chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingle like blisters and bumps in mouth on upper right side; shingle like blisters; bumps on right arm under injection site; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (shingle like blisters and bumps in mouth on upper right side), VACCINATION SITE INDURATION (bumps on right arm under injection site) and HERPES ZOSTER (shingle like blisters) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030120A-716) for COVID-19 vaccination.     Concomitant products included VALACYCLOVIR [VALACICLOVIR] for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE INDURATION (bumps on right arm under injection site). On 18-Jan-2021, the patient experienced ORAL MUCOSAL BLISTERING (shingle like blisters and bumps in mouth on upper right side) and HERPES ZOSTER (shingle like blisters). On 21-Jan-2021, ORAL MUCOSAL BLISTERING (shingle like blisters and bumps in mouth on upper right side) and HERPES ZOSTER (shingle like blisters) had resolved. At the time of the report, VACCINATION SITE INDURATION (bumps on right arm under injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided  Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Followup received on 08-JUL-2021 & Contains non Significant NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-021980:Crosslinked (MOD21-14971)
This case was reported by a consumer via call center representative and described the occurrence of ulcerative colitis in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 10 days after receiving SHINGRIX, the patient experienced ulcerative colitis (serious criteria GSK medically significant), blood in stool (serious criteria GSK medically significant), mucus stools and diarrhea. On an unknown date, the outcome of the ulcerative colitis was unknown and the outcome of the blood in stool, mucus stools and diarrhea were recovered/resolved. It was unknown if the reporter considered the ulcerative colitis, blood in stool, mucus stools and diarrhea to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to doctor. The patient received the vaccine on left arm. The patient stated that he had a colonoscopy on 9th May 2018 and he was diagnosed with ulcerative colitis. The patient was prescribed medication for the ulcerative colitis and the symptoms had resolved. The patient stated that any follow up could be sent to him and he could forward the information to his physician. The patient did not provide health care professional information during the call. For tolerability of 2nd dose, refer case US2018GSK153596.
A report had been received from a health professional via medical representative concerning a male patient, 12-15 years old. The patient had moderate to severe asthma but wanted FLUMIST Quadrivalent. This child had wheezing and severe asthma attack post FLUMIST Quadrivalent. The patient also had flu-like symptoms within 24-48 hours. Action taken with FLUMIST Quadrivalent and outcome of all the event was unknown. The report was considered to be non-serious by the reporter.
Pain since day of administration.  L arm assessment 2 weeks after administration: tender to palpate deltoid, lateral head of the triceps, and upper trapezoid. Roundish 1 inch area, 1inch below the acromiom process was tender and erythematous. ROM reduced, extension 10 degrees, forward flexion 45 degrees, abduction 45 degrees.
I was tired and I had chills. I had heart compaction after an hour after the shot. These symptoms lasted for about an hour and a half.  I was still at my doctor office when this happened.  So, they monitored my heart rate.
As per vaccine recipient: Became itchy during night of 04/07/2022.  Woke up with hives.     04/08/2022: Consulted with cardiologist as had previous appointment.  Prescribed steroid.  Upon returned home, took steroid.  Vomiting and diarrhea immediately after taking. Approx. 30 mins following, fainted and hit head.  Called 911 and taken to hospital.  CXR, Ct Scan.  Given IV steroid.  04/10/2022: Released from hospital.  Continuing on steroid.
Patient called the pharmacy and stated that he felt very sick and had since he received the high dose flu vaccine (FLUZONE HD). He had been feeling sick for about five days and stated he had been running a high fever. He asked that I report it. It is important to note the patient took a course of amoxicillin for ten days starting 11/9/16 for an unknown ailment.
PRIOR to receiving the 2nd covid-19 Pfizer vaccine had a bowel movement each day after each meal- 3x/day everyday.  03/17/21- The day after the vaccine, bowel movements stopped completely. Became bloated with severe abdominal pain, shortness of breath and difficulty walking due to pain. Tried OTC stool softeners, miralax, prune juice and no relief. Seen in ER on 03/20/21 for abdominal pain, bloating and constipation. CT scans did not provide answers. Seen by GI specialist and had colonoscopy and EGD on 03/29/21 which did not provide answers on sudden stop of bowel movement. Almost a month later still not having bowel movements regularly despite taking Linzess as prescribed, still have abdominal pain and bloating daily, difficulty eating due to bloating and pain, have lost 7 pounds in the past 3 weeks and now remaining in bed more throughout the day due to pain/bloating. Becoming depressed and irritable which was NEVER a problem prior to the 2nd Pfizer covid-19 vaccine.
My gums turned purple for 3 days starting on February 25th.  I also developed canker sores.  It ended up going away
Swelling and pain in right underarm lymph node, started one day after injection and has continued you today, day 2 after injection
I had severe headaches, so bad that I vomited, I had body ache, my feet hurt a lot, dizziness, lose focus (10 minutes), memory loss, I can't work anymore. I called my doctor and he immediately he sent me for MRI, and I will have it on 10/28/2022 to see if there is any change in my tumor.  If there is a change, he will refer me to a clinic but have not have any problem with the tumor since I was 10 years old and I had a check also when I was 19. No problems back then, just now again.
I95.9 HYPOTENSION 9/2/2022 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC I95.9 HYPOTENSION 9/2/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 9/2/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA
NO MAJOR REACTIONS; 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, and batch number were not reported, expiry: 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 no major reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of no major reactions was not reported. This report was non-serious. This case, involving the same patient is linked to 20211261244.
Numbness and tingles on fingers and feet.  At first more pronounced on left arm and feet. Now about the same on both sides.
17-20 minutes numbness in tongue continue to 8:40pm. In addition heavy head and weird sensation in mouth and left side of head.
burning sensation on skin, primarily on arms and back, but also on neck, cheeks and backs of hands general prickly, itchy  sensation  symptoms  were intermittent initially and stronger, particularly at night- then became more persistent and lower level
Redness and hardness on injection site, Nausea, Tiredness & fatigue, Runny nose
pt stated she had an ongoing rash from first covid vax and noticed the rash was spreading after receiving the second dose.  Pt also had fatigue.  Pt saw her PCP after 2nd dose and ordered lab work.  She has a FU appt on 1/29/2021 for regular physical.
2 weeks or so after the second dose I had a very light 5 or so days of menstrual bleeding in the middle of my cycle. My cycles are between 35 and 40 days, so this was strange. I had the copper IUD put in in December so my body is still adjusting and I have very heavy periods.  I have recently started my normal period afterward. The only change otherwise was receiving the 2nd dose of Pfizer.
Tender (L) axillary lymph nodes and edema (L) deltoid muscle.
This spontaneous report as received from a certified medical assistant (CMA) and a nurse refers to a 4 years old patient of unknown age (gender unknown). On 27-MAY-2014, the patient was vaccinated with (Oka/Merck) VARIVAX lot # J0009990; expiration date 13-AUG-2015 (also reported as 12-AUG-2015), which was improperly exposed to 10F for 3 days and to 5-9.6F for 360 hours (also reported as exposed to 16F for 120 hours), subcutaneously. No known adverse effects. This is one of several reports from the same source. Additional information has been requested.
Headache, Myalgia, Fever & NauseaVomiting  Narrative:
inadvertently given two doses / 20 days apart.  First dose / administered on 28Jul2020 / second dose / administered 14Aug2020; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 81-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix).   On 14th August 2020, the patient received Boostrix. On 14th August 2020, unknown after receiving Boostrix and 17 days after receiving Boostrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received boostrix 20 days apart after earlier dose,which led to shortening of the schedule. The reporter did not locate lot and expiration date for the dose administered on 14Aug2020 The reporter was not aware of the patient experiencing any ill effects after dosing. The reporter consented to follow up.
mild injection site soreness, headache, lower extremities aches, chills, reduced appetite for next 24 hours.
pt recv vax & immed exp excessive sting while vaccine was injected w/pain @ site;no tx given;
Hit quickly and strongly. Dizziness, nausea, waves of hot and cold, with profuse sweating. This was followed a couple of hours later by body aches, alternate hot and cold spells and headache. Injection site was sore, which started the previous day. Massive headaches from 4/9 to 4/11. NSAIDs somewhat helped symptoms. Began feeling human on 4/12. Was like a bad influenza, but no one else in household had any symptoms subsequently, so assume it was the vaccination.
Moderate arm pain day 2, lymphadenopathy L armpit Day 3-7, localized L upper arm erythema and itchy rash Day 5- present
Nausea, light headed, dizziness, severe pain at injection site, fever 102.
Pt received his Covid vaccine and as was scheduling his second dose, pt stated he started to feel dizzy. patient was reclined and gavin juice and called for assistance from the LVN . Pt was pale, clammy/sweaty, and dry heaving.; call for Rapid Response. They were in the pt's room within the minute and proceeded to take vitals and treated the pt with a bag of IV fluid while having the pt be observed by an RN for an additional amount of time. After the nurse observed the pt walking on his own, she gave pt permission to leave. Patient was discharged 1601 after receiving a liter of NS IV.
This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On 01-OCT-2014 the patient received first dose of GARDASIL 0.5 ml (lot # and expiration date not reported), intramuscular. On 21-OCT-2014 patient received second dose of GARDASIL. No concomitant therapy was reported. No adverse effect was reported. No product quality complaint (PQC) was reported. Outcome of the events were not reported. Causality assessment was reported as not related to therapy with GARDASIL. Additional information has been requested.
24 hr post vaccination parent reported visible redness, to bilateral thighs. Parent reported warm to the touch and painful.  Pain lasted q 24hr and reduce to only tender feeling 48hr post injection.  Right leg  redness present from below injection site on anterior lateral thigh extending almost to the hip and down to the knee cap. Left leg redness occurred below the  knee extending towards her ankle
Information has been received from a 62 year old female consumer with a history of seasonal allergies who on 22-JAN-2008 was vaccinated with .65ml ZOSTAVAX (Oka/Merck). Concomitant therapy included "vipalopran" for blood pressure. On 23-JAN-2008 the patient developed a rash on her stomach. Unspecified medical attention was sought. There was no lab studies performed. Subsequently, the patient stated she recovered "about a week or two afterwards." Additional information has been requested.
patient reports itching on scalp, moved down to upper face and ears, tongue felt numb, puffiness around eyes, then reported chest itching.  Epi Pen and Benadryl given.
The week he was due to get the second shot he had Petechiae on his stomach, legs and neck. He then presented large (nickel size) blood blister (about 10) inside his mouth. Whenever he popped them they would immediately fill back up. The night before his second shot he was urinating blood (urine was the color of cranberry juice). We went to the ER and they said he has 2 platelets. He had to get multiple platelet transfusions and was admitted for a few days. From there he needed to stay on prednisone for a month or more and see a hematologist weekly.
Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA638A, expiry date 30th November 2022) for prophylaxis.   On 7th December 2022, the patient received the 1st dose of Menveo. On 7th December 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: Medical Assistant called in to report that on 7th December 2022, a patient was inadvertently administered an expired dose of Menveo.  Patient's information for adverse event was disclosed and medical information about the maladministration of Menveo after the expiration date was given.  They requested the information be sent to their email account. The reporter consented to follow up.  The Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient received vaccine, which was already expired on 30th  November 2022, which led to expired vaccine administered.
pt recv vax 29FEB96 & 20MAR96 pt devel a gen rash on stomach, back, inner thighs, & face;rash was described as very many reddish pin pricks, little red dots on 20MAR96;21MAR96 the rash was bumped up;there were over 60 lesions on stomach;
Eye Problems started with left eye - colored flashing light lasted 15 minutes on March 15th. No accompanying symptoms - eye was then sore.  Went to Eye Doctor on March 16 Had another episode in the right eye and a third episode in the right eye - black and white chevron pattern  Having intermittent issues since - April 15th
medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; administered to patients after temperature excursion with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 46 years old and unknown gender patient and reporter reported temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event and was administered to patients after tempearature excursion with no reported adverse event while receiving vaccine influenza quadrival a-b vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Sep-2022, the patient received a dose of suspect influenza quadrival a-b vaccine (lot UJ899AA) Suspension for injection (with an unknown strength, dose, frequency, route, expiry date, administration site) for immunization.   On an unknown date the temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event (Product storage error) (latency unknown) and On 22-SEP-2022 the patient was administered with the vaccine influenza quadrival a-b vaccine with no reported adverse event (poor quality product administered) (latency same day).  No lab data reported.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for both the events.  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 the 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.
c/o soreness & bruised p/inj; used warm compresses; 26APR redness & edema occurred; c/o itching @ site; area 3x3inches of redness w/warmth on lt arm 27APR:
Patient came in 10/27/2023 in the morning to report the side effects. She said she went to the hospital down the street on Saturday 10/21/23 and got admitted and didn't leave until yesterday 10/26/23. According to patient after many tests they came in conclusion that she had 3rd cranial nerve palsy due to the covid vaccine she got 10/20/23. Patient showed her left eye lid was not able to open at all. She used her fingers to lift her eyelid she said she can see a blurry vision of two people in front of her.
SHINGRIX mixed with sterile diluent instead of recommended diluent and administered to patient. Patient had no adverse reactions at time of administration or after before leaving clinic. Clinic has not heard from patient since.
I had a very sore, lumpy arm for 1st 4 days  after injection but over a week later, the site got very itchy and rashy that seemed to spread when I scratched it. It is tender, hard and extremely itchy. Read this is called Covid Arm and can be a side effect with Moderna vaccine.
Might have got the Flu one year but if it was it was a mild case; Initial information received on 05-Oct-2021 regarding an unsolicited valid Social media non-serious case received from a Consumer.  This case involves an adult patient (unknown age and gender) who experienced might have got the Flu one year but if it was it was a mild case (Influenza) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient might have got the Flu one year but if it was it was a mild case (Influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got mine. Get it every year. Might have got the Flu one year but if it was it was a mild case".  It is unknown if the patient experienced any additional symptoms/events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Sudden onset tinnitus (never had tinnitus before) within one day of vaccination, accompanied by intermittent inner ear pain. Following an audiogram and doctor's exam, doctor determined that cause of tinnitus and inner ear pain is unknown. Tinnitus and ear pain continue, without treatment, increasing in severity, leading to loss of sleep, inability to focus at work, unable to hear some sounds, severe distress.
Ringing in my left ear began the week following the first Moderna Covid vaccination this continues at present. I have experienced some loss of hearing in my left ear as well.
Injection site was red; Injection site was swollen; injection site had a large welt; swollen; Red; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (swollen), ERYTHEMA (Red), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE URTICARIA (injection site had a large welt) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy, Pollen allergy and Allergy to animal.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced SWELLING (swollen) and ERYTHEMA (Red). On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE URTICARIA (injection site had a large welt). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (swollen) and ERYTHEMA (Red) outcome was unknown and VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE URTICARIA (injection site had a large welt) was resolving.        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.
This is a spontaneous report from contactable physician via Pfizer Sales Representative. A patient of unspecified age and gender received TRUMENBA (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for prevention of meningococcal meningitis. The patient's medical history and concomitant medications were not reported. The patient had redness, swelling and pain at injection site on an unspecified date in 2019 for two weeks. The outcome of the events was unknown. Information on lot number, batch number and expiration date has been requested.
Shortly after vaccination, entire arm was very sore.  Soreness ended, however the arm is very sensative to any pressure and has been for 3+ days.  If you roll on it sleeping, it will wake you up.
Pt received 3 doses of Recombivax & 1 dose of Engerix B was found to be a nonresponder.