chrisvoncsefalvay/vaers-outcomes huggingface dataset:
excursion was due to the door being ajar. The temperature of the refrigerator reached 41.0-62.0 degrees Fahrenheit with no adverse event; Initial information received on 03-Jan-2023 regarding an unsolicited valid serious case received from a other health professional.  This case involves an event of product storage error of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (excursion was due to the door being ajar. the temperature of the refrigerator reached 41.0-62.0 degrees fahrenheit with no adverse event).   On 30-Dec-2022, it was reported DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ680ABA), DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U7561AA) and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot (U7576AD) (strength, formulation, dose, route and expiry date: unknown) to be used for immunization was exposed to excursion due to the door being ajar. the temperature of the refrigerator reached 41.0-62.0 degrees fahrenheit with no adverse event (product storage error) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown.   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 guidelines. 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.
Patient at clinic for well child physical, vaccines given before knowledge of pulmonary stenosis patient stayed in clinic approximately 2 hours after vaccines administered, no adverse reaction during visit agency and caretaker reported neg. medical history.
Patient history of mechanical aortic valve and mitral valve and is on chronic anticoagulation with Coumadin with therapeutic INR of 2.6 today on arrival, presented with chest pain and EKG showed ST elevation she went for emergent cath coronary cardiac catheterization that showed bowel significant lesion in the LAD status post stenting now. Anterolateral ST elevation myocardial infarction, attempted access via right groin, 99% right common iliac stenosis seen with iatrogenic wire induced dissection up to the distal aorta involving the right common iliac.  At the conclusion of the case a limited distal aortic runoff was performed with a pigtail catheter via the right radial artery which revealed distal abdominal aortic aneurysm which is mild with severe left common iliac stenosis, severe right common iliac stenosis with what appears to be collateral beds in the distal aorta that go to the lower extremities. Successful angioplasty and stenting of mid left anterior descending coronary atherosclerosis with thrombus see report for details. Patient recovered in hospital and discharged home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Three days after shot (second Anthrax shot) left bicep is swollen and sore. Red mark/rash covers arm/bicep from elbow to armpit. Itchy and burning sensation. Sharp pain in arm. Patient received shot because of ?Mleorn?
she had a feeling that she had a UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (she had a feeling that she had a UTI) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch nos. 8058081 and AS7185B) for COVID-19 vaccination.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:high cholesterol on Welchol, mild SVT mild Flecainade acetate, osteoporosis (officially diagnosed last year or early this year, previously osteopenia) started on Alendronate - previously osteopenia.  Previously administered products included for Drug use for unknown indication: Moderna (1st Dose: lot number 024M20A) on 08-Mar-2021, Moderna (2nd Dose: lot number 013A21A) on 05-Apr-2021, Moderna (3rd Dose: lot number 017F21A) on 25-Oct-2021, Moderna (4th Dose: lot number 058A22-2A) on 04-Jun-2022, Moderna (5th Dose: lot number 055F22B) on 03-Oct-2022 and Flu vacc on 26-Sep-2023. Past adverse reactions to the above products included No adverse reaction with Flu vacc, Moderna, Moderna, Moderna, Moderna and Moderna. Concurrent medical conditions included Hypercholesterolaemia, Supraventricular tachycardia and Osteoporosis.   On 11-May-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 05-Nov-2023, received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced URINARY TRACT INFECTION (she had a feeling that she had a UTI). The patient was treated with SULFAMETHOXAZOLE on 08-Nov-2023 for UTI, at a dose of 1 dosage form every twelve hours. At the time of the report, URINARY TRACT INFECTION (she had a feeling that she had a UTI) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Nov-2023, Urine analysis: diagnosed to have UTI.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 07-Nov-2023 to 08-Nov-2023, the patient had a feeling that she had a UTI. She started taking treatment, but she recalled that when she took the previous vaccines, she was told not to take any medication for headache or any antibiotic. The patient asked if there have been studies that show that the effect of the Spikevax can be nullified by the antibiotic that she was currently taking.
Patient reported needle phobia to pharmacist administering vaccine and received the injection. After receiving vaccine, patient vomited a little bit in restroom. He informed another pharmacist and stated that he vomits after every vaccine, blood draw, or finger prick and he was not concerned but wanted us to be aware. Patient proceeded to waiting room and did not need any additional assistance or interventions.
10-14-09 @ 09:30 - received inoculation right deltoid; 10-14-09 @ 17:00 - began aching to right lower arm with some muscle fatigue of right arm.  10-15-09 @ 06:00 - awoke with aching/muscle fatigue right arm, right side to right leg - no weakness.  No erythema or bruising.
20 to 30 yrs old & was vaxed w/2nd dose of MMR & lab eval revealed neg titers; No further detials were provided; nurse reported 8 pts;
Patient received FLUZONE on 11/13/12. Suffered generalized tonic-clonic seizure 11/18/12. Hospitalized; work-up includes abnormal EEG, but etiology remains unclear - clinically well since - no prior h/o seizures.
reaction at the injection site; temperature variation up to 102F/having fever 12 days after; no appetite; very sick like he had flu symptoms; tired and wanted to lay down; This is a spontaneous report from a contactable consumer(caregiver). A male patient of unspecified age and gender received bnt162b2 (PRIZER BIONTECH COVID-19, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had an acute reaction to the Pfizer vaccine. wondering about taking the 2nd dose. first and second day had normal reaction at the injection site, then started to have temperature variation up to 102 F, no appetite and very sick like he had flu symptoms, tired and wanted to lay down. He was having fever 12 days after. Went to the ER, took scan of abdomen and samples of urine to find out what was wrong. Seems to think person had a reaction. Reporter did not confirm if it's an allergic reaction. The outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (no demographics provided). On an unspecified dates an unspecified number of patients were administered (oka/MERCK) VARIVAX that was improperly stored at temperatures outside the product insert. No adverse effects were reported. This is one of two reports from the same reporter. Additional information is not expected, as there was no consent for contact.
Fever on day of injection. Patient stated developing hives throughout body yesterday, continues to have intermittent hives.
Narrative:  2/8/2021 UTI, sepsis, hyperglycemia, staphylococcus, MRSA infection-discharged to hospice care from Medical Center 2/9, passed 2/11.
I had a strong reaction to the first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a strong reaction to the first shot) in a  patient of an unknown age and gender 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 VACCINATION COMPLICATION (I had a strong reaction to the first shot). At the time of the report, VACCINATION COMPLICATION (I had a strong reaction to the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Patient received ZOSTAVAX injection on 3/3/17. Patient called back on 3/5/17 and said site was swollen, red, heat to the touch and bruised at injection site. I called MD on 3/5/17 and they called patient and recommended TYELNOL and BENADRYL. patient to see MD on3/6/17 AM. Left msg with pt for update. Per MD ofc; no further treatment needed.
Second  vaccine given 3-4-21  on 4-21-21 was treated at  the ER for blood clot in right calf  .  My calf was tight  and a bit swollen.  My heart beat was rapid  with shoulderblade pain and tightness in chest.  Tightness and blade pain started on 4/20 pm with a hard calf.  Morning pain worse and leg was more swollen and warm
Patient developed about 1.5 weeks after receiving the vaccine rash on face, chest, back that is pruritic and burns with application of emollient.  She was seen on 6/4 and determined to have a dermatitis.  No change in ADL or new products to suggest cause of the rash.  She is being treated with oral antihistamines, topical steroids, vanicream.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of PROQUAD (Merck) (dose and route were not reported, lot # L007230 with expiration date 03-SEP-2016) that had been improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter (other linked case # 1511USA003443). Additional information has been requested.
Vaccine PCV13 - Shoulder joint pain and swelling of lymph nodes at the base of the neck both on the side of the inject (left). After two weeks red steaks along left clavicle. Naproxen-didn't help, Cephalexin - too early to tell.
Became lethargic. Developed fine rash over entire body, went totally limp, became cyanotic, stopped breathing. Immed personality change refused to nurse or be held. No longer eye contact, development reversals.
Red Rash at injection set. Slightly itchy. Approximately 2 inch diameter. Consistent with ?COVID ARM? describes in literature.
Rash developed on face and resolved. Hives developed on full body at 1300 and pt. came to clinic for evaluation.
Patient had onset of right calf pain and swelling several hours after receiving vaccine.  Was seen on 5/10 and diagnosed with right lower extremity DVT.
Nauseous,  chills, body aches, dizziness, diarrhea,  sleepiness, body heaviness
Redness and significant pain in injection site, starting day after 2nd Moderna Injection. Day three after, still pain and redness 6"  arm area.
vaccines that were administered to patients after excursion occurred; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. Information regarding the patients' medical history, historical drugs and concomitant therapies was not provided.   On an unknown date,the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002846, expiration date 23-JAN-2022 for prophylaxis (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported).  The vaccine was stored in a temperature of -10.2 degrees Celsius (C) for 1 hour and 53 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014950: US-009507513-2008USA014798: US-009507513-2008USA014951:
The patient is a 46-year-old male with a past medical history significant for previous smoking, hyperlipidemia only, who presented to the emergency room from an urgent care secondary to elevated troponin.  The patient got his 2nd dose of the Moderna vaccine on Thursday.  He began to experience some chills and shaking a few hours after receiving the vaccine.  Found out that his grandmother had passed away.  Drove down to this region.  Stayed with family and went down for the funereal.  Felt sick.  Had a number of fevers during this time. Began to feel chest pressure, cough.  This occurred for a few days, worse on Saturday.  Apparently some of the family members at the funeral were diagnosed with COVID-19 infection.  The patient went to the urgent care to be tested for COVID, was having chest pain complaints, and was referred to the emergency room.  At this point the patient is chest pain free, but had a troponin that went up to 1200.  EKG shows no dynamic EKG changes.  Currently feeling much better.  Two-dimensional echocardiogram shows mild reduced left ventricular systolic function.  EF around 40%, global hypokinesis.
This 15 yr old female subject was enrolled in a blinded study for the prophylaxis of genital herpes disease and herpes simplex virus type 2 (HSV-2) infection in healthy young females. Medical conditions at the time of the event included anxiety and depression. Concomitant medications included norgestimate + ethinyl estradiol (Ortho Tri Cyclen). The subject received IM investigation product single dose on 22Feb05, 15Mar05 and on 27Jul05. (site of injection was unspecified). The subject had been randomized to receive the comparator vaccine in this trial, a marketed formulation of Havrix (360 EIU + 0.25mg Al in 0.5mL). Lot number was HA221A2. On 09Aug05, 13 days after the third dose of investigational product, this 15 yr old subject experienced depression with suicidal ideation. She was hospitalized from 23Aug to 25Aug05. The investigator considered the events as medically important. The events were unresolved at time of reporting. The subject's father reported that the subject's depression worsened after his daughter started using birth control pills, which were prescribed for dysfunctional uterine bleeding. The investigator considered there was reasonable possibility that the depression with suicidal ideation may have been caused by investigational product. The investigator also considered the events to be possibly associated with the subject's medical conditions, anxiety and depression.
Fine red papular rash beginning at (R) elbow and generalizing to cover trunk and extremities.
First 2 days after vaccination, I had some injection site pain that was improving. Day 5 after vaccination, I developed lymphadenopathy on my left side with swelling into the chest area developing on day 6. Day 8 after vaccination, my injection site turned red and itchy and I began to have trouble breathing. I went to urgent care.  I saw P. A. She said that it was more likely that the difficulty breathing would be due to my asthma, but she could not recommend whether or not I should receive my second dose. She proscribed 20mg of Prednisone and refilled my albuterol prescription. About 20 hours later, my breathing is still difficult and my arm still itches.  We also discussed that the respiratory symptoms could be caused or exasperated by COVID-19, so I am waiting on results from a covid test.
Started with high fever (104 degrees), difficulty breathing and gradually turned into extreme swelling of the face (eyes tongue and mouth). Lasted for seven days, three of which I was hospitalized for. Multiple emergency room visits.
Injection site has become swollen, very red, raised, hot to the touch and painful.  I've applied cold compresses, cortisone cream, and taking Benadryl.
SEVERE HEADACHES, BODY ACHES AND PAINS, FEVER OF 103.9, CHILLS, SHORTNESS OF BREATH AND CHEST TIGHTNESS NAUSEA, VOMITING.
Administration Error relating to type of vaccine and amount of vaccine given. Patient received 0.5 mL of monovalent Moderna for a booster dose instead of bivalent moderna.
EMT incorrectly gave the patient Pfizer vaccine as a second dose, when patient should have received Moderna. Error occurred when EMT mistakenly took Pfizer vaccine out of cooler (which was next to the Moderna vaccines).
Syncopal episode 5 minutes after getting out of bed on morning after.  Fell and hit head with laceration and contusions
Pt recvd vax JUN92 & devel a burning sensation upon inject as well as soreness & or an aching sensation in the arm; heaviness in the arm;
Varicella vaccine given 7/1/13. Pt called 7/2/13 evening with arm swollen. Pt went to Dr (walk-in clinic) on 7/3/13. Prescribed BACTRIM and BENADRYL (Poss. cellulitis or allergic rxn). Arm blistered and drained.
C/o warmth / flushed.  Given a cold cloth and cold water. BP 101/67, HR 90. Declined to stay after 20 minutes. Symptoms resolved and released.
swollen lt leg, some edema in knee; some peri-reddness around inject site; lt lymph node enlargement-groin-denied; high temp, denied convuls, no shrill cry;
Patient complained of nausea, headache, lightheaded, upon examination I found a rash on his back and chest. I administered 25 mg of Benadryl. Patient stated soon after that he felt tired but he felt much better and I examined him and found rash to be gone and that he had overall improvement.
Continuous "bruised" tissue pain around dosage site; Continuous "bruised" tissue pain around dosage site; I recorded many other different symptoms; This spontaneous case was received on 19-Nov-2022 from other non-health professional (consumer) (reference number: SEQW22-05943) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in 2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose, route of administration, anatomical location, and indication: not reported). The batch number reported was not reported.  On 04-Nov-2022, an unknown amount of time after receiving Afluria Quadrivalent, the patient experienced continuous bruised tissue pain around the dosage site.   On an unspecified date in 2022, within 24 hours after receiving Afluria Quadrivalent the patient experienced many other different symptoms, measured by the patient's cardiologist at the cardiologist's normal annual appointment.  At the time of initial reporting, the patient had not recovered from the events of 'vaccination site pain', and 'vaccination site bruising'.  The outcome of the event of adverse event NOS' was not reported.  The reporter did not provide a causality assessment.  Company comment: A patient of unreported age or gender experienced vaccination site pain and vaccination site bruising an unknown amount of time after being vaccinated with the suspect Afluria Quadrivalent vaccine. Reportedly, within 24 hours, the patient experienced adverse event NOS. Information regarding the underlying medical history and concomitant medications has not been provided. Causality for vaccination site pain and vaccination site bruising is unassessable due to unclear temporal relationship. Causality for adverse event NOS is assessed as possibly related.; Sender's Comments: A patient of unreported age or gender experienced vaccination site pain and vaccination site bruising an unknown amount of time after being vaccinated with the suspect Afluria Quadrivalent vaccine. Reportedly, within 24 hours, the patient experienced adverse event NOS. Information regarding the underlying medical history and concomitant medications has not been provided. Causality for vaccination site pain and vaccination site bruising is unassessable due to unclear temporal relationship. Causality for adverse event NOS is assessed as possibly related.
Pain scale is 3/10 / spike up to 6-7/10 at times when he is asleep and rolls over; Left arm muscle pain/ seems to be getting worse; pain on injection site radiates down to his elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain scale is 3/10 / spike up to 6-7/10 at times when he is asleep and rolls over), MYALGIA (Left arm muscle pain/ seems to be getting worse) and INJECTION SITE PAIN (pain on injection site radiates down to his elbow) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 0211L20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain scale is 3/10 / spike up to 6-7/10 at times when he is asleep and rolls over), MYALGIA (Left arm muscle pain/ seems to be getting worse) and INJECTION SITE PAIN (pain on injection site radiates down to his elbow). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN (Pain scale is 3/10 / spike up to 6-7/10 at times when he is asleep and rolls over), MYALGIA (Left arm muscle pain/ seems to be getting worse) and INJECTION SITE PAIN (pain on injection site radiates down to his elbow) outcome was unknown.            Other relevant concomitant medication included statin.   This case was linked to US-MODERNATX, INC.-MOD-2021-066932 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066932:1st dose
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. An unspecified number of patients received GARDASIL that was improperly stored by being exposed to 34F for 3 days, 33F for 2 days, 34F for 2.5 days, 32F for 0.5 days, and 30F for 30 minutes. The dates of the temperature excursions were unspecified. The medical assistant stated the vaccines dropped down to 32 F and 30 F for a total of 13 hours on 02-AUG-2012. The temperatures listed for 34 F and 33 F were prior to 02-AUG-2012. GARDASIL (lot number 670049/1261AA, expired date 11-NOV-2013) administered on 06-AUG-2012, 07-AUG-2012, 08-AUG-2012 and 10-AUG-2012. GARDASIL (lot number 671006/1291AA, expired date 12-APR-2014) administered on 15-AUG-2012 and 22-AUG-2012. No known adverse effects. This is one of several reports from the same source. Additional information has been requested.