chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Just finished quarantine for covid (14 days); Moderate cold symptoms; Tiredness; Coughing; Just finished quarantine for covid (14 days); This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced covid-19, cold symptoms, tiredness, cough and quarantine. On an unknown date, the outcome of the covid-19 and quarantine were unknown and the outcome of the cold symptoms was recovering/resolving and the outcome of the tiredness and cough were not recovered/not resolved.   It was unknown if the reporter considered the covid-19, cold symptoms, tiredness and cough to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's comment: This case was reported by patient. The patient just finished quarantine for Covid (14 days) and had moderate cold symptoms and was better and still had some tiredness and coughing. The patient was scheduled for second dose of Shingrix in 2 days. The patient asked should he/she postpone Shingirx booster dose. The patient asked would receiving GlaxoSmithKline vaccine lower a patient's immune system and make them more susceptible to COVID-19. The patient was not felt comfortable for giving his/her personal information. He/she just wanted to know if the effectiveness of the vaccine would be compromised. Additional Supportive Information: The follow-up would not possible as no contact details were available.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Influenza vaccine with an associated reaction of pain in extremity (refer case US2018GSK110165.). On 22nd May 2018 14:30, the patient received the 1st dose of SHINGRIX (intramuscular) 1 ml. On 22nd May 2018, 30 min after receiving SHINGRIX, the patient experienced pain in arm. On 25th May 2018, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be possibly related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medications included cholesterol medicine and blood pressure medicine. The soreness was constant but it resolved after 2 to 3 days. The soreness was a little more intense than what he experiences from a flu shot. The patient did not take any medicine for treatment.
Pfizer vaccine was diluted with NS 0.9% Bacteriostatic which is not recommended for use with this vaccines. Reported to Pfizer and CDC. As per recommendation from CDC, affected dose should be repeated. Attempted to notify pt of the need to repeat the vaccine.
Has 6 X 8 cm, red, indurated area left upper arm. The pain slightly itchy.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-JAN-2015, the patient was received improperly stored VARIVAX (lot # K005427, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
This spontaneous case reported by a pharmacist, describes the occurrence of accidental underdose (immunocompromised patient received a 0.25mL dose as the third dose) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included immunocompromised status. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 0.25 milliliter. On an unknown date, patient experienced accidental underdose (immunocompromised patient received a 0.25mL dose as the third dose). At the time of the report, accidental underdose (immunocompromised patient received a 0.25mL dose as the third dose) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
The next day after taking the vaccine I was sore. I don?t mean like boo hoo this is annoying. It was hard to do anything. Moving my toes was pain level 4. Walking was pain level 7. Everything that bends hurt. My brother said my joints were warm to the touch.
Child is 5 years 3 ;months and had modern as primary series. Presented with parent and requested Moderna Bivalent.  Child was given 0.25ml of Moderna Bivalent. Father contact 11/3/2022 and 48 hours post vaccination child has no side affects from vaccine at this time. Child Pediatrician informed as well
My heartrate went up to 168 bpm resting and it lasted for about 20 minutes staying within the range of 145-168 (Since I work for a hospital/medical facility they were monitoring me the whole time).  The EMS picked me up after 30 from the beginning of the event.  I got to the hospital emergency room within 10 minutes.  By the time I reach the hospital my heartrate was documented at around 98.  They did all type of test and everything except for the EKG came back abnormal.   I had a few episodes of palpitation within 1 weeks of the vaccine including a few hours after the 1st dose.  I monitor my heartrate at the time and it was at about 125 resting but it went back down to the 90s within a few minutes so I didn't think anything of it.  The same happened a few times within the first week of the vaccine except on the 4th day it went up to 168 and didn't go back down within a few minutes.  I was discharged from the hospital the same day and told to follow up with a cardiologist which I did and was told everything was ok with my heart.
suspected vaccination failure/I still get shingles and have had them 3 times since; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received 1st and 2nd dose last year and still experience Shingles and had 3 times since then. It was a milder case, but he/she was hoping they would be over and done with it. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
About 9 am the day after the vaccine I noticed some joint soreness. By 3 o clock PM that day I had to leave work early because of intense joint pain. I came home and had a fever, diarrhea, joint pain, a headache and bone pain. My tibia, fibula, sacrum, ileum, and ishium were on fire. I decided to take some over the counter anti inflammatory medication and some benadry. I slept one hour at a time all night due to excessive sweating and pain, but felt significantly better the next day.
Mom reports rash appeared around injection site about 24 hrs post vaccine. 3 cm x 4 cm patch with scattered red papules approximately 2 mm & excoriations observed on 11/5/12 on exam by Dr.
body aches, fever, abdominal pain, headache everything still occuring except body aches
A few days after the vaccine again I woke up with the same excruciating back pain but I realized it was not back pain but more kidney pain.  I used the Salon Pas again which made symptoms get a little worse but within the next few days the pain went away.  And was back to normal again.  In Sept on labor day weekend I went to bed and got up later to urinate but couldn't.  I let a couple days past without urination and after I still couldn't urinate I went to the Hospital ER where a catheter was inserted.  Advised to see a Urologist.  At that appointment a week later the catheter was removed , but because I still could not urinate so another was inserted.  A Cystoscope was done and the bladder was fine.  My prostate was enlarged prior to the vaccine but after the vaccine it got really big resulting in me now having an appointment where part of my prostate is now scheduled to be removed.
extreme bronchospasm/asthmatic attack;edema of airways,dyspnea,extreme inflammation & edema documented by bronchoscope still cont 6mos later;bronchiectasis caused by antigens in vax close to severe pneumonia/immunogenic rxn
This spontaneous report as received from a nurse refers to a 47 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 16-JUL-2014 the patient was vaccinated with expired PNEUMOVAX23 (lot# H017759, expiration date: 04-JUL-2014). Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was reported for PNEUMOVAX23.  Additional information is not expected because the reporter does not want to be contacted regarding the report.
Large red itchy lump swollen pain on a large area of the arm but outside the band aid area-still occurring adv that this type of delayed rash has been seen with <1% of patients with this shot, also could be caused by or exacerbated by the bandaid due to latex allergy. Either way, try OTC DPH, topical hydrocortonse, warm compress, or cold compress/ 10 min ice at a time (whatever helps relieve symptoms, should start resolving after a few days. Seek emergency medical attention if trouble breathing/swelling in airway but reassured caller based on time of the injection this would be highly unlikely. PCC will FU later, provided
pt recv vax; lt thigh warm to touch & firm area noted size of 1/2 $; T 101 on 21jun95; no redness at site;
Multiple Er visuals, 9 day hospitalization, slept (pretty much comatose) for 4 days, persistent cough, problems breathing, vomiting, body aches from head to toes, tired, exhausted, weakness (legs feel like noodles), loss of appetite, can?t get enough sleep, dry mputh, excessive thirst, cough & problems breathing continues months later as well as exhaustion and weakness , dehydration,
Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 10 years old patient who was vaccinated with a dose of DAPTACEL (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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. Documents held by the sender: None.
Pt received the wrong vaccine.  First 2 doses of the primary series was Moderna.  3rd dose received was Pfizer bivalent.  No treatment needed.
on 1/29/21  states had 2nd covid vaccine on 1/26/21- felt faint after the clinic, on 1/28/21 didn't want to eat or drink, hrt rate 110, BP nl, laid down to rest, Hrt rate  was 80-100, had EKG which was nl with pulse 90, went hone and rested, noted going up stairs pulse would inc to 130, felt dizzy, pulse would then go down to 80's after, has now been eating and hydrating; communication 1/30/21-sx resolved
Difficulty Breathing, Wheezing, Red Eyes, Puffy Face, Tiredness
1410 Tetanus shot given shortly thereafter developed symptoms of light headiness, felt faint, pallor, diaphoresis, warmth, loss of consciousness approximately 2 seconds. Thought to be due to prior donation legs elevated. 200 cc juice given full recovery, vital signs normal at 1520.
anosmia; Ageusia; covid-19; Slept most of the day; Extremely Tired; Fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANOSMIA (anosmia), AGEUSIA (Ageusia), COVID-19 (covid-19), SOMNOLENCE (Slept most of the day) and FATIGUE (Extremely Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 31-Mar-2021, the patient experienced SOMNOLENCE (Slept most of the day), FATIGUE (Extremely Tired), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced ANOSMIA (anosmia), AGEUSIA (Ageusia) and COVID-19 (covid-19). On 01-Apr-2021, SOMNOLENCE (Slept most of the day), FATIGUE (Extremely Tired), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, ANOSMIA (anosmia), AGEUSIA (Ageusia) and COVID-19 (covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment med: Tylenol Patient was scheduled for the second dose of the Moderna COVID-19 Vaccine on 28Apr2021. Patient was extremely tired and experienced fever and chills and slept most of the dayThen couple of days later, patient lost sense of smell and taste and went for COVID test. patient tested positive.she started feeling fine.   Reporter did not allow further contact
Expired Engerix B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 46-year-old female patient who received HBV (Engerix B adult) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th October 2022, the patient received Engerix B adult 20 ml and Engerix B Pre-Filled Syringe Device. On 14th October 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-Dec-2022 Reporter's comment: The reporter consented to follow-up. This case is for 2 of 2 linked cases reported by same reporter. Additional supportive information: The patient received an expired dose of Engerix B (20 mcg/ml), which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022191313:Same reporter
11aug88 joint pains recurred intermittently;then dx:rheumatoid arthritis w/RF-1900 &rheumatoid nodules;14oct86 rheumatoid nodule removed from rt 5th metatarsal;ANA-40 /w speckled pattern;16aug93 pt had polyarthritis;
The patient experienced an increase in her blood sugar the following morning after receiving these vaccines. She said it started at about 180 mg/dL and steadily increased to about 300 mg/dL.
Mild pain at place of administration; General mild tiredness.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection), administered in arm left, administration date 16Mar2021 at 10:30 (Lot number: EL3247) at the age of 36 years 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 time: 10:00 AM, vaccine location: Left arm), administration date: 23Feb2021, when the patient was 36 years old, for COVID-19 immunisation, reaction(s): "Mild/moderate pain at the site of injection".  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Mar2021 17:00, outcome "recovering", described as "Mild pain at place of administration"; FATIGUE (non-serious) with onset 16Mar2021 17:00, outcome "recovering", described as "General mild tiredness.". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination. The patient had not been tested for COVID post-vaccination.  No follow-up attempts are possible. No further information is expected.
Fever, full body soreness, lethargy, fatigue, headache, weakness, increased sensitivity
Within 10 minutes of receiving the immunization the patient felt hot, and pain down the back of his head and neck.  He stated his chest felt somewhat heavy off and on.  He did not have labored breathing.  He was given cold compresses, blood pressure was monitored and 50mg  of oral benadryl was given.
Patient said she had a low grade fever for 3 days following vaccination and flu-like symptoms. She had a rash on arm as big as "potato" in her words which was bigger the 4th day when she called pharmacy. Pt was feeling better by 5th day.
Receiver second Pfizer shot on January 20 2021 and that night at 01:30 January 21,2021 I woke up with a rapid heart rate extreme headache and a fever of 102 I had shortness of breath and was taken to hospital. The ER performed a work up and my main complaint was my heart was hurting really bad I felt like my left carotid artery was swollen or  occluded
This spontaneous case was initially received on 05-Oct-2015. The case report was received from a Health Professional and concerns a 23 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 02-Oct-2015, Batch no: U55906, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 02-Oct-2015, after starting treatment with AFLURIA the patient experienced Half of the vaccine coming out of injection site, [Half of the vaccine coming out of injection site] and running down the patient's arm. For relevant test results see appropriate report section. Reporter's assessment: The reporter considered events non serious.
Caller reports patient's MMR II titers were low. Rubella titer  0.98,  measles less than 13.5 and mump less than 9.0.; Caller reports patient's MMR II titers were low. Rubella titer  0.98,  measles less than 13.5 and mump less than 9.0.; Caller reports patient's MMR II titers were low. Rubella titer  0.98,  measles less than 13.5 and mump less than 9.0.; This spontaneous report was received from a nurse referring to a 28 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.         On an unknown date, the patient's titers were low, rubella titer 0.98, measles less than 13.5 and mump less than 9.0 (units not provided). The outcome of the events was unknown. The causality assessment was not reported.
On July 7, 2021 the right leg behind the knee begin to bother the patient. At the end of her day, the entire right leg swelled up. The duration of the adverse effects were for five days. On the fifth day the patient was admitted into the hospital because she couldn't breathe. She was hospitalized for three days. The medical staff discovered the patient had blood clots.
This case was reported by a healthcare professional and described the occurrence of pain in an 18-year-old male subject who was vaccinated with Boostrix for prophylaxis. The subject had no significant medical history or concurrent conditions. Concurrent vaccination received the same day as 2nd dose of Boostrix, 21 August 2006 included Menactra in the right deltoid (lot number and expiration not provided). On an unspecified date in March 2006 the subject received a dose of Boostrix at 0.5 ml. On 21 August 2006 the subject inadvertently received a second dose of Boostrix (lot AC52B005AA) intramuscularly in the left arm. This was considered to be a medication error as the interval between doses of Boostrix was too short. The recommended interval is 10 years. Following the inadvertent administration of the 2nd dose of Boostrix, 21 August 2006, the subject developed achiness and fever. The events resolved on 25 August 2006. The healthcare professional considered the events were possibly related to vaccination with Boostrix.
Immediate pain, swelling of the R upper arm. Redness, warmth persistent for weeks, and on 11/7/2023 on day of exam she continues to have mild redness and soreness at the distal deltoid muscle
Vomiting, paresthesia of hands & feet dizziness pallor. Seen in ER on 01/27/10 @ 10:30 pm, treated and released.
On 8/31/2021 at about 12.05p.m. patient received her 1st dose of Pfizer covid-19 vaccine at our pharmacy. Immediately after getting the injection she started complaining of feeling hot, nauseated and dizzy. She sat down and requested for some cold water. She was given a bottle of water which she drank some and dabbed some on her forehead. she remained conscious all the while and refused to have an ambulance called for her. She stated that she has a history of feeling this way whenever a needle is used on her even when drawing blood. Her husband and son were with her and they both collaborated her statement. Both men had received their Pfizer vaccines from the same vial a few minutes before her. I checked patients BP and pulse and they were all normal(BP 119/78, P62).We monitored her for 30 minutes after which she walked out of the pharmacy on her own.
I had "Covid Arm" and I put ice on my arm to reduce the redness, itching and swelling.
PT RECEIVED MODERNA FOR 1ST DOSE AND PFIZER FOR SECOND DOSE. NOT REACTION.
Red raised rash to chest, trunk, buttocks, and upper arms. 9/25/11 Rash developed later that day. Went to ER & Dr gave her BENADRYL. Required visit to NP & received steroid Rx. Red, itchy rash to chest, trunk, buttocks & upper arms. Few spots to lower inner arms.
Arm pain with warm, red, sl raised c/w large hive at visit covers 10x20cm area.