chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever went up to 37 degrees celsius at 10.30 am, about 18 hours after vaccination. Shortly after a strong headache arose. I became very weak and felt bad for the whole day 27th  may. I woke up this morning with all the above symptoms disappeared.
Swelling and redness from about 4" above the elbow down to about 4" above the wrist. Associated with pain and elevated blood pressure.
Hearing loss in both ears, worse in left; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS BILATERAL (Hearing loss in both ears, worse in left) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided). Concomitant products included PROBIOTICS NOS, VITAMIN D3, VITAMIN B12 NOS and BIOTIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form(s). On 07-Apr-2021, the patient experienced DEAFNESS BILATERAL (Hearing loss in both ears, worse in left) (seriousness criteria disability and medically significant). At the time of the report, DEAFNESS BILATERAL (Hearing loss in both ears, worse in left) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Acoustic stimulation tests: hearing loss (abnormal) Hearing loss.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Thyroid medicine. Patient experienced hearing down on the right side of the ear. It was buzzing at first. Patient started taking Prednisone on 13-Apr-2021 and had to take it for 18 days.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Pt developed chicken pox like rash with only a few scattered lesion and also developed a slightly rough generalized rash over most of body.
Multiple blood clots in right leg (DVT) and multiple blood clots in lungs (PE)
57 y/o F w/ PMh of significant for CVA s/p L hemiplegia, CHrEF, recurrent DVTs/PE who was recently admitted for leaking PEG tube, got it replaced and was discharged back to care center. The patient was doing much better, getting much more oriented tolerating tube feedings oxygen saturations had been normal and not requiring much oxygen. Unfortunately patient contracted coronavirus at the rehabilitation center from the other resident. Patient did qualify for the monoclonal antibody
Swollen upper extremities bilaterally and Bilateral ankle swelling. Noticed symptoms after receiving immunizations.
Fatigue lasting more than 24 hours. Diarrhea around 8:00 pm on 4/25 (took loperamide 4mg). At 8:33 pm, no more diarrhea.
Pt developed a large knot where Prevnar was administered. When examined the knot was approximately 1" in diameter with discoloration. Pt also had vomiting. Pt was diagnosed with adverse reaction/hematoma.
Client reports "hive-like" rash to chest the size of a inch, onset approximately 2 weeks after dose 1. Reports widespread "hives" to chest, ribcage, and shoulder blades onset 2/6/2021. Reports first attributed the reaction to a new necklace/nickel allergy. Prescription steroid cream to site has helped with symptoms.
Patient fainted and hit door/wall attempting to stand. She mentioned having prior history. Pharmacy made her sit down for 10-15 mins and offered icepack/aid which she declined.
Case number PHEH2013US0008935 is an initial spontaneous report received from a nurse on 17 Apr 2013. This report refers to a male patient. His medical history and concomitant medications were not reported. It was reported that on an unspecified date he was vaccinated with 0.5 ml MENVEO (batch number: M11081, expiry date: Apr 2014) intramuscularly and did not receive MenA lyophilized conjugate. No adverse reactions were reported. No further information was provided.
Temperature excursion with no reported AE; influenza vaccine may not be effective with no reported AE; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 58 years old female patient to whom event Influenza quadrival A-B vaccine [Fluzone quadrivalent] influenza vaccine may not be effective after temperature excursion with no reported adverse event (AE)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided and had no concomitant disease or risk factor.   On 20-Oct-2021, the patient received a dose of suspect Influenza quadrival A-B vaccine, Solution for injection in pre-filled syringe lot UT7680NA via intramuscular route (unknown dose, strength and site) for prophylactic vaccination after temperature excursion with no reported AE (product storage error) and influenza vaccine may not be effective with no reported AE (poor quality product administered) (latency: same day)  There were no lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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 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.
This case was reported by a other health professional via call center representative and described the occurrence of respiratory disorder in a patient who received FLUARIX quadrivalent. In 2015, the patient received FLUARIX quadrivalent. In 2015, less than a day after receiving FLUARIX quadrivalent, the patient experienced respiratory disorder. On an unknown date, the outcome of the respiratory disorder was unknown. It was unknown if the reporter considered the respiratory disorder to be related to FLUARIX quadrivalent. Additional details were provided as follows: The healthcare professional reported that one patient experienced respiratory issues and was taken to emergency room for treatment with 24 hours after receiving the FLUARIX quadrivalent. The healthcare professional also reported that multiple patients who received the FLUARIX QIV complained of abnormal swelling and rash at the injection site within one day after receiving the vaccine (see case US2015162512). The healthcare professional initially called to inquire if there had been a change in 2015 year's formulation or if there had been an increase in reports of these type of adverse reactions with patients receiving FLUARIX QIV. The healthcare professional reported that she was not having access to further patient identifiers or product details at the time of reporting. No further information was reported regarding the event.
Vaccine given at 10:30 and 2 hours later, pt experienced perspiration, unable to get up from chair and nausea. Taken to hospital by EMS.
Immobility Left shoulder, upper arm and especially upper back/left side near centerline due to pain. Cannot take full breath due to this. Self medicated with Meloxicam 1@15 mg and Diclofenac topical gel (both prescribed for occasional use). Pain has subsided from 8/10 to 5/10. Mobility has improved to 50% normal at 1200 local time.
Was also incoherent /remember who she was or what her children's names were or grandchildren's names; Very sick; Super high fever; Had Sweats; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0176), dose 1 via an unspecified route of administration, administered in Arm on 20May2021 10:00 (at the age of 68-year-old) as DOSE 1, SINGLE for covid-19 immunization. Medical History: The patient had underlying conditions. The patient had two mechanical heart valves from 5 years ago. The patient had 2 knee replacements. The second knee replacement was in Feb2021. The patient recovered from the second knee replacement and was outpatient PT. Two weeks before the first dose Pfizer Covid 19 Vaccine, the patient said for the first time in years she did not have any kind of knee pain of any kind, other than regeneration of nerves, no bone pain from the replacements. The patient was doing so well. There were no concomitant medications. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No any other vaccinations taken within four weeks prior to the first administration date of the suspect vaccine(s). The patient got vaccinated as a child, the age bracket. The patient had flu shots and shingles shots, all of them were given with no adverse reactions other than the patient's arm hurt. The reporter states his wife was fixated on having to have the vaccination card. The patient received the first dose Pfizer Covid 19 Vaccine on 20May2021 and became very sick, very ill. On 20May2021, the patient experienced Very sick, super high fever, sweats which began the same night, and this lasted for about 2 days. The patient was also incoherent. The caller stated his wife was also incoherent after receiving the first dose Pfizer Covid 19 Vaccine. The patient couldn't remember who she was or what her children's names were or grandchildren's names. The patient kind of recovered for 4 days. AE(s) did not require a visit to: Emergency Room/Physician Office. Relevant Tests were none. The outcome of events very sick, Super high fever and Had Sweats was recovered on 24-MAY-2021. The outcome of event was also incoherent /remember who she was or what her children's names were or grandchildren's names was unknown.  No follow-up attempts are needed. No further information is expected.
Chills, nausea, body soreness, headache 2:00 am-6:30pm 4/17/2021 Nausea headache 4/18/2021 all days
Break-through COVID; Break-through COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Feb2021 (Lot number: EL3247) at the age of 53 years as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "recovering" and all described as "Break-through COVID". The event "break-through covid" and "break-through covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (24Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Prior to Covid-19, no vaccination was provided. No known allergies and no other medical history was provided. No other vaccine was administered in four weeks and no other medications in two weeks.   No follow-up attempts are needed. No further information is expected.
PATIENT WAS GIVEN A COVID VACCINE ON 09/23/2021 AND COVID EXPIRED ON 09/17/2021
Moderna COVID-19 Vaccine EUA. On 01/10/2021 states she was feeling fine and when she answered the phone her son noted that she was slurring her speech. Her husband was home at the time and she was taken to the hospital.  CT scan and MRI  completed and showed an ischemic stroke. She states she still occasionally slurs her speech and sometimes loses her balance so she now walks with a cane. She is now on 2 medications for blood pressure and is also on plavix. She had mentioned to the physicians that she had received a dose of Moderna on 12/29/20. She went on to receive her second Moderna  on 1/26/2021 and a booster of Pfizer on 12/10/2021 with no side effects to date.
A dose of Pediarix vaccine was given on 10/19/2005.  The expiration of vaccine was 10/15/2005.
Sore Arm; swelling arm; This spontaneous report as received from a pharmacist referring to a 70-year-old male patient. The patient's historical medications, concurrent conditions drug allergies or reactions were not reported. His concomitant medications included losartan potassium (manufacturer unknow).  On 29-SEP-2020,  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  0.5 milliliter, intramuscular, once for prophylaxis, lot # T009743 and expiration date 27-JAN-2020. The patient believed this was his second dose, but could not confirm it.   On the same day of vaccination, the  patient experienced sore arm with swelling, the reporter stated that the swelling was not at the injection site, but it was near patient's biceps in the vaccinated arm. The swelling arm compare to the other patient's arm was about 1.5 the normal size. He sought for medical attention and none treatment was given.   The outcome of pain in extremity and peripheral swelling was reported as not recovered/not resolved.   The reporter did not assessed the causality relationship between the  pain in extremity and peripheral swelling with Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009743; expirationdate: 27-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: Yes; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
5/11/2021 - 4 am - woke up with slight headache and extreme nausea  5:30 am - vomited and had painful back pain that radiated down through hips and thighs (could not lay still or get comfortable), fever of 101.9, had chills, took 2 Tylenol  10:30 am - at 3/4 piece of toast and sipped on 7up, fever of 101.2, had chills 11:00 am - vomited up toast and sprite.  Headache was worse and made me dizzy.   12:00 pm - back, hips, and thighs were in pain and kept waking me up.  Sitting up was hard and headache worse 2:00 pm - vomited water and then turned into stomach acid and then dry heaved (capillaries around eyes were busted and I have spots) fever 100.8
Gastric problem; She felt fast heart beat; Felt hand pain; Hand soreness; Drowsiness; Slight body discomfort; Burning sensation in the chest area; Sleeplessness; Feeling that her hands are shaking sometimes; Tiredness; Weakness; This is a spontaneous report received from pfizer sponsered program Support. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 1 via an unspecified route of administration, administered in Deltoid Left on 25Jun2021(at the age of 39 years old) (Batch/Lot Number: EW0191) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications. On 26Jun2021 the patient experienced she felt burning sensation in the chest area and then, she had, the second day and then the third day after her dose, she also on 27Jun2021 felt hand pain, drowsiness and slight body discomfort. From the fourth day until the tenth day after her first dose there were no signs of any discomfort but on eleventh day after the first dose, she said, when she lay down on the bed, after sleeping, 15 to 20 minutes after, she felt fast heart beat for a few seconds and had trouble going back to sleep and then on the twelfth day until the day, she is still feeling tiredness and weakness and she thought that maybe it is because of gastric problem and due to sleeplessness (Gastric problem and sleeplessness captured as events as per verbatim since further clarification was unknown). Also, she is feeling that her hands are shaking sometimes. Consumer further stated, Is this only have information sharing Actually, I just wanted to know what is a further procedure like whether I have to go for second vaccination dose or before that what is my condition after taking first dose. So, all these details, I thought like to share but I don't know like only just I have given details, but I did not receive any kind of guidance from this. So, I don't know what are these number first or for what I have given these number, I don't understand because in the next week I have the second dose before that I would like to check whether I have to go for second dose because I am facing now, some weakness, tiredness and something like burning sensation kind of thing in my chest area. So, whether I have to go because only one week was left and I thought I would get some information on this, whom I have to contact or where I have to go to if any investigation required. Outcome of event chest pain not recovered, for pain in extremity, drowsiness, she felt fast heartbeat, tiredness, weakness, gastric problem, sleeplessness, feeling that her hands are shaking sometimes was unknown, slight body discomfort was recovered on unspecified date.  Information on Lot/Batch number was available. Additional information has been requested.
Per mom, child coughed at night, nonstop sounded like a "whoop" when taking a breath.
101 plus temp; heaviness in chest; difficulty breathing deeply; severe itchy rash/welts on torso, entire back, legs and arms; achy; lethargic; no appetite; This is a spontaneous report from a contactable consumer.   A 54-years-old not-pregnant female patient received (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 24Apr2021 at 11:00 AM (Batch/Lot number: unknown) (age at vaccination 54-years) as dose 1, single for covid-19 immunisation. The patient had possibly of penicillin allergy. Medical history included breast cancer from an unknown date to 2021 (breast cancer 5 years ago, currently recovered). The patient was not pregnant. The patient had not received any other vaccine within 4 weeks. Patient had not been tested post the vaccination. Concomitant medications included vitamin d nos (VITAMIN D NOS); biotin (BIOTIN) both taken for an unspecified indication, start and stop date were not reported and multi vitamin. The patient experienced 101 plus temp, heaviness in chest, difficulty breathing deeply, severe itchy rash/welts on torso, entire back, legs and arms, achy, lethargic, no appetite on 26 Apr2021 at 06:00 PM. Adverse event resulted in patient visited to Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature 101 plus temperature on 26Apr2021. The therapeutic measure was taken with steroid, inhaler. The outcome of all events was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Very achy and tired the following day. very tender at injection site for three days following injection.  Bruising at injection site.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender who on an unspecified dates were vaccinated with improperly stored doses of GARDASIL (dose, route, lot # and expiration date were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arm was sore the day of the vaccine. Next day felt tired, sore--but did not think it was out of norm.  On Friday started feeling bad, around 8am, patient noticed the redness on site; there was a red streak 3 inches long coming down from site, bicep completely red and had elevated temperature.  It was red enough that patient thought it looked like inflammation.    Patient called vaccine administrator and took Tylenol 650; patient felt better somewhat.   Patient went to doctor and specified it was not coming from vaccination site.  Doctor asked whether patient had low immune system and specified it was strep under the skin.  Doctor specified that it was not contagious and prescribed generic Augmentin. Patient felt better after taking antibiotic; it lasted for 5 days.   The redness slowly went away,   went to doctor on 10/30, because redness was still there and told that did not need more antibiotics. By yesterday patient felt better.   Today, only a little bit of redness remains.    Today patient not feeling great and not sure whether related vaccine or not.   Reaction to Flu vaccine in 2009 was similar but much worse; redness and warmth were similar but did not take any antibiotics.   Patient did not have carcinoma at the time but lung infection micro bacteria avian complex. Patient has received Flu vaccines after that year with no problems
Over a period of about 1.5 months, I developed hives all over my body. They started on my chest/upper back and slowly spread throughout. I had no idea what was wrong with me but knew I had reached a breaking point when all I could think about was the itching. I was scratching so much that I was causing deep bruising to form all over my body. Finally I was able to see a dermatologist on 5/3/21 who has started me on a Prednisone regimen and took a couple of skin biopsies while he was at it (still waiting for the results). Three days into treatment, this does seem to be helping.