chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lost hearing in his right ear; lost hearing in both ears; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Lost hearing in his right ear) and DEAFNESS (lost hearing in both ears) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040c214 and 038C21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD since 2007, Hypothyroidism, High cholesterol, Hypertension, Angina pectoris (Angina), Parkinson's disease, Asthma, Pre-diabetic, Overactive bladder (OAB) and Enlarged prostate. Concomitant products included LEVOTHYROXINE, ATORVASTATIN, SALBUTAMOL (ALBUTEROL HFA), LISINOPRIL, AMLODIPINE BESYLATE, PRAMIPEXOLE, HYDROCHLOROTHIAZIDE, TAMSULOSIN HCL, INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE HIGH DOSE QUADRIVALENT), FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA), FINASTERIDE, MIRABEGRON (MYRBETRIQ), BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for an unknown indication.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DEAFNESS (lost hearing in both ears) (seriousness criterion medically significant). On 27-Jun-2021, the patient experienced DEAFNESS UNILATERAL (Lost hearing in his right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Lost hearing in his right ear) and DEAFNESS (lost hearing in both ears) had not resolved.            Treatment medication were not reported.  Partial hearing in his left ear.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.   This case was linked to MOD-2021-241895 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Additional information has been requested.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 1-year-old patient who experienced swelling at injection site and redness at injection site. The patient received a dose sometime in 2010. Relevant medical history was not provided. The patient received other unknown immunizations (manufacturer unknown) at the same time as PREVNAR 13. The patient experienced swelling at injection site and redness at injection site in 2010. The patient's mom was told to apply ice to the site. The outcome for swelling and redness at injection site were unknown. No additional information was available at the time of this report. Follow-up Report (17Nov2010): This is a spontaneous report from a contactable physician. The physician reports that this female infant recovered from the events on an unknown date. Patient's current weight is 20 lbs 11 oz, with head circumference of 18 cm and a height of 28 and 1/4 inches. Child's physical growth has been normal and she has not failed to meet any developmental milestones since starting the medication. Developmental milestones history for Language/Speech, Emotional/Social, Fine/Gross Motor Skills, and Cognitive thinking prior to starting the medication were also reported as normal.
In the office gave the DTAP-IPV mixed with sterile water to two patients but did not give the HIB portion of the vaccine at all/ medication error due to not mixing the vaccine as prescribed with no reported adverse event; Initial information received on 22-Feb-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves 2 patient with unknown demographics who reported in the office gave the diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] mixed with sterile water to two patients but did not give the hib portion of the vaccine at all/ medication error due to not mixing the vaccine as prescribed with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine Suspension for injection strength, dose, expiry date: unknown lot U7311AA via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "In the office gave the dtap-ipv mixed with sterile water to two patients but did not give the hib portion of the vaccine at all/ medication error due to not mixing the vaccine as prescribed with no reported adverse event" (product preparation error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event in the office gave the dtap-ipv mixed with sterile water to two patients but did not give the hib portion of the vaccine at all/ medication error due to not mixing the vaccine as prescribed with no reported adverse event.   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.
shaky; my arm is very sore; off label use; Inappropriate schedule of vaccine administered; chills; fever of 100.4 degrees Fahrenheit; extreme pain from mid-elbow to wrist; cannot lift arm beyond 45 degrees; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (cannot lift arm beyond 45 degrees), PAIN (extreme pain from mid-elbow to wrist), NERVOUSNESS (shaky), PAIN IN EXTREMITY (my arm is very sore) and OFF LABEL USE (off label use) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021F21A, 028A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APREMILAST (OTEZLA) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced LIMB DISCOMFORT (cannot lift arm beyond 45 degrees). On 29-Aug-2021, the patient experienced PAIN (extreme pain from mid-elbow to wrist). On 30-Aug-2021, the patient experienced PYREXIA (fever of 100.4 degrees Fahrenheit). On an unknown date, the patient experienced NERVOUSNESS (shaky), PAIN IN EXTREMITY (my arm is very sore), OFF LABEL USE (off label use), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (chills). At the time of the report, LIMB DISCOMFORT (cannot lift arm beyond 45 degrees), PAIN (extreme pain from mid-elbow to wrist), NERVOUSNESS (shaky), PAIN IN EXTREMITY (my arm is very sore), CHILLS (chills) and PYREXIA (fever of 100.4 degrees Fahrenheit) outcome was unknown and OFF LABEL USE (off label use) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, Body temperature: 100.4 °F (abnormal) 100.4.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Significant follow-up received on 30-AUG-2021 : Updated events
urine is cloudy and had an unusual smell; urine is cloudy and had an unusual smell; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as senior) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. Medical history and concomitant medications were not provided. On 25Feb2021, at night, the urine was cloudy and had an unusual smell (happened twice at night). The outcome for the events was recovered on 26Feb2021 (reported as everything was back to normal).  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Within several days of shingles vaccine, developed poison ivy type rash on left rear shoulder blade. This was followed by severe sunburn like pain on skin (no visible rash) on left side from armpit to just below waist. After 5 weeks mostly gone.
Hard, red rash about 3-4 inches in diameter; Hard, red rash about 3-4 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Hard, red rash about 3-4 inches in diameter) and VACCINATION SITE INDURATION (Hard, red rash about 3-4 inches in diameter) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE RASH (Hard, red rash about 3-4 inches in diameter) and VACCINATION SITE INDURATION (Hard, red rash about 3-4 inches in diameter). At the time of the report, VACCINATION SITE RASH (Hard, red rash about 3-4 inches in diameter) and VACCINATION SITE INDURATION (Hard, red rash about 3-4 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Paracetamol. No concomitant medications were provided by reporter.   Reporter did not allow further contact
PT HAD VACCINE DONE ON FRIDAY, FRIDAY NIGHT STARTED C/O DECREASED APPETITE, REDNESS/WARMTH/TENDERNESS/SWELLING AT SITE, AND CHILLS, SYMPTOMS WORSENED ON SATURDAY AND SUNDAY WITH SWELLING AND PAIN NOTED UNDER LEFT ARM AND DOWN INTO LEFT BREAST, STATES THAT THE PAIN AT THE INJECTION SITE HAS IMPROVED BUT THE UNDER ARM AND BREAST PAIN HAS NOT IMPROVED EVEN WITH TYLENOL Q6 HOURS.
Swollen lymph nodes on both sides of the neck and flu-like symptoms with sore joints and fever.
Information has been received from a registered pharmacist concerning a patient who on 14-MAR-2008 was inadvertently vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The patient is not experiencing any known symptoms. It was noted there was no product confusion involved. A product quality complaint was not involved. Additional information has been requested.
slight headache before bed, woke up with severe chills/shaking at 11pm and temp was 99.  Had taken ibuprofen at 8pm so I took more at midnight.  Was restless and uncomfortable and then started vomiting at 12:30.  Vomited once every 60 minutes until 4:30am and there was nothing left to vomit.  In between vomiting episodes, my mind was racing and I it felt like I could not stop it from having crazy, wild thoughts.  almost hallucinogenic in nature and my temperature started rising.  Had to sleep sitting up a little bit and finally slept from 4:30-7:30am.  When I woke up my fever was 102 and I was achy and heavy feeling but no longer needing to vomit.  I sipped on some water and was able to take ibuprofen.  Temperature broke about an hour later (8:30am) and did not come back.  The rest of the day I felt nauseous, weak, and couldn't really think clearly at all.  When people would talk to me I felt like I could not comprehend what they were saying and it literally hurt my brain to try to use it.  The headache continued all day even with meds.  I was able to doze off and on and by nightime I could eat a few crackers.  No appetite but I did have smell and taste.  I was able to sleep that night and the following day I was able to sip water to begin to rehydrate.  Headache was gone when I woke up and the other symptoms slowly subsided and I felt like I had enegry again and an almost clear mind.
Pfizer injected to arm by nurse. They asked if I was pregnant. I indicated I wasn?t pregnant. A few weeks later I had a positive pregnancy test indicated I would have been pregnant at the time of the vaccine. High levels of HCG. On sept 6 2021 I had severe back pain, moderate bleeding , and after a confirmation from the ER doctor I had a miscarriage. Previously healthy. Unknown aetiology for miscarriage.
Flu like symptoms started (cough) took THERAFLU, severe shoulder pain, unable to move left arm took TYLENOL but did not help. Went to doctor on 10/17 no guidance given. Went to another doctor on 10/24 who is referring to orthopedic doctor for testing. Specified that might be issues with administration. Pain has diminished a bit over time but still not able to use arm. Needs help dressing and other activities that require use of arm (driving).
Information has been received from a registered nurse concerning a 65 year old female patient with no pertinent medical history and no known drug reactions/allergies who on 16-SEP-2009 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 vaccine (lot# 662785/1124X) intramuscularly. There was no concomitant medication. "12 hours after the vaccination", the patient developed rash and hives around the injection site. The patient also had fever of 103 degrees F, shaking, chills and tired. The patient was seen by the nurse. "Complete Blood Count test was performed and the WBC value was 12,400". At the time of the report, the patient was recovering. Additional information has been requested.
Pt was seen in clinic to get influenza and COVID vaccine. MA drew up COVID vaccine from a SDV that was labeled as 0.25ml which was the appropriate dose for her age. COVID and flu vaccine was administered. Later, RN was drawing up 2 move COVID vaccines for 2 other pts under ages 12years and found that there was more that 0.25ml in SDV labeled as 0.25ml. RN called Moderna the manufacturer and representative did confirm that they are overfilling this SDV more that 0.25ml to ensure that when drawing up, pt gets the full amount of 0.25ml. Representative was not able to tell RN the exact amount that each vial contains but did start a case on this. Pts mom and dad contacted communicated that pt could have received more than 0.25ml appropriate dose. RN had mom and dad observe pt injection site and there were no issues noted at this time. RN educated mom and dad to come into clinic for any concerns to local site reaction such as redness, heat or hardening to site. Educated to take pt to ER for evaluation for any systemic reaction to include; trouble breathing, swelling to throat, tongue, eyes, trouble swallowing, hives etc. Mom and dad verbalized understanding. RN communicated that RN will f/u with mom and dad on Monday to check on pt status.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 04-DEC-2012 was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Janssen COVID-19 Vaccine EUA Sudden, strong taste of old coppers pennies in my mouth.  Taste lasted the rest of the evening.
Pt states feels warm after sitting a few minutes.  PT monitored, VS at released from observation area were normal for this patient.
Information has been received from a licensed practical nurse concerning a 45 year old male patient who on 11-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot number: 665270/1398Y) intramuscularly in the left deltoid. The patient woke up on 12-SEP-2010 with severe pain in left shoulder with no relief from ADVIL. There was no redness, pain, swelling at the injection site. The patient sent for MRI, on 01-OCT-2010, which showed no evidence of full or partial thickness rotator cuff tear, mild subacronial / subdeltoid bursitis. Moderate degenerative change, capsular thickening left acromioclavicular joint, type II curved acromion. Edema left acromioclavicular joint, capsular edema, different above. At the time of the report the patient's present status was unknown. Additional information has been requested.
1-5 minutes after the shot I got a pain on the left arm and I ignored it since I was on the phone and I had received the vaccine on the right arm. I got to my car after buying something at Walgreens and I felt a pain on my leg but I also ignored it . I got home and since then I have been feeling like something is pinching me mostly on arms, legs, fingers and toes. Once it happened on my finger and it was more intense than usual and I saw my vain popping up and it was a little purple. It went away after a few minutes and today I felt that on my arm and it was also more intense than usual and I also saw my vein popping up and the area showed a big bump . It went away right now (about 7 hours later ) I only have a very tiny bump in that area. I also felt a pain kind of like cramps on my right leg and pain on certain area on my feet and I feel it when I walk . I have felt something in my head also but it feels more like small needles and it is not a headache .  I don?t know what to do regarding the second shot and I tried to see a specialist right away but they need the blood tests in order to help me . I will see a doctor on 7/30 and hopefully get the order for the blood tests soon so I can see the specialist. Other than that I have been feeling tired but I understand that this is a normal symptom.  I do have pictures if you need them and I can also share information about my blood tests with you and once I see a specialist I can ask him to complete this report.   If you have any suggestions please email me since what  concerns me is that I believe that this has to do with blood clots and I know that this can turn into a Really bad situation.   Thank you
06/01/2022 In the early afternoon started to feel feverish, dizzy, and very fatigued. I did not have any other symptoms other than sweating and freezing of and on. At night I had no appetite and slept for a while and was still extremely cold after falling asleep. 06/02/2022 Additionally my nose started running, I developed a terrible cough, low grade fever that is still continuing, and overall fatigue. 06/03/2022 met with my doctor today and was given prescription for PAXLOVID. The cough and cold like symptoms gone away however my headache is still present.
Patient describes a sensation of tingling/burning on the edges and front of his tongue accompanied by a bothersome taste (like soap or a chemical) that has occurred intermittently since receiving his vaccine dose 1. Since 1/28/2021 when he got dose 1 of the Moderna vaccine, he has experienced this sensation somewhere between 5-8 times. Each episode lasted from 1 hour to most of a day. The episodes have only varied in duration but not in nature or severity. The patient has typically tried to drink and/or eat something to mitigate the sensation with some success.
patient felt tired and light headed. Takes high blood pressure meds + suffers from anxiety.  Was mostly feeling very tired woozy/ lightheaded Has a history of instantly feeling sick after a few things Claims not to have any anxiety issues or concerns Is diabetic & had a bit of high blood pressure No heart issues or anything No nausea Already had Covid in November  Allergic to some medication-EMS saw no major concern Blood pressure was verified high Takes hypertension meds
Patient is 38 years old and should have received the Fluarix not the high dose Fluzone.  Patient was notified by phone when error was discovered.  No adverse symptoms reported by patient on 10/10 at phone call follow up
Following administration of Vaccines, patient experienced decreased BP (76/47), syncope, vomited x2 (clear bilious) and blanching of skin around eyes and to fingers of hands bilaterally. Cheeks and dorsal surface of hands became erythematous. Patient placed in supine position with LE raised. BP retaken 86/50 HR 90 O2 Sat=98% - no noted respiratory distress and lungs clear but mentation decreased, "dazed" appearance with blanching to periorbital area and fingers bilaterally, and erythema to cheeks and dorsal surface of hands remaining. BP retaken after lying supine for 10min - 92/47 but when taken to standing BP decreased to 76/48 HR 90 O2Sat=100%. Mentation remained decreased and "dazed" appearance persisted. 911 called after 40 minutes of efforts to stabilize unsuccessful - EPIPEN and Diphenhydramine administered. Dr. at ED called and report given. Transported to ER at ~1045hrs via EMS.
Rash - Information has been received from a registered pharmachist concerning a patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) or measles virus vaccine.  Ten days later, the patient experienced a rash.
This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-month-old female patient who received HAVRIX (batch number 59D74, expiry date 9th December 2014) and (batch number 59D74, expiry date 5th February 2016). On 9th December 2014, the patient received the 1st dose of HAVRIX. On an unknown date, the dose was an unknown dose. On 9th December 2014, an unknown time after receiving HAVRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information: HCP called to report that they gave an adult dose of HAVRIX to a 2 month old patient. They meant to give the patient PEDIARIX. They said the nurse chose the wrong product by accident. As of now, no adverse events have been reported by the patient/parent.
Initial misuse report received from a healthcare professional on 08 August 2013. A 15-month-old patient receiveed Act-HIB vaccine reconstitute4d with DTaP/IPV component of PENTACEL. DTaP/IPV was not to be administered to the child. No adverse event was reported. List of documents held by sender: none.
Brain tumor. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.