influenza test was positive). Symptoms included, fever (102), cough, body pain and headache. At the time of reporting the outcome of specific symptoms was not reported. Influenza was reported to be unresolved. These events were considered to be the result of vaccination failure according to GSK definition.
Pt was wanting her second shingles shot but received pfizer instead. Technician and Intern confirmed with pt that they were giving the covid vaccine. It was realized after her vaccine that she had already received both pfizer vaccines and it was actually the shingrix vaccine she was wanting.
Bruising at injection site, and redness of arm about 6 inches below the injection site. The patient states that the area is not painful or itching, just red.
Slight Fever, very tired, a headache/stiff neck for over 2 days.
This spontaneous report was received from a physician via a company representative refers to a 67 year old female patient. On 07-JUL-2009, the patient was vaccinated with a dose of ZOSTAVAX (lot# expiry not reported). On 07-JUN-2013, the patient developed shingles after receiving ZOSTAVAX. This patient had received the vaccine on 07-JUL-2009 and then developed a dermatone rash around her waist on 07-JUN-2013. Patient sought medical attention. The patient called her physician, was seen and examined in the office on an unspecified date and the physician then prescribed VALTREX and LYRICA to the patient to manage her symptoms. The patient recovered shingles on an unknown date in approximately 2013. Additional information has been requested.
Patient c/o headache and nausea at 7:00 PM on day of administration. Next day c/o Pain at injection site of left arm, could not move arm, and temperature 101. 3rd day Patient states she took Tylenol and fever went away, she could move arm better. 4th day all symptoms went away.
Swelling in arm in which the vaccine was administered as well as a bruised feeling but without any bruising. Patient was instructed by pharmacist to treat pain with Aleve to alleviate pain.
Monday-Feeling like ants crawling under my skin.  Headache, present even with Tylenol Tuesday- Ant feeling subsided, headache and neckache.  Lightheadedness and loss of balance.  Went to ER Thursday 5/20- Lightheaded and loss of balance  Since 5/4, lightheadedness comes and goes.  Light and sound affect the ability to focus.  I have never felt like this before.
Information has been received from a pharmacist concerning a 71 year old female inpatient with drug hypersensitivity to aspirin, COUMADIN and Metformin who on 05-FEB-2010, was vaccinated as a routine order before discharge while she was a patient in the hospital with a 0.5 ml dose of PNEUMOVAX (664000/0621Y). After the patient was discharged and was at home she developed redness and swelling of her arm at the injection site. This progressed to an "eaten away" area on her arm. The patient was readmitted to the hospital and was being treated with packing to the area and vancomycin. The reporting pharmacist requested a lot check for lot # 664000/0621Y. At the time of the report the patient had not recovered. This is one of several reports received from the same source. A lot check has been initiated. Additional information has been requested.
17x16cm erythema surrounding site of vaccine in (L) mid outer forearm. Onset was 1-2 hours after administration of vaccine.
This spontaneous report as received from a pharmacist refers to a 657 year old female patient with no drug reaction and no known allergies, and no pertinent medical history, who on 02-JUL-2013, was vaccinated with a dose of ZOSTAVAX 0.65ml, subcutaneously (lot # J001003, exp: 24-APR-2014) for shingles prevention. Concomitantly, the patient was on following therapies: unspecified stomach medication, unspecified blood pressure medication, unspecified anti-depressant and unspecified pain management medication. On 03-JUL-2013, the patient visited the pharmacist stating that she had redness and swelling at injection site. The patient also stated that there was a lump at injection site and the site was hot to touch. No treatment was given for the events. The patient did not visit her primary healthcare provider. The outcome of the events was reported as not recovered. The relatedness of the events to therapy with ZOSTAVAX was unknown. Additional information has been requested.
SLIGHT FEVER THAT NIGHT, EARS AND BACK OF HEAD RED.  WOKE UP NEXT MORNING AND STILL HAD FEVER AND HAD RED WELPS ALL OVER BODY.