chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diffuse erythema around injection site, Warm to touch, non tender, and no induration. Caregiver told to place a cold compress for 20 minutes, to injection site every 1-2 hours for 24-48 hours. May also give oral Tylenol for pain. Patient was assessed by Dr., and she concluded patient was experiencing a local reaction to the vaccine.
This 17 yo female with an allergic reaction to Varicella in Lt lateral arm (due to Varicella injection subcutaneously. Has redness, pain and edema (L) arm.
mixed the powder vial with a sterile diluent; Wrong diluent Menveo given to adolescent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adolescent patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-Jun-2022 Reporters comment: The patient received a dose of Menveo where the powder vial was mixed with sterile diluent instead of the liquid contents in the second vial that was sent with the kit. The reporter consented to follow up. Additional Supportive Information: The patient received Menveo which was not mixed correctly that led to the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
PARALYZED; This spontaneous report received from a consumer 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, batch number: unknown and expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient paralyzed. Reporter stated that "I bet he does not come here and see my friend who is paralyzed from the vaccine." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralyzed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220121326-COVID-19 VACCINE AD26.COV2.S- paralyzed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Headache, Diarrhea, NauseaVomiting, pain at injection site, chills, fatigue  Narrative: employee states: 8/18 pain at injection site, headache, nausea 8/19/21 fever, headache, vomiting, diarrhea, chills, fatigue, pain redness and heat at injection site 8/21/21 diarrhea, nausea, headache, pain and redness at injection site 8/22/21 diarrhea, nausea, pain and redness at injection  site
developed shingles on approx 2/12/21, about  2 weeks after 1st covid vaccine
Pt. states that reactions began hours after receiving vaccines. She reports having tingling of both arms, a generalized rash on her arms and torso, and a sensation of swelling of the tongue. Pt. states she went to her PCP the day after receiving vaccines, no further action was taken by the PCP. Pt. states symptoms subsided throughout the second day after receiving vaccines.
pt with hx of recent hospitalization for Pneumonia; has been on ABX; brought to ED via ES for SOB and hypotension; O2 saturation 70% on RA per EMS; c/o abdominal pain, nausea, vomiting; CXR shows left lower lobe pneumonia; IV ABX started; given Levophed for hypotension; positive for COVID; septic shock; acute hypernatremia, acute hypokalemia; acute renal failure; pt's condition worsened requiring intubation with mechanical ventilation; condition deteriorated more; family transitioned pt to DNR with comfort measures; extubated and pt passed away in the hospital
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history included gastrooesophageal reflux disease. On 24-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # M042849, expiration date 18-JAN-2018, one dose, subcutaneously for prophylaxis. Other suspect therapies included sterile diluent (lot# L025375 and expiration date 14-MAR-2018). On an unknown date in July 2017, the patient experienced injection site induration, nausea, headache, malaise, injection site erythema and injection site pain. The outcome of injection site induration, nausea, headache, malaise, injection site erythema and injection site pain was not recovered. The relatedness between the events and suspect therapies was not reported. Additional information has been requested.
everything came back; major discomfort; felt bad Saturday/felt bad Sunday; really sick/felt sick all over/ like she "had some kind of disease"/extremely sick after receiving the vaccine; very weak /was not flu-like; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick/felt sick all over/ like she "had some kind of disease"/extremely sick after receiving the vaccine), ASTHENIA (very weak /was not flu-like), DISCOMFORT (major discomfort), SYMPTOM RECURRENCE (everything came back) and FEELING ABNORMAL (felt bad Saturday/felt bad Sunday) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension. Concurrent medical conditions included Illness on 23-Jan-2021, Asthenia on 23-Jan-2021, Discomfort on 23-Jan-2021, Symptom recurrence on 28-Jan-2021 and Allergy (fosamax). Concomitant products included LISINOPRIL and METOPROLOL for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ILLNESS (really sick/felt sick all over/ like she "had some kind of disease"/extremely sick after receiving the vaccine), ASTHENIA (very weak /was not flu-like) and FEELING ABNORMAL (felt bad Saturday/felt bad Sunday). On 25-Jan-2021, the patient experienced DISCOMFORT (major discomfort). On 28-Jan-2021, the patient experienced SYMPTOM RECURRENCE (everything came back). At the time of the report, ILLNESS (really sick/felt sick all over/ like she "had some kind of disease"/extremely sick after receiving the vaccine), ASTHENIA (very weak /was not flu-like), DISCOMFORT (major discomfort), SYMPTOM RECURRENCE (everything came back) and FEELING ABNORMAL (felt bad Saturday/felt bad Sunday) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Fever: fluctuating between 99° and 100° and lasting about 24 hours (noted 7-8 hours after vaccination, fever broke and returned at least three times overnight). Chills: first noticed 6-7 hours after vaccination and remaining for duration of fever. Muscle Aches: in vaccinated arm starting slowly at injection site about 4 hours after vaccination, growing to notable full-body aches within 8 hours of vaccination. Pain level estimated at level 8 within 18 hours of vaccination. Notable full-body pain remained approximately 48 hours, notable arm pain remained approximately 96 hours. Could not move vaccinated arm at the shoulder joint without severe pain from 18-48 hours after vaccination. Medication: 2 extra strength tylenol taken 24 hours after vaccination and continued twice daily for 3 days.
Pt. call day after shot (greater than 24 hours) reporting swelling, hot, redness, and itching at site. Stated swelling was significant. Advised to go to immediate care. Pt. came into pharmacy on Sunday. Large round, red, slightly raised area on arm. Pt. didn't go to IC and picked up BENADRYL.
became symptomatic on 06/06/2021, PCR positive 06/11/2021.
Fatigue; Chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.   A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history was not reported.Previously patient received BNT162b2 was taken as dose 1 for covid 19 immunization. Concomitant medications were not reported. It was reported that Caller was reporting feeling fatigued and feeling chills. Had just gotten the second dose a little under a month now and started to feel the chills and fatigue. He knows that it was a sign of his body fighting some kind of infection. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Developed severe acute right arm/shoulder pain on May 3 with loss of shoulder movement. No history of trauma or injury. Physical examination significant for right scapular winging. Diagnosed with long thoracic nerve palsy. Treated with oral steroids for almost 2 weeks and NSAIDs. Pain resolved with therapy but shoulder movement remains impaired.
PATIENT IN PHARMACY TODAY 3/3/21, COMPLAINING OF HARD KNOT WITH REDNESS, WARMTH AND SWELLING AT SITE OF TDAP INJECTION ONE WEEK AGO.  PATIENT STATES THAT THE AREA WAS LARGER AND HAS DECREASED IN SIZE. IT NOW MEASURES 1 INCH.  UPON ASSESSMENT, LEFT DELTOID HAS A VISIBLE AND VERY PALPABLE  I INCH IN DIAMETER  NODULE WHERE INJECTION WAS GIVEN.  NO RED STREAKS DOWN ARM VISIBLE, NO FEVER.  NO MUSCLE STRENGTH LOSS IN THAT ARM AND HAS FULL RANGE OF MOTION. PATIENT DOES REPORT RUBBING THE  AREA QUITE FREQUENTLY IN THE LAST TWO DAYS AND TAKING ADVIL.  ENCOURAGED HER TO MONITOR AREA FOR WORSENING REDNESS , MONITOR TEMP, CONTINUE ADVIL AND CALL MD FOR POSSIBLE OFFICE VISIT TO RULE OUT INFECTION.
Pt stated that he had achiness and low grade fever 11/09 that went away after taking tylenol. He reported 11/11 that he had an infection and renal failure and is in treatment at an ER. He attributes this to Pneumovax 23.
This is a spontaneous report from a contactable pharmacist, who reported events occurred to her daughter and her son (twins) with meningococcal group b rlp2086 vaccine. This is the first of two reports. A 18-year-old female patient received a single dose of TRUMENBA, intramuscular in left arm, deltoid muscle, on 11Jul2016 at 10:00. No other vaccine was given on same day. The patient was vaccinated at the pediatrician's office. Relevant medical history included asthma. Concomitant medication included VENTOLIN as needed, for asthma. On 11Jul2016, the patient experienced body ache, night sweats, sore arm and low grade fever. On 12Jul2016, the patient developed also diarrhea; and on an unspecified date, in Jul2016, there was an aggravation of her pain. No treatment given for the events. She was feeling better except her very sore arm. The events, body ache, sore arm and low grade fever related to meningococcal group b rlp2086.
Felt migrating heat/burning sensations off an on to the left arm after first vaccination which would come and go. After the first vaccine my heart rate elevated for about a minute with pounding, which I was evaluated for and then it subsided.  Two weeks after vaccination, a burning sensation returned to my left arm (where I had been vaccinated) and the sensation would come and go for the following two weeks. After my menses, I noticed that I started to feel hot sensations to both of my upper arms, which I then noticed to my upper back and neck. I questioned whether I should get the second vaccine and was not sure where the symptoms were coming from. I have never experienced anything like this before. I questioned if it was an anxiety symptom. I had the second vaccine and my right index finger and thumb briefly went numb, my heart rate elevated for a couple of minutes and then subsided.  The burning sensations  then became worse and the burning became so intense that it kept me up at night. Sensations have since also been felt to my low back, sides of hips and down the legs. I had an acupuncture treatment and was started on herbs which helped significantly so I could sleep. I also established a visit with an MD to explain my symptoms and was told to come back in a few days to have labs drawn.  The symptoms have not gone away. These sensations affect my work as I am a healthcare provider and need the use of my hands.  It has now been over two weeks and my symptoms have not gone away. Now I have migrating sensations that move all over my body which elicit a feeling of burning.  It seems that the sensations become worse as the day goes on and that they are not as prominent in the morning.
Pt was given 3 vaccines today: MENACTRA, ADACEL and GARDASIL given in that order. Immediately after GARDASIL was given. Pt had a vasovagal reaction with syncope. Pt was lowered to a laying position (from sitting). Episode lasted approx. 30 sec. Pt came to and began to cry. No treatment was needed. Pt stayed in clinic to be observed for 30 mins.
Patient was given Pfizer Bivalent Booster for his first shot in the series.  Had not been vaccinated for COVID before 11.21.2022. Called CDC and they stated to have him come back in 3-8 weeks to recieve the Pfizer Monovalent and then 2 months to receive the bivalent COVIS second series vaccine.  Patient had no known adverse symptoms from getting the COVID booster.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored doses of LIQUID PEDVAXHIB (incorrect product storage) lot# M047666, expiration date: 24-OCT-2019 for prophylaxis (strength, dose, frequency, and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Data logger was involved. The outcome were unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Patient had swollen arm and redness.  She went to clinic and they told her she had cellulitis
Pt recv vax on 2/16/99; on 2/17/99 pt exp swollen/ warm/ problems w/ ambulating leg; tx=cool compress
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 years old adolescent patient and unknown gender. On 21-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient experiences large, red rash on arm starting near the site of injection and spreading through arm. Patient went to urgent care and saw a provider who prescribed Cephalexin 500 mg , 1 capsule by mouth twice daily and cetirizine 10 mg, 1 tablet by mouth once daily.
Patient is reporting red itchy rash, pain and tenderness, burning from injection site down to elbow.  She is unable to put pressure on arm.  Her arm is swollen
12 days following my 1st vaccine I developed persistent hives on my torso, arms and legs. Two days prior to my 2nd vaccine I saw Dr. He indicated he was certain the hives were from the vaccine but that I should take Allegra the night before and the morning of the 2nd shot which I did on May 5, 2021. He indicated I could continue w the Allegra as a preemptive measure against a recurrence. I chose not to as I dislike taking medication if I don?t need to. Twelve days after the 2nd shot the hives returned and I have suffered w them daily ever since. They got so bad that I started the Allegra 24 on May 29.  The hives persisted even w a single dose of Allegra 24. I spoke to a nurse in Dr.'s practice on June 7 and she advised that I should take 2 24 hour Allegra?s each day until I experienced no hives for a few days saying it could be up to 4 weeks. While I haven?t been absolutely consistent taking the meds as I am terrible at medication, I am approaching the 4 weeks and am still having outbreaks of hives mostly on my torso. I have no underlying conditions and no known allergies. I had Covid 19. I was exposed on Feb 18 and tested positive on Feb 24. My only symptom was loss of taste and smell that came at about 1 week in.  I. Treated it with Alpha Lipoic acid and low dose Flonase and my senses returned. Some Lingering  impact is a fading of those senses over the course of a day some days.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (lot #, expiration date, site and dose were not reported). A week later (date unknown), the patient came back into the office with a rash. The physician stated that he did not believe it was shingles. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Addition information has been requested.
Got Pneumonia shot and she is in a lot of pain and red/tender. Pt. received shot in our office this week. Spoke to Dr. who stated if it is a localized reaction patient is to apply heat, take TYLENOL, BENADRYL, and except pain x 2 days. If symptoms are non localized, expanding past injection site, patient needs to be seen. Called patient, who is a nurse; she reports she is not having a localized reaction. Patient reports severe pain earlier, redness is in the front of her shoulder. Pain is from clavicle down to elbow. No arm swelling. No fever. Patient states she took an IBU and about 1 hour later she was 50% better. Advised patient she needs to be seen. Patient states she is going to wait until tomorrow and if she continues to have problems she will be seen.
Varicella vaccine administered to pt 2/1/06. 2 inch red raised area noted on outer part of left upper arm 2/12/06.  Febrile 2/14/06-100.7-101. Two small papular pruritic lesions on right chest. Prescribed Benadryl after 6 hrs PRN and Tylenol PRN.
Pt received his first dose of Covid vaccine (Pfizer) on 22 Jan 2021.  The member moved from one place to another where the only option for receiving Covid at the time is Moderna.  Pt denies any adverse reactions after receiving his second dose on 5 Mar 2021.  Only symptom was soreness in his arm at the injection site.
son tested positive for COVID 19 and has full symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (son tested positive for Covird 19 and has full symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced COVID-19 (son tested positive forCOVID19 and has full symptoms). At the time of the report, COVID-19 (son tested positive for COVID 19 and has full symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was scheduled for second dose on 30-Aug-2021.  No concomitant medications was reported.  No treatment drug details was reported.
On 07/18/19, 67 yo F presented to clinic for annual wellness visit. During this visit, pt was ordered and administered Pneumococcal Conjugate 13-Valent (Prevnar 13) vaccine in right deltoid (NDC: 0005-1971-02, Lot #Y03623, exp: 3/31/2021). RN reported "Patient developed warmth, redness and pain to upper extremity post immunization. Symptoms persist 5 days after injection." No documentation of this reaction within the pt's chart. No report of any treatment interventions. RN indicated that "Appointment scheduled for examination". Unknown when this appoint is scheduled.
Dizziness, nausea, headache, stayed there for an extra 20 -30 min while they checked my vitals and made sure I was ok.
Headache, Myalgia, Arthralgia,  fatigue Narrative:  missed work following second dose due to symptoms
Tightness in the throat, cyanosis. Walked to Emergency Department. Almost intubated. Tx with Epipen, SOLUMEDROL, BENADRYL. Ongoing weakness in the legs, dizziness.
She got a Knot at the injection site and now it has spread; Cough; She didn't feel good and slept all day; She didn't feel good and slept all day; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on 26Feb2021 (at the age of 74-years-old) as dose 2, single for COVID-19 immunization. Medical history included none. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN9581; Expiration Date: May2021), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced tiredness on late night on 26Feb2021, she didn't feel good and slept all day on 27Feb2021, cough on 28Feb2021 and she got a knot at the injection site and now it has spread on 02Mar2021. Outcome of Tiredness was resolved on an unspecified date, outcome of She didn't feel good and slept all day was unknown. Outcome of Cough and she got a Knot at the injection site and now it has spread was not resolved.  No follow-up attempts are possible. No further information is expected.
1/25/22 pt presents to ED after recent hospitalization at a local HCF for pneumonia and pleural effusion; dc'd to home with ABX; pt saw PCP today for cough and difficulty breathing and was told to come to another Hospital, ED; still having SOB, cough, O2 sats 88% on RA; O2 supplementation; pt in respiratory distress; admitted; pt's condition worsened and he passed away in the hospital 2 days later
Got Shingles, received Valacyclovir antibiotics, shingles went away after 3 weeks. Still have occasional nerve pain.
Patient says her arm was red/swollen and painful the day after receiving 2 vaccines in her left arm. Says pain never really went away but has worsened over the last few months. Says she has received acupuncture treatments.
red itchy swollen rash at the site of the vaccination has lasted 3 days. I took benadryl for itching and slight pain
24 hours after receiving the vaccine, began having joint pain. Diagnosed with an inflammatory reaction to the Covid vaccine. Have been doctoring with multiple specialists since. Multiple abnormal lab tests and problems for the last 1.5 years. Joint pain continues.
Fever between 101-102 from Friday evening through today (Sunday), chills, body aches, headaches, tired, diarrhea.
Zoster vaccine given 9-26-07.  Patient states was about 4 inch circle of redness for about 10 days.  Has slowly diminished, today is about 1"x1/2" red.  Not sore to touch, skin is intact.  States she feels a small prick-like feeling a couple of times a day.  It was itching before.  Used Benadryl spray 1x day about 2 wks after shot due to itching.  For about 4 days.  No longer itching, doctor observed the area.