chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15-20min itchy eyes;30-45min oral edema;24hr p/vax inj site skin rxn 7.5 x 4cm will check w/allergist re: next flu shot & whether to get it;
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 64 years and 10 months old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot no UJ010AC and expiration date 22-APR-2019) via unknown route in the left arm on 18-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due product storage error and vaccine was administered to patient of inappropriate age (it was reported that temp excursions of High dose Flu vaccine occurred and administered to a male patient who was 64 years and 10 months old) without any adverse effects noted. 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 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. List of documents held by sender: none.
A pharmacy technician administered the correct Pediatric Pfizer Bivalent COVID vaccine to the patient (5 yo) but forgot to dilute the vaccine as indicated. Technician didn't showed Pharmacist the dose before being administered to the patient and administered the vaccine without the vaccine being diluted. When the event was known close to 10 pm, the Pharmacist called the patient's mother at 10 pm regarding the patient's condition after vaccine administration. The patient's mother stated that the patient was doing well and didn't had any fever or pain related to the vaccine administration.
Fatigue; Diarrhea; Feeling Unwell; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and MALAISE (Feeling Unwell) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Blood Pressure Medication, PROPRANOLOL and Diuretic Pills for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and MALAISE (Feeling Unwell). At the time of the report, FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and MALAISE (Feeling Unwell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous case was reported by a consumer, describes the occurrence of dizziness (dizzy after second shot) and asthenia (can't do anything after second shot) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 10, 2021, patient experienced dizziness (dizzy after second shot) and asthenia (can't do anything after second shot). At the time of the report, dizziness (dizzy after second shot) and asthenia (can't do anything after second shot) outcome: unknown. No concomitant medication or treatment information provided.
Dry mouth; Dry lips; Dry feet; gain weight; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), LIP DRY (Dry lips), DRY SKIN (Dry feet) and WEIGHT INCREASED (gain weight) 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 an unknown date, the patient experienced DRY MOUTH (Dry mouth), LIP DRY (Dry lips), DRY SKIN (Dry feet) and WEIGHT INCREASED (gain weight). At the time of the report, DRY MOUTH (Dry mouth), LIP DRY (Dry lips), DRY SKIN (Dry feet) and WEIGHT INCREASED (gain weight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
myocarditis developed 2 days after the 2nd shot.  troponin almost 22K.
is now experiencing fever and a runny nose; is now experiencing fever and a runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer.), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), RHINORRHOEA (non-serious) all with onset 2022, outcome "unknown" and all described as "is now experiencing fever and a runny nose".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt came to ER c/o sinus pressure, headache, cough, diarrhea, fever.
Patient started complaining of some chest tightness about 30 minutes after getting vaccine, O2 in low 90s. We administered O2 at 2L and gave a nebulizer treatment under the CNP onsite. She iniatially improved, but then started wheezing and BP started dropping, then gave epi and started fluids. Patient started allergy shot immunotherapy between first and second doses COVID; last dose 24 h prior to second covid vaccine.
Injection site became hot, raised like a welt and splotchy.  The area covered the backside of my arm. The red raised area became sore like a burn and itchy. Any type of contact with the site is painful even soft cloth covering my arm irritates the area. Periodic stabbing prickly pain in the injection site. Any pressure contact such as leaning against car seat or sofa results brings great discomfort.
"Immediately, it was quite painful with sharp stinging. Discomfort became worse about 2 days following vaccination and persists one week later. It is not severe - but persistent and limiting my activities it even hurts to lift my arm to drive. My entire deltoid is sore to palpation, especially the medial and outer deltoid area and it hurts to abduct my arm on 11/14/17". (L) arm is still a little sore for about 8 to 10 cm directly over flu shot site if I palpate it.
Administered the booster dose  (0.25ml) instead of the 3rd dose; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Patient has underlying malignant condition).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED. At the time of the report, INCORRECT DOSE ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  Physician states that they had administered the Moderna Covid-19 booster dose (0.25ml) to a patient who was supposed to receive the 3rd dose.
My first menstrual cycle after the second shot was extremely abnormal. It came early.  On the third day I had very intense cramping and felt like I was hemorrhaging. It stopped after a few hours. The next day it was all over. Usually my cycle lasts 5-7 days. I have not had another cycle yet since this one.
At site of DtaP injection, large area of warmth and erythema, nontender, admits itching. Mother had given no medications for. The previous day she applied cold compress.
fever/Fever of 101.5; headache so bad I couldn't move or even sit-up; headache so bad I couldn't move or even sit-up; aches; chills; I'm currently still ill at 84 hours.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 66-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6204), via an unspecified route of administration (at the age of 66-years), administered in arm left on 12Mar2021 at 10:30 as dose 2, single for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included lisinopril (LISINOPRIL), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN9581), via an unspecified route of administration (at the age of 66-years), administered in arm left on 19Feb2021 at 00:30 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and it was unknown that the patient had been tested for covid post vaccination. The patient had no known allergies. The facility type vaccine was reported as other. The facility type vaccine other was reported as senior center. On an unspecified date in Mar2021, the patient experienced fever/fever of 101.5, headache so bad i couldn't move or even sit-up, aches, chills, I am currently still ill at 84 hours. It was further reported that 30 hours after the 2nd shot I developed a fever, chills, aches. Improved by 48 hours. Then it hit the fan at 54 hours. Fever of 101.5, headache so bad I could not move or even sit-up, aches and chills. This has continued for over a day. I am currently still ill at 84 hours. The treatment was not received for all the adverse events. The patient underwent lab tests and procedures which included body temperature: 101.5 on an unspecified date Fever of 101.5. The clinical outcome for all the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Upon administering the vaccine the needle came off the barrel of luer-lok syringe. Most of the dose spilled over patient's arm and inject-safe barrier bandage. Pharmacist was confident that less than 1/2 the dosage was administered. The vaccine was administered again to ensure patient received adequate dose.  Pharmacist followed up with patient. Made several attempts to contact patient. Patient responded 6/17/21. She is feeling fine. She experienced slight fever the day of  vaccine. Symptom is typical of Moderna vaccine.  No hospitalization was required.
(L) upper arm redness, hot to touch, edema to injection site, required 2 grams of ROCEPHIN IM and then KEFLEX 500mg PO BID x 10days.
Injection site rash, severe pain at injection site, severe body pain, generalized muscle pain and weakness, generalized inflammation response, fever 101+, sleeplessness, irritability, began day after injection for a duration 4 or more days, treated with Vicodin, bed rest, Tylenol; diarrhea, headache, migraine, generalized inflammation and pain, generalized hypersensitivity (food, chemical, allergens), continues after 3 weeks post injection with some improvement.
Nausea and headache started last night. + emesis 3-4x  + chills, rapid pulse, fever to 101 + deltoid pain + muscle soreness
Nurse drew up a covid 19 vaccine for pt but the vial used was punctured greater than 12 hours prior to administration.  Pt was contacted, and informed pt's caregiver, reported only being more fatigued than normal for a couple of days, no other side effects. Provider informed.
Tingling in the ears; Nervous problem in ears; sensation in ears; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the ears), EAR DISCOMFORT (Nervous problem in ears) and EAR DISCOMFORT (sensation in ears) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PARAESTHESIA (Tingling in the ears), EAR DISCOMFORT (Nervous problem in ears) and EAR DISCOMFORT (sensation in ears). At the time of the report, PARAESTHESIA (Tingling in the ears), EAR DISCOMFORT (Nervous problem in ears) and EAR DISCOMFORT (sensation in ears) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.     This case was linked to MOD-2021-106930 (Patient Link).
mom called 2 hr p/vax pt pale, clammy, limp, unconscious for a few seconds took to ER;pt fine taken to ped;pt fine to recv DTAP from now on per nurse;e
Small papular rash on upper chest, deltoid, back, and neck; This case was reported by a nurse via call center representative and described the occurrence of papular rash in a 35-year-old female patient who received HBV (Engerix B) (batch number 2224M, expiry date 1st March 2022) for prophylaxis.   On 16th September 2019, the patient received the 2nd dose of Engerix B. On 17th September 2019, 1 days after receiving Engerix B, the patient experienced papular rash. On an unknown date, the outcome of the papular rash was unknown.   It was unknown if the reporter considered the papular rash to be related to Engerix B.  Additional details were provided as follows: The reporter stated that, the patient developed small papular rash on upper chest, deltoid, back, and neck the next day after receiving vaccine. No itching, fever, or malaise. The reporter consented to follow up.
No text provided. Doc 204225 received on 11/27/2001 states the following: No speech, sleeplessness, poor eye contact, poor diet, sensory modulation deficits, fine motor delay, tactile sensitivities, constipation, must be assisted with all self care areas, anxiety. The majority of symptoms were immediately following the vaccinations.
maculopapular rash cheeks > small amount trunk & chest & legs;mild upper eyelid edema;cervical node rt;
Patient developed large area of redness around what appears to be the injection location of either the MMR or the Hep A injections.  Reaction is on the left otter/posterior leg above the knee.  Although documented that 1 vaccine was on the left thigh and one on the right.  Both injections sites appear to be on the left outer leg based on this reaction and another location of what appears to be a needle stick and bruise.  This is a situation of an improperly placed injection and a localized site reaction.
Received 1st dose 1.8.21 and second dose 2.3.21.  Week of  April 19 began feeling bad, increasingly SOB.  Severe SOB 4/22 that subsided.  Admitted to hospital 4/25 with severe SOB.   Diagnosis muliple Pulmonary Emboii.  No cause identified.  Labs/genetic studies negative.  Treated with heparin and on Eliquis now for life.
02-20-2021 Heart Attack. 100% blockage of LAD artery, Stent, 4 day hospitalization at Medical Center. Recovered heart function. Cadiac rehab.
Patient contracted Covid and was hospitalized 10 days after 1st vaccine and stayed in hospital for 7 days. Symptoms included fever, nausea, dizziness, and shortness of breath.
pt recv vax 25JUN96 & devel large area of redness on 27JUN96;instructed to put warm compresses on arm;28JUN96 saw MD red welt 5" wide 3" deep, can barely raise lt arm;advised to go to ER;1JUL96 lymph nodes swollen lt arm;knot @ inj site;
Pt receved Moderna second dose on 07/16/2021 at 9:30 AM. Three days later on 7/19/21 at approximately 11 am, she began experiencing chest pains. "My hear began to hurt. If felt as if it was being squeezed. I felt pin needled poking in my hear. My left arm went cold and numb. I couldn't breath." She ended up  in the emergency room believing she was having a heart attack. She has never experienced any heart related events before this.  It is important to note that she has no underlining health issues. Her only health issue is migraines which she takes a migraine (some triptan for, possibly sumatriptan...she does not get her meds from my pharmacy). She was released from the hospital after less than a day stay. Tests were performed which shows she did not have a heart attack. She is to follow up with a cardiologist on 8/2/2021 to see if the issue is resolved or there is any lasting affect to her heart. Since her release from the hospital at the onset of symtoms, she only began to feel better and be able to walk and talk approximately 3 days ago. She came into the pharmacy today to tell me of these events. She appeared well, however, she does say that she still feels SOB, pin needles poking at her heart, dehydrated, and problems breathing about once every hours. She drinks about 5 bottles of water now, when before she only drinks about 1. I told her to update me once she sees the cardiologist on 8/2/21.
Patient stated she became dizzy the night after shot and it lasted x 2 days. She states her arm was red and itchy. She received shot 3-6-08, she called and reported 3-10-08
Client presents to clinic following immigration physical with order for TD MMR vaccinations. After vaccines administered client requests weight check to see how much weight she had gained during her pregnancy. Did not report pregnancy prior to this because "the doctor who did my physical didn't say it would be a problem and they knew I was pregnant. No diagnosis listed.
Patient was talking and laughiong throughout administration. Told parent that she needed to wait 15-20 mins after vaccines to make sure she feels OK. About 5 mins after vaccines given, patient was being moved to an outside hall bench (within the practice) she took a few steps and stated her eyes felt "funny" and she became pale and slightly sweaty. Moved to a lying position with feet elevated above heart. Given water. Patient felt "back to normal" about 10 mins later. Kept an additional 15 mins for observation.
I've had serious reactions to flu vaccines and the stated that I should wait 30 minutes after taking the covid vaccine to see if any adverse effects would occur. Nothing happened. Early Saturday morning, three days after the first vaccine shot, I awoke with heavy itchy and burning sensation on both ankles, which I then noticed that I had broken out in a rash on my arms. I took Benadryl and then used some crème that I had from shingles and it helped by numbing the area. After calling the Dr. three days later, she prescribed Clobetasol cream for the affected areas.
This was my second shot in the series.  I also had a bad reaction for the first, but not as bad as the second.  When I woke on the morning of 7/7/2019 I was not feeling well.  As the morning progressed I did not feel any better and finally took my temperature.  I had a fever of that vacillated between 100.1 and 100.9 through the day.  I also had lower abdominal pain, nausea, and a bad headache- migraine like.  Fever finally broke around 8:00 PM, but headache, abdominal pain and nausea remained.  When I woke on 7/8/2019 abdominal pain, and nausea were gone, but I still had a headache that remained until about midday.
This case was reported by a other health professional via call center representative and described the occurrence of nausea in a female patient who received FLUARIX QUADRIVALENT (batch number ZG3S5, expiry date 30th June 2017). On 8th October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced nausea, vomiting and hypotension. On an unknown date, the outcome of the nausea, vomiting and hypotension were unknown. It was unknown if the reporter considered the nausea, vomiting and hypotension to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously not reported to anyone. The age at vaccination was not reported for this report. The case was previously not reported. The other health professional stated that she would call back with details regarding the other two adverse events. This case has been linked with case US2016GSK149944 and US2016GSK149943 as reported by same reporter.
Hives over most of body. Extremely itchy. Started on day 15 after vaccine. Went to urgent care on day 16. Put on Hydroxyzine, famotidine, clotrimazole/betamethasone topical ointment. Day 17 woke up and am 75% better on itchiness. Welts are still there but puffiness is mostly gone.
The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 14Feb2019, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician received via a sales representative. The physician reported similar event for 2 patients. This is the 1st of 2 reports. An 18-year-old male patient received TRUMENBA, lot number and expiration date was not provided, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced flu like symptoms, fever 102 x 2 days, large area red and sore at site for both doses. The outcome of the events was unknown. Information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2019080961 Same reporter/product, similar event, different patient.
got the shots. / got the shingles again / had the 2 shots/ Suspected Vaccination failure; shingles; painful; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient got the shots last year. The patient had the Shingles twice. The patient had Shingles again and this time it was very painful. So the reporter asked did the shots not work, they did not work for him/her.  The patient got 2 shingles shots and he or she got the Shingles again just this week from date of reporting. The patient said unreal. This case was considered as suspected vaccination failure as details regarding, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
elevated temp of 105 406 hr p/vax;relieved w/APAP;