chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: (unspecified date) Positive, notes: tested positive again; (29May2022) Negative, notes: Completed 5 days of Paxlovid. Had a negative test; (03Jun2022) Positive, notes: started having symptoms again and tested positive again. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient had no known allergies. The patient had no other medical history. The patient's COVID got rebound while the patient was on unspecified Anti Viral details: Product covid-19 Treatment (Lot number: GA2279) for COVID-19 from 25May2022 to 29May2022. Other medication in 2 weeks product: Tylenol from 25May2022 to 26May2022. Completed 5 days of Paxlovid. Had a negative test. 5 day later, he started having symptoms again and tested positive again.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Immediately became pale and fainted - revived in at 15 seconds but couldn't remember what happened.
Got the shot and got shingles/Suspected vaccination failure; Got shingles, got them worse; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 08-FEB-2023 Reporter comment: This case was reported by a patient via interactive digital media. The patient received the Shingles shot and got shingles after and stated them as worse. The reporter thought that the event might had been related to the drug. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
I had a sudden onset of a loud pitch sound in my R ear that woke me up then it was intermittent but after getting the 2nd dose it is almost constant. I have seen by ENT 3x and had hearing test done 2x. Hearing showed mild hearing loss that I was already aware of as self discovered 2 years ago. Can only sleep because I started back taking prozac 40mg, and clonazepam 1mg at bedtime. Xanax 1mg taken during the day to help me relax. These are Rx'd.
a four months old baby was vaccinated bynurse using a wrong diluent for Pentacel, no AE.; Initial information received on 31-Dec-2019 regarding an unsolicited valid non-serious case from a Nurse.  This case involves a four months old patient who was vaccinated using a wrong diluent for DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ020AA and expiration date 09-Oct-2020)(PT: product preparation error) via unknown route in unknown administration site on an unknown date.   The medical history and concomitant medications were not reported.  It was an actual medication error case due to product preparation error. It was reported that the nurse did not use the diluent for Pentacel and used the diluent for Merck live vaccine- as reported.   No adverse event reported at the time of reporting.  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 and Module VI of the 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.
nurse was gave pt vax & pt moved & nurse got some of the vax in eyes &  on skin; nurse stated that eyes stung a bit;no further details were provided;
Soreness under armpit on injection site side. This has been listed as a side effect but it has not subsided. After the second vaccine both armpits are tender and feel swollen. It is intermittent but at times quite painful. I feel dizzy at times especially upon waking up. I also see floaters in my right eye. This is also intermittent.  I honestly have not felt quite right since receiving the vaccines. My complaints are the armpit swelling and tenderness, dizziness, and the floaters. Both symptoms are intermittent but I felt should be recorded somewhere. I am recording that my symptoms have not recovered because they continue to persist.
Possible discomfort in leg where shot was administered.  Stopped standing and crawling.  Very lethargic and would not move over long distances.  Fever up to 101.5  Decrease in appetite.  Symptoms lasted 7 days before they began to subside.
poss lipoma; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 01Oct2021 and 06Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer or other non HCP (patient). A 59-year-old female patient received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 2 intramuscularly, administered in Arm Right on 10Feb2021 at 12:00 (Batch/Lot Number: EM9809) as DOSE 2, SINGLE (at the age of 59-year-old) for covid-19 immunisation. The patient medical history and concomitant medications was none. Prior vaccination reported as none. Historical vaccine included first dose of bnt162b2 on 20Jan2021 at 12.00 (anatomical site of injection: Left Upper Arm (Below deltoid), Batch/Lot number: EL1283) (at the age of 59-year-old) for covid-19 immunisation. The patient experienced poss lipoma on 10Feb2021 at 14:00. The event caused physician office visit. The patient underwent lab tests and procedures which included Visual Inspection (by dermatologist) showed poss lipoma on an unknown date 2021. The event needed surgical removal. Therapeutic measures were taken as a result of event. The outcome event reported as not recovered.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
DAY ONE:  I had a general unwell feeling. I felt bad enough I closed my business early and went home. Developed mild fever and chills. My skin started crawling up the back of my neck and across my scalp. Slept poorly wasn't able to find a comfortable position. DAY TWO: I  could barely move my arm the pain was intense. When it was time to start my day I wasn't able to sit up in bed. I simply couldn't pull myself up into a sitting position. I was able to slide to the floor, crawl and pull myself up using a grounded piece of furniture.  didn't feel mentally competent enough to drive my car to work, much less work.  Equilibrium issues, I walked into furniture, walls and doors  Difficulty standing & walking Extreme pain in both big toes, ankles, knees & hips. Still had temperature, chills and crawling skin. Slept poorly DAY THREE: I slept most of Sunday. I didn't open my business. Sunday is my busiest day. I simply didn't care. Malaise. My left deltoid developed a huge lump on it and it became hot. All of the other symptoms still existed. DAY FOUR: My brain finally seemed connected to my body, so I went to take care of my clients, but came home  at 3 p.m.and slept until Tuesday morning. DAY FIVE: I still don't feel normal, but took care of my clients. Came home and slept. The swelling has moved down about 5 inches below the injection site and has begun to itch  I felt my brain was in a fog , I couldn't think - and I just couldn't do anything at all, but sit (so I wouldn't hurt myself) or sleep.
Pt states that injection arm is painful and hard to move. Also states she started ibuprofen and a pain patch that she already had at home.
Patient states that a couple days after the shot she started experiencing severe itching. She doesn't have hives or a rash present, but itchiness is exacerbated by physically itching skin. Patient took Benadryl which seems to help. Her chief complaint is that the itching has kept her up at night and is quite bothersome. This problem did lead to her being seen in the clinic by a physician.
Rash all throughout the body; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 15:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nuts, family history of malignant hypothermia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Mar2021 at 03:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021, the patient experienced rash all throughout the body. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash all throughout the body was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received vaccines fall of 2021, contracted COVID early 2022 and developed postural orthostatic tachycardia syndrome. Chest pressure, palpitations, tachycardia
9-20-17 CAME BY PHARMACY AND REPORTED THAT THE WHOLE ARM THE SHOT WAS ADMINISTERED IN IS  SORE. SHE REPORTS THAT SHE IS UNABLE TO USE THE ARM TO DRIVE. SHE ALSO STATES THAT HER PROTIME WAS 6.5 AND THAT IT IS USUALLY AROUND 2.
Initial information has been received from a registered nurse concerning her 5 year old daughter who on 27-AUG-2008 was vaccinated with a dose of VARIVAX (Merck) in the right arm (lot number 660568/0507X) (injection route not reported) and a dose of DTaP (manufacturer unknown) in the right arm, a dose of MMR II (MSD) in the left arm and a dose of poliovirus vaccine (manufacturer unknown) in the left arm. On 27-AUG-2008 night, the patient had a slight fever. On 28-AUG-2008, also reported as the following day, the patient developed severe swelling (approximately 3 x size of her left arm) of her right arm. The patient's right arm also became hot and red. The reporter noted that it "looked like cellulitis". The swelling, redness and warmth extended from the top of the patient's shoulder to her elbow. The patient was seen in the physician's office on 28-AUG-2008 and was treated with BENADRYL and TYLENOL. It was also reported that the patient had no adverse events following prior vaccination (she previously had all routine vaccinations). The patient's mother was going to monitor the patient's arm. If the patient did not improve she planned on taking her to the emergency room. Follow-up information was received from the registered nurse also the patient's mother which reported that the patient's symptoms had improved significantly on 31-AUG-2008. The patient went for a follow-up appointment on 02-SEP-2008 with the physician. According to the patient's mother, the physician thought that this was not an adverse reaction to vaccine, but a possible error in technique with the administration of IM injection of DTaP or the patient moved during administration. The patient's mother indicated that the physician stated that he thought it was a collection of blood due to this that caused the events. The physician also told the patient's mother that he did not agree that the patient shouldn't receive vaccine in the future. The patient's mother did not have lot number available but she still requested a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. Additional information has been requested.
Reports progressive shoulder pain, numbness and discoloration of L 2nd toe and L external ear. He report loss of memory on two occasions since vaccine administration and 2 episodes of aggressive behavior that are unusual for him.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949993 and 20210949906.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On unknown date, the patient was vaccinated with M-M-R II lot # L005291, albumin status: rHA, expiry date 17-FEB-2017 (route of administration, dose and dose number were not reported). The administered vaccine was improperly stored at temperature 56 Fahrenheit degrees, for 2 hours, (no data logger was involved). There was no previous temperature excursion. No adverse effects were reported. The physician reported that the temperature excursion occurred on 29-NOV-2016 due to a power outage. Albumin status for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live has been verified as recombinant human albumin (rHA). This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA007916: US-009507513-1612USA006317: US-009507513-1703USA000616:
Later on that night of receiving the vaccine I felt fatigued and had blurred vision. The next day in the morning I tried to go to work, but I had to leave because the blurred vision got worse. I was uncoordinated, had weakness, was excessively sleepy, had confusion, and had trouble of cognition.
Patient had 1st dose of Pfizer vaccine on 11/12/2021 and the last dose on 12/03/2021. Since then, patient has tested positive for COVID-19 twice (once on 12/29/2021 and on 01/28/2022). Patient thinks the vaccine doesn't work or something is wrong with it.
Rash that started last night. Has about 3 large spots on abdomen size of quarter and starting to form blisters in the center. No fevers. Areas red and itchy. Received immunizations on Monday. Also has 7 spots that are red on abdomen without blisters. No breathing difficulties or wheezing. No bluishness to skin. Is acting hungry but not wanting to eat. Patient has a papular rash in patches on her abdomen and under both armpits. 1-2 lesions on her upper back. Surrounding erythema.  They all appear at the same stage. No scabbing of lesions. Mom said is just not acting her normal self.
This spontaneous report was received from a Medical Assistant referring to a 26 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. In March 2007, the patient was vaccinated with the 1st dose of GARDASIL (anatomical route of vaccination, lot number and expiration date were not provided). Furthermore, in July 2007, she was vaccinated with the 2nd dose and in November 2007 with the 3rd dose of GARDASIL. In 2015, during the patient's annual physical examination, her Papanicolaou smear results were abnormal. At the time of the report, the outcome of smear cervix abnormal was unknown. The relatedness between the adverse event and vaccination with GARDASIL was not provided. Additional information has been requested.
Elevated Blood Pressure 4 hrs after injection: 158/93. After 24 hours blood pressure returned to normal 124/71
Received the J&J COVID-19 vaccine on 8/12/2021 and began to develop progressive weakness of the bilateral upper and lower extremities beginning the following day, reportedly spreading from distal arms proximally and then to the bilateral quadriceps over a few weeks, also associated with numbness and paresthesias of the distal extremities. Had evaluation including EMG/NCS and CSF studies that were compatible with acute inflammatory demyelinating polyneuropathy. s/p two admissions in 10/2021 and earlier in 12/2021 for a 5 day course of IVIg both times. During this current presentation due to subacute worsening of symptoms again, initially received a dose of IVIg in the ED before being transferred for initiation of plasma exchange.
Experienced persisting intermittent heart palpitations sustained leading to vagal maneuvers on two occassions and increase in atenolol dosage. Now saw cardiologist who has ordered halter monitor and lab work
Patient had a seizure shortly after receiving vaccines.  Patient had been very anxious prior to receiving her vaccines.  The patient had a seizure and was placed on the floor on her side.  EMS was called, vitals obtained, patient monitored.  Patient transported by local EMS to local hospital.  Guardian said "It's not the vaccines, she has a seizure disorder".
INPATIENT PHYSICAL THERAPY DAILY NOTE ==============================================================    ASSESSMENT: 67 year old male with COVID admitted for bacteremia, UTI and endocarditis. Patient was discharged from hospital on 9/5/23. He has thoracic vertebral fracture and has a TLSO for comfort when out of bed.  Patient requiring moderate assistance for bed mobility and was able to stand and take several steps using assistive device. Patient is limited by weakness in bilateral lower extremities, and decreased functional activity tolerance. He is below baseline and will benefit from additional therapy during hospital stay and daily therapy once discharged.  Request for OT evaluation. DISCHARGE RECOMMENDATIONS: Daily Physical Therapy   CAREGIVER TRAINING REQUIRED?: No, so long as patient   pt in house bed
Post 3 days of vaccine, patient has a 61mm in circular pinkish induration area at vaccine injection site of right arm, tender on palpation burning sensation.  Better today than last 2 days.  Overall patient denies any other symptoms.
This spontaneous report was received from a medical assistant and refers to a 10 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 09-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Since vaccination yesterday, she has a headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Since vaccination yesterday, she has a headache) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031278) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 01-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced HEADACHE (Since vaccination yesterday, she has a headache). At the time of the report, HEADACHE (Since vaccination yesterday, she has a headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient queried that if patient could take treatment medication Tylenol after vaccination.   Reporter did not allow further contact
Began as typical arm pain after shot.  Has continued as pain around injection site and sometimes traveling into neck on shot side.  Pain is primarily experienced when pressure is applied but can occur just in movement.
cannot move arm without having pain; Blotchy Skin Injection Site 2" across; Red Injection Site 2" across; A spontaneous report was received from a 41-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and cannot move arm with out having pain , injection site on arm is red and blotchy about 2" across.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 10 Jan 2021, at 2pm, the patient received his first of two planned doses of mRNA-1273 (Lot: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Jan 2021, since administration, the patient can not move his arm without having pain. He stated, when he takes ibuprofen, movement is possible and better. He also mentioned his injection site on the arm is red and blotchy about 2" across. He stated that his sister, who is an emergency room physician, suggested he take diphenhydramine hydrochloride and use a warm compress.   The outcome of the events, cannot move arm without having pain, injection site on arm is red and blotchy about 2" across, were unknown.; 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.