chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sudden loss of hearing in left ear; Pressure in ear; Aches/Pains; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (Sudden loss of hearing in left ear), EAR DISCOMFORT (Pressure in ear), PAIN (Aches/Pains) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Interstitial lung disease since 26-Dec-2019. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID) from 1965 to an unknown date for Hypothyroidism, CALCIUM from 2010 to an unknown date and VITAMIN D3 from 2010 to an unknown date for Osteoporosis.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN (Aches/Pains) and CHILLS (Chills). On 26-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Sudden loss of hearing in left ear) and EAR DISCOMFORT (Pressure in ear). The patient was treated with PREDNISONE on 26-Apr-2021 for Partial hearing loss, at a dose of 50 mg once a day. On 07-May-2021, DEAFNESS UNILATERAL (Sudden loss of hearing in left ear) and EAR DISCOMFORT (Pressure in ear) had resolved. At the time of the report, PAIN (Aches/Pains) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Acoustic stimulation tests: (Inconclusive) confirmed partial hearing loss in left ear.. On 05-May-2021, Magnetic resonance imaging: unknown (Inconclusive) showed no tumor or other abnormality.. On 07-May-2021, Acoustic stimulation tests: (Inconclusive) showed hearing restored..         Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   This case was linked to MOD-2021-117984 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Updated the reporters details, patient past medical history, laboratory data, concomitant medications and treatment drug added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Apr2023) very faint T line; (10Apr2023) very faint T line. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The patient was treated with Paxlovid from 24Mar2023 to 29Mar2023. Positive rapid test 11 days after finishing Paxlovid. The patient has no known allergies.  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.
vaccine ran down the patient's arm during administration; vaccine ran down the patient's arm during administration but patient got most of the vaccine; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case, from a pharmacist.  This case involves a female patient of an unknown age who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6686NA, expiry date: Jun-2020), via unknown route in the arm  not otherwise specified (NOS), on 20-Nov-2019.  Medical history, medical treatments, vaccinations and family history were not provided.  It was a case of actual medication error due to vaccine underdose. It was also a case of Exposure via skin contact.  t was reported that the pharmacist administered Fluzone Quadrivalent on 20Nov2019 and the vaccine ran down the patient arm during administration (Preferred Term: Syringe issue and Preferred Term: Underdose). The dose to be given was 0.5ml. The pharmacist feels as though the patient got most of the vaccine. Patient stated the liquid that ran down her arm was clear with blood per the usual.  At the time of reporting, the patient had no 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 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.
Redness, swollen, & rash around vaccine area notice on 2/6/09 taking bath, on 2/7/09 & 2/8/09.  The rash went away redness swollen 7cm x 6cm on 2/9/09
1 day past, Arm swelling and not felling well. 2nd day passed, arm swelling more and lymph nodes in neck swelling. Feeling sick, told to take benedryl.
Pt recv vax on 11/23/98; 20 min post vax pt exp red, swollen eye; itching; rash; wheezing; tx=Benadryl
feel really sick; diarrhea; dizziness; nausea; chills; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (feel really sick), DIARRHOEA (diarrhea), DIZZINESS (dizziness), NAUSEA (nausea) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (feel really sick), DIARRHOEA (diarrhea), DIZZINESS (dizziness), NAUSEA (nausea) and CHILLS (chills). At the time of the report, ILLNESS (feel really sick), DIARRHOEA (diarrhea), DIZZINESS (dizziness), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        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.   concominant medication was not provided. Treatment medication was not provided.
it gave me the flu both times; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer / non-health care professional.  This case involves a patient of unknown demographics who reported that it gave me the flu (influenza) both times, while the patient received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, route in unknown administration site unknown) for prophylactic vaccination.  The patient developed the flu both times (influenza) following the administration of influenza vaccine.  No laboratory test was reported.  It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for gave me the flu both times.  There will be no information available on the batch number for this case.
SX's started at 7 pm...stiffness in neck, then to all muscles and joins flu like sx's  through bedtime  on 4/24/19 diarrhea 4/24 at 11:30 am - 1:30 pm  same day slight tingling in random sites on body
She started having panic and anxiety the following day after she had the vaccine. It hasn?t stopped yet. She doesn?t want to be alone and having trouble sleeping.  Her stomach also has been bothering her off and on .  She has never experienced anxiety before.
Day 1: no sx, Day 2: extreme fatigue . Dizzy lightheaded Day 3: profound lethargy + dizzy & lightheaded . bedridden Day 4: profound lethargy dizzy + lightheaded  bedridden Day 5: visit to urgent care. rx for keflex for injection site sub cutaeneous lump. c/o right arm swollen, petechia, right torso petechia. dizzy lightheaded. Patient reports she is blood type AB negative Day 6: visit to PCP
Arm  is sore; Arm  swollen; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Pfizer vaccine with an associated reaction of herpes zoster and Shingles vaccine (1st dose received more than 10 years ago).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm  is sore) and swelling arm (Verbatim: Arm  swollen). The outcome of the pain in arm and swelling arm were not reported.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and swelling arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient got shingles 5 days after he/she had the first Pfizer vaccine shot.  More than 10 years ago the patient had the first shingles vaccine, but have been advised he/she need the new one so, patient just gotten the first shot a few days ago.  The second shot will be in two months.  The patient arm was sore and a bit swollen but no major side effects so far. The patient stated that no one wants to get this disease. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
From ER History and Physical: Initial Greet Date/Time 05/23/19 0959  Presentation  Chief Complaint Rash  Context  Additional Context  1yo with PMH prematurity at 25 wga presents with 1 week history of low grade  fever, cough and now rash. Mom brought her in for poor PO and rash. Of note,  patient had MMR vaccine 9 days ago. Per mom, rash started on face then spread  downwards and coalesced.
My first dose on 10-14-20 did not have any adverse effects, but the booster dose on 12-14-20 hit me everywhere.  That evening, I had pain on my entire left side since the Shingrix  dose was injected in my left arm.  Pain, aching all over, tiredness, and very sleepy for five days.    I have not been able to walk out for the mail  or drive anywhere since my arms hurt too much to raise.
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: pt reportes left side of face numbness (left side nose & eyes feel heavy, tingling of left finger tips, center of tongue feels numb
Day 8 (11/7/22) after injections, severe hives cover 50% of the body.  Mostly in the genital area and neck/scalp.  Tried OTC creams and antihistamines with no improvements. Prescribed oral and cream steroids on day 4 of hives (11/10/22)
Patient is describing that her arm is very sore for the past week since the shot. She is feeling very weak with headache, OTC meds are not helping. She states she has never been this sick ever.
I had Moderna shot #2 on Monday morning, Feb 22, 2021. The next day I was brushing my teeth and noticed I could not spit as usual. Then Wed, Feb 24, my left eye drooped down and I could not control it. Also, the left side of my mouth drooped. I could not control it either. Difficulty eating. Went to Urgent Care Monday, March 1. They sent me to ER where doctor diagnosed me with Bell's Palsy.
Client received first dose of Pfizer Covid 19 Vaccine in left  Deltoid; Client complained of tingling and numbness in fingers of left hand 10 minutes into waiting time after the vaccine.
Acute renal Injury 2 weeks after vaccination.  Resolved. sore Throat, Flu like symptoms beginning one day after vaccination. Lasting 7 days.
Headache, Tiredness, bodyaches, very warm feeling inside body day of shot. Today is day two  symptoms seem worse and develop the 100.9 fever till next morning. Entire body of  bones and skin is aching. Breathing is shallow and my ribs are hurting, when I move I get sharp pains as well in the rib area or what organs are under the ribs.  I could hold my bladder when I got out of bed. I didnt know I was urinating myself until I felt it going down legs.
Extreme fatigue and muscle and body aches; slightly elevated body temp, loss of appetite, slept 15-18 hours
SORE THROAT; INTENSE COUGH; FELT SICK; HEADACHES; SOME FORM OF NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. In this scenario follow-up is not required to obtain batch/lot numbers. No concomitant medications were reported.  On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced intense cough. On APR-2021, the subject experienced felt sick. On APR-2021, the subject experienced headaches. On APR-2021, the subject experienced some form of nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt sick, some form of nausea, headaches, sore throat, and intense cough. This report was non-serious.
This medically confirmed literature report (initial receipt 04-Feb-2014) concerns a 34 year old male patient who had no history of recent travel or exposure to insects. His sibling had a history of HIV (human immunodeficiency virus) with Hodgkin's lymphoma. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient presented with bilateral facial weakness and difficulty drinking. He had lower extremity tingling sensation and was evaluated at the emergency department one week before presenting. He had no complaints of extremity weakness, no changes in vision and hearing and no history of fever or headache. He received the flu shot ten days before presentation. On examination, the patient was found to have bilateral lower motor neuron facial palsy with Bell's phenomenon but no other focal neurological deficits. His white blood cell count was elevated to 13.18. An MRI (Magnetic Resonance Imaging) of the brain showed four millimetre lesions in the left centrum semiovale demonstrating enhancement and two other non-enhancing lesions in the body and splenium of the corpus callosum. A lumbar puncture showed a high white cell count containing all lymphocytes and monocytes with elevated protein. A presumptive diagnosis of neurological Lyme's disease was made and the patient was started on intravenous ceftriaxone. However Lyme antibody, blood and CSF (cerebrospinal fluid) Lyme PCR (polymerase chain reaction) were negative. Serology for syphilis, West Nile virus, HIV, VZV (varicella zoster virus) were also negative. Cryptococcal CSF antigen was also negative. Serum ACE (angiotensin converting enzyme) level was within normal limits. The patient had gradual improvement of his facial weakness. He was treated with a rapidly tapering course of prednisolone for six days. He received ceftriaxone for 14 days intravenously. His facial palsy had nearly completely resolved. Outcome was reported as recovering. Reporter comments: Literature reviews showed most of bilateral Bell's palsy are caused by Lyme disease, sarcoidosis, HIV and EBV. There was a single case reported after intranasal influenza vaccine but no case reported after inactivated flu vaccine injection.
Information has been received from a pharmacist and nurse midwife concerning an adult female who was vaccinated with a dose of VARIVAX (Merck) (lot number unknown) and developed a mild varicella rash after administration of the vaccine. No further information was available.
Patient came in the following Saturday on December 1st and showed the pharmacist that she had a reaction in her right arm to the PNEUMOVAX 23 vaccine that began the evening of the vaccine date.  She reported a large swollen, red area that went around and down her arm. She also had some bruising that she had him look at. The pharmacist advised her it may be a localized reaction and that she should keep an eye on it and keep us posted. She came in this week to show the improvement and we advised her we would report to VAERS. The patient did not indicate that she took any OTC medications for treatment
Patient did not receive the second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive the second dose) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032h21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive the second dose).    No concomitant medications were provided. No treatment medication was provided.
Palpitations, "heat" a few minutes after vaccine, lasted only a few minutes. Tolerated second dose with no symptoms.
Pt recv vax on 1/14/99; on 1/24/99 pt exp rash & welts; tx=Prednisone, Benadryl & Allegra
Fever, chills, and fatigue that started February 9, were worst on the night of 2/9 into 2/10, and appear to be clearing up as of 2/11.  I have not had in-person contact since my shot on 1/22, and get my groceries through no-contact delivery.
5 days p/vax pt devel stiff neck lasting 1 1/2 wk;saw chiropractor w/o relief;devel local lymphadenopathy;referred by PMD;16JUN98 pt reports arm was red & itchy for 4-5 days p/vax;
Pt states that she started feeling intermittent shortness of breath 3 days after COVID vaccine
PRESENTED WITH GENERALIZED RASH ONSET 05/11/2006. DX: VARICELLA.
Skin itchiness that came suddenly about 2 weeks after my Moderna booster.  Itch is on different parts of the body, and changes throughout the day. When the skin is scratched red raised lines appear (dermatographia). The itchiness is severe unless antihistamines are taken. It's been ten days and no relief.
eyes-burning, itching, watering, eyelids some swelling;throat c/o tightening et felt like it closing;rash-chest;some redness & swelling @ site;took DPH;seen by MD;
Arm was sore for about 36 hours after the injection.  Then arm began to itch just over a week after the injection. Was a little itchy for a couple days.  Also had a light red, slightly swollen rash around the area (2-3 inch diameter) that was warm to the touch.  Seems to have faded 48 hours after the itching began.
First noticed on 12/10/02. Reddened left arm on 12/11/02. Applied cold compress. Have been using. Fever noted on 12/10/02 of 101F-101.2F. Moving the arm but has a welt approx. 2" wide. Called on 12/13/02, no answer, but at 16:05; no temperature and redness decreased on arm per mother.
cellulitis; pt devel erythemia, edema & temp; pt seen in ER 7NOV94 dx w/cellulitis & tx w/Keflex;
38 year old received the FLUARIX on the rt. deltoid area IM on 11/4/08. 3 days later she returned to the health department c/o Rt. deltoid area pain (8 on 1-10 scale), local tenderness, mild swelling, numbness throat radiated distally and ROM, and paroxysmal tachycardia. Pt was advised to cont. taking Ibuprofen, warm compresses, and see her primary care provider for further evaluation. Pt. returned on 11-10-08 c/o minor changes and improvement. Referred to PCP.
had the first dose of the pfizer covid 19 vaccine and both experienced arm pain; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included aspirin [acetylsalicylic acid] (baby aspirin every day) taken for an unspecified indication, start and stop date were not reported. The patient states that had the first dose of the pfizer covid 19 vaccine and both experienced arm pain on an unspecified date. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Normal menstrual cycle from vaccine dose until July 15, when bleeding started. I use a period tracker app and according to my app, this was day 19 of my cycle and I should have been ovulating on this day. I do not have any possibility of being pregnant, and symptoms were consistent with a 5 or 6 days-long period, which is normal for me.  Was seen by Dr. on 8/26 and was advised to wait several more cycles to determine if there was an issue that needed further examination.   As of August 11, my menstrual cycle since then has been normal, so far. Ovulation was predicted within +/- 1 day from app and symptoms during ovulation were typical for me.  I am expecting my period to start in the next several days.   My menstrual cycle is typically 31-35 days in length and since 2014 (when I started tracking), I have never had a menstrual cycle shorter than 28 days.