chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient diagnosed with an ear infection. The infection bothers the patient more in the left ear, but HCP stated it was worse on the right one; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR INFECTION (Patient diagnosed with an ear infection. The infection bothers the patient more in the left ear, but HCP stated it was worse on the right one) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history provided by reporter.     On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced EAR INFECTION (Patient diagnosed with an ear infection. The infection bothers the patient more in the left ear, but HCP stated it was worse on the right one). At the time of the report, EAR INFECTION (Patient diagnosed with an ear infection. The infection bothers the patient more in the left ear, but HCP stated it was worse on the right one) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication: Decongestive medication, antihistamine  Concomitant medication include  Cholesterol medicine.
Urinary incontinence, weakness, loss of speech, loss of mobility (couldn't walk), fever for almost 12 hours. Still has loss of cognitive function from before the second shot almost 2 months after. Alzheimer's worsened. Needs more help around the house.
Constant tinnitus; noticeable loss of hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23May2021 (Lot number: EW0185) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sulfonamides" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0164, Location of injection: Arm Left), administration date: 24Apr2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: TINNITUS (disability) with onset May2021, outcome "not recovered", described as "Constant tinnitus"; DEAFNESS (disability) with onset May2021, outcome "not recovered", described as "noticeable loss of hearing". The events "constant tinnitus" and "noticeable loss of hearing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jul2021) negative. Therapeutic measures were not taken as a result of tinnitus, deafness. Addition information: The patient didn't received other vaccine in four weeks. Other medications in twoweeks included men's mutivitamin, solgar brand. The patient covid prior vaccination was none. Known allergy included sulfonamides. No follow-up attempts are possible. No further information is expected.
Pain which he reported as being on a scale of 4 out of 5 /Soreness; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pain which he reported as being on a scale of 4 out of 5 /Soreness) and FATIGUE (Fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 42L20A and 023V120A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Hypertension and High cholesterol. Concomitant products included LISINOPRIL, HYDROCHLOROTHIAZIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN and CROMOGLICATE SODIUM (NASALCROM) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced PAIN (Pain which he reported as being on a scale of 4 out of 5 /Soreness) and FATIGUE (Fatigue). On 27-Jan-2021, PAIN (Pain which he reported as being on a scale of 4 out of 5 /Soreness) and FATIGUE (Fatigue) had resolved.        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.   Treatment medications were not provided by reporter.   This case was linked to MOD-2021-028027 (Patient Link).
t103, vomiting, cont crying all noc;went to ER sent pt to MD office;t99.7;
Pentacel was accidentally given without the liquid component, just the HIB part with sterile water/No AE; Initial information was received on 09-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to 2020SA246864.  This case involves a 2 months old male patient who received a  0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] accidentally without the liquid component, just the hib part with sterile water (lot UJ195AAA, expiry date- 12-Mar-21) via unknown route in the left thigh for prophylactic vaccination on 09-Sep-2020.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included PNEUMOCOCCAL CONJUGATE VACCINE (PCV) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination..  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).  The caller stated that staff person administered 0.5ml of Pentacel in the patient's left thigh today. She used sterile water to dilute the Hib component of the vaccine and that was injected.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
A report has been received from a physician via medical representative concerning a 30 years old female patient. Medical history, concurrent diseases and concomitant medications of the patient were not provided. During Oct-2013, FLUMIST QUADRIVALENT (intranasal) received. During Dec-2013, the patient was diagnosed with the flu. The outcome of the event of type A influenza/ a patient received FLUMIST QUAD in October and was diagnosed with the flu two weeks ago was unknown. The report was considered to be non-serious by the reporter.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 29-DEC-2014 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006682 with expiration date of 31-DEC-2015; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PCP discovered heart rate abnormalities during an examination for an ear issue. Doctor referred to a cardiologist and sought an Echo Cardiogram. Non rheumatic mitral valve insufficiency and non-rheumatic tricuspid valve insufficiency, pulmonary hypertension due to left heart disease is official diagnosis. Participant is due for continued tests in the next few weeks.
This non-valid spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not reported. On an unspecified date, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX subcutaneous injection (dose and route of administration were not reported; lot#M039318 with expiration date 20-SEP-2018; lot# N015476 with expiration date 18-MAY-2019; lot# M025867 with expiration date 24-MAY-2018), ZOSTAVAX subcutaneous injection (dose and route of administration were not reported; lot # N009777 with expiration date 03-APR-2018) and PROQUAD subcutaneous injection (dose and route of administration were not reported; lot# N016113 with expiration date 21-NOV-2018). Vaccines were reconstituted with properly stored sterile diluent. On an unspecified date, the vaccines experienced temperature excursion of 37 degrees Fahrenheit (F) for 45 minutes. There were no adverse effects reported. The reporter stated that there were no previous temperature excursions for administered doses of vaccine. The data logger was involved. There was no product quality complaint involved.
Pt was given Tdap and PPSV 23 at 11:20 am office visit. At about 5:00 pm patient states she began having symptoms of headache, fever, nausea, vomiting, body aches, and chills. As of 7-11-14 patient still has headache, arm pain and warm spot on arm.
Diaphoresis, pallor, staring spells, fussiness.  Admitted to hospital where he was eventually diagnosed with intussusception.  This was successfully corrected with air enema, confirmed by ultrasound.
Localized reaction at injection site, 9cm diameter, no SOB, no fever. Rx: Benadryl 25mg PO Q 6 hours, Hydrocortisone cream.
Following vaccine flu like symptoms and fatigue lasted 24 hours chest pain began the third day after they subsided on the fourth with no additional pain.
This spontaneous report was received from a physician refers to a child patient of unknown age. On 27-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported) instead of VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
RIGHT AFTER INJECTION; BLEEDING OCCURRED AND HUGE BRUISING AND A KNOT A ND SWELLING. I TOLD PT TO TAKE A ANTIHISTAMINE WHEN SHE GOT HOME AND APPLY A WARM WET WASHCLOTH AND ICE. I CALLED HER ON SATURDAY TO CHECK UP ON HER AND SHE SAID HER ARM WAS STILL HURTING BUT BETTER TODAY 9-29-18.
Pt. states she developed mild pruritus overlying the injection site, had a very faint,  erythematous, reticulated rash overlying the injection site. This became more urticarial. There was no treatment and is resolved at this time.
Large, purplish area of swelling (16cm x 8cm) at injection site.
the patient experienced an anaphylactic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002628 (Novavax).  A male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose number unknown, single (Lot number: EN6201) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "the patient experienced an anaphylactic reaction".  Clinical course: On 14Jul2022, it was reported that a patient started treatment on 05Feb2021 with Pfizer BioNTech COVID-19 vaccine at an unreported dose/frequency for an unreported indication. It was reported the patient experienced an anaphylactic reaction.  No follow-up attempts are possible. No further information is expected.
Monday night I got the vaccine. told my arm would be a little sore. Tuesday my arm was really sore and I was nauseated . I went to work, I couldn't find the information sheet on side effects. I googled it and nausea was listed. I was sick to my stomach all day. Got home and got the chills, did not feel good. I also had a headache. Went to bed and then woke up early the next morning sweating really bad. 6am I wen to get up and I fell into the wall. I lay back down and then the room was spinning in a circle and wouldn't stop. I almost blacked out. the spinning wouldn't stop. I tried to get back up and could barely walk, I was so dizzy. I turned my head a little and ended up vomiting severely. I called my mom to get my husband to come home from work. I couldn't stop throwing up. I panicked and had them call EMS. Paramedics said its likely the vaccine in my system fighting it. ER doctor didn't care about the vaccine and told me it was vertigo. I was given medication. The meds did not help. I was still dizzy. I was laid out in the hallway for 8 hours. I had a CAT scan and CT, I saw a neurologist and physical therapist that specialized vertigo. The physical therapist did some tests and the findings were that I did NOT have vertigo. I have never been sick like that ever. I told the doctor I couldn't stand without assistance when he wanted to send me home. He said he couldn't help me. I had the option of rehab but they didn't even diagnose me with anything so I opted to go home. I still cannot get up and function on my own. I tried to call my PCP but she's unavailable until 9/8. (today is 9/5).
Pt had a Vasovagal response to vaccine. Pt sat down and passed out, came to about 2-3 minutes after. Looked very pale and was very thirsty. Gave pt water and ice pack to cool body. Mom was present, 911 was called. No breathing issues, asked pt name and dob. and she was able to successfully answer. 911 came and They took vitals and after about 20 more minutes patient walked out.
Patients mother called today to report that pt had a "small orange sized" hard area that was pink on her left deltoid where vaccine was given, no reported fever but it is sore. Patient to take ibuprofen or Tylenol PRN and can apply ice to area and let provider know if symptoms worsen or do not resolve.
A nurse reported the occurrence of bumps at the inject site in a subject of unspecified age and gender who received an intradermal injection of Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On unspecified dates, the subject received injections of Engerix-B. The subject did not respond to the injections and was subsequently administered the vaccine intradermally. At an unspecified time post-immunization of the intradermal injection, the subject experienced bumps at the inject site. As of 9/25/02, the outcomes of the events were unknown. Comment: This report has been linked to report #A0381698A due to the same reporter. Multiple subjects in their 50's and 60's did not respond to the Engerix-B immunization series and were subsequently administered intradermal injections. Follow up on 01/16/02: "On unspecified dates, the subject received six injections of Engerix B.  The subject did not seroconvert and was subsequently administered an unspecified number of 0.1mL Engerix B "boosters". These "boosters" were administered intradermally.  At an unspecified time after the "boosters", the subject developed bumps at the injection site that did not hurt or itch.  Subsequently, the subject seroconverted.  The injection site bumps resolved after an unspecified period of time."
?Covid arm?  Red bumps appeared around spot where vaccine was injected approx 48 hours after dose 1. Itchy. Also had tough time sleeping which is rare for me. Maybe related.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-NOV-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R006209, expiry date 16-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Patient did not have any adverse reaction. We are reporting due to age of patient, We inadvertently gave the Moderna to a 17 year old. Patient did stay for the required 15 minutes had no reaction, We checked on him the next week and he was fine -no reaction.
5ml syringes that had been provided by Regulatory Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/16/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.3ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
Dizziness, Headache, Myalgia, sore arm at injection site Narrative: Per employee report: Had second dose yesterday (2/24). At 4:30 this morning (2/25) awoke with headache. Minimal improvement with Tylenol. Right arm hurts especially at injection site. Had some dizziness also, and aching in her right neck and shoulder. Advised to rest, hydrate, consult primary care provider if not improving, and restrict Tylenol to less than 4g/24h and 3g is preferable.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In March 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 09-JUL-2016, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Fever, headache, sore throat, muscle ache, chills, rash and swelling at injection site
Previous HSV1 infection (10 years ago) reactivated - oral cold sore 2 days after injection.  Day 1 post injection.  Feeling as if ?coming down? with something. Chills headache sweats .  Day  5. Cold sore persists and unwellness (not as pronounced or uncomfortable)
Fever of 100-102 all day, then spiked to 103.9 around 6:00 PM.
Area 6 1/2 x 7 1/2 cm erythema, warm and raised at injection site.
The evening of day 7 after Moderna Vaccine, upper arm itchy.  Morning of Day 8 arm itchy, red circle about 2 inches. Arm hot. Lump under red circle.   Dermatologist Dr  suggested using  Triamcinolone Acetonide Cream on Day 8.  The circle continued to grow over the course of 10 days to about 6 inches. Arm very hot - lump still evident.  Day 11 - itching begins on the inner shoulder. Circle now wrapping around the upper arm with tendrils of red moving around the arm. Feel "itchiness" inside my chest.  The initial injection site circle is now purple/red.  Arm still hot to the touch and "lump" still there. Day 11 took Benadryl over the counter, 1 pill, and am using Benadryl creme at the injection site.
No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 28-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000973: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
late after swelling and hot to touch, iced periodically, by evening did not want to move upper part of arm, husband called it a goose egg - it was round but close to size of chicken egg and very swollen -- could move arm and better by Saturday, it is Thursday now (over week later) and it is still hot to touch, red, and painful but I continue to use it and ice every now and then -- I haven't heard of anyone else last so long -- concerned that Im due for 2nd shot March 3!!!
NUMB ARM; HEADACHE; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient stated having no medical problems and have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced numb arm. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on MAR-2021, was recovering from headache, and numb arm, and had not recovered from chills. This report was non-serious.