chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states that she continues to have pain in her left arm after she received Tdap vaccine.  Patient also states that it is difficult for her to lift her arm past a certain point.  Received Tdap vaccine on 07/20/2015.
7/27/10 mother came to clinic to report that the day after child rec'd shots a rash over her body appeared & went away with the treatment of BENADRYL gel (on face, back, chest & legs). On July 24th (Sat.) child experienced stomach cramping & threw up after taking Pepto bismol. She is able to eat & keep food down.
11/20/21 presents to ED for "worsening dyspnea and cough". PMHx of "CAP, aflutter on Eliquis, CAD, cirrhosis s/p transplant COPD".
PATIENT TOLD HER MOTHER SHE WAS DIZZY AND WAS GOING TO PASS OUT. SHE PASSED OUT SECONDS LATER. SHE WAS OUT APPROXIMATELY 3 MINUTES AND "CAME TO". SHE WAS VERY THIRSTY AND STATED "IT IS VERY HOT IN HERE". TEMPERATURE ON THERMOSTAT WAS 72 DEGREES FAHRENHEIT. 911 WAS CALLED WHILE PATIENT WAS UNCONSCIOUS. EMT'S ARRIVED ABOUT 5 MINUTES AFTER THE CALL AND VITALS WERE TAKEN. BLOOD PRESSURE WAS FOUND TO BE 109/80. O2 WAS GOOD. MOTHER REFUSED ANY FURTHER MEDICAL ATTENTION. PATIENT WALKED OUT WITH MINIMAL ASSISTANCE.
Chills, body aches, fever, headache, diarrhea, swollen throat, heavy chest
After the normal fever symptoms the next two days after my second shot (limited nausea but lots of sinus pressure including a pretty bad tension headache at the beginning of the third day) concluded, I thought I was home free (the injection site is still a bit sore but now hardly noticeable, like a mild bruise). I had been consuming one ibuprofen every six hours starting immediately after my covid shot until mid way through the second day after. This evening, (around 10:00pm the third day after receiving the shot) I noticed a red rash had appeared on the front of the arm in which I had received my covid shot. It is red, hot to the touch, and stings when touched; it is an oblong shape approximately 4" in length, 1" wide at the bottom, and 3" wide at the top, ending about 2" above my elbow. So far all I've done about it is try not to touch it and put Aveeno Daily Moisturizing Lotion (fragrance free) on it. That seems to help with the burning, but when I stretch my arm up, the burning and slight stinging briefly intensify.
patient was inadvertently administered intramuscularly only the liquid (DTaP-IPV) component of the Pentacel vaccine, and not the lyophilized (Hib) component of the vaccine withno adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Medical Information (MI) (Reference number- 00694606) and transmitted to Sanofi on 23-Jul-2021.  This case involves a 2-month-old female patient who was "inadvertently administered intramuscularly only the liquid (dtap-ipv) component of the pentacel vaccine and not the lyophilized (hib) component of the vaccine" (product preparation issue) while receiving DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)].  The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 22-Jul-2021, the patient received a dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [lot UJ434ABA and expiry date: 08-Mar-2022] via an unknown route at an intramuscularly for prophylactic vaccination.  It was a case of actual medication error due to product preparation issue (Latency: on the same day).  It was reported that, "pharmacist did not have information on where on the body the vaccine was administered".   At time of reporting, the outcome was unknown for the event.  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 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.
Fever Headache,fever,and fatigue after 2nd Pfizer COVID vaccine causing loss of work. Narrative: Headache,fever,and fatigue after 2nd Pfizer COVID vaccine causing loss of work.
Sunday 10/17 frequent nocturnal urination, chills, headache, lethargy and mild fever lasting for 16 hours.
pt recv vax 20NOV95 & devel t100-101 which resolved;7 days p/vax devel low grade 99-100 fever that has not abated since that time;w/u performed thus far has been negative;pt c/o sore throat, bilat ofalgia, dec energy & coryza;had rash DEC
Patient experienced an ischemic stroke in the L frontal lobe 16 days after the 1st Moderna vaccine. It was considered significant. He has R side paralysis of the arm and leg.  The morning of the stroke he felt tingling on his R side of his body. He had full use of his R hand and leg for a few hours after the onset of the stroke however due to his allergy of contrast dye he was unable to get the MRI needed to confirm he was having a stroke and it was too many hours past the time to take the drug responsible for breaking up the clot (tPA). By the next morning the clot had caused more damage and he was completely paralyzed on the R side of his body.  He does have good cognition and speech however he feels like his mental capacity is diminished from what it was previously.  The stroke happened 10 months ago and he is ambulatory with weakness in the R leg and still no ability to use the R arm.  Patient was a healthy man despite his type 2 diabetes. He maintained a lower weight and was working with Dr. to control his blood sugars and was on Tresiba (insulin).  After the AE he had a CAC test done and was rated a 16/400. Dr. told him based on these scores patient wasn't at risk for a stroke.
on October 27, 2022 I received  phone notification from the police that the patient (my brother) passed away that morning.  He had been found, discolored and expired, by his live in female companion lying with blood coming from his mouth. Several days before she has told me he received both a covid booster and flue vaccine and had been feeling sick ever since, but didnt wish to see a doctor. His body has been sent directly to a funeral home where in now lies, never having been seen by any medical authority.   This is a stunning shock to me as right up to the event he was in perfect health and I had spoken to him by phone the previous week.  I should like to know the exact cause of his demise, but this is difficult as specific information about the vaccine and his medical records are private, and would be grateful if you investigate this further.
I have a reaction to the flu shot so my MD recommended that I premedicate with Zyrtec. I did one hour prior to injection. Around 5 minutes after my injection I could feel my throat swelling. I alerted the nurse and took a Benadryl tablet. The swelling stayed consistent and I was able to breathe so I waited for an hour and then went home. When I arrived home I felt and increase in the swelling so I took another Benadryl. The swelling slightly decreased but was still present for 5 hours post shot and then disappeared.  The only other reaction I had was metallic taste in my mouth and extremely sore arm where injection was given for 2 days.
Very bad pain in night, woke me up, from back of head aLL way down body but not Feet. Hurt too bad to arise and take medication so as Long as still, not too bad so went to sleep. Morning too bad to get up sot stayed still until 8AM. As Day went on-got better. ARM hurt for 2 wks were shot site was (oFF and on.)
I received a phone from patients husband stating patient was in the hospital with blood clots in her spinal cord and the part of the patients brain was dying and patient was in a coma. I called Hospital to get more information but they would not give me information they said it was HIPPA information
erythema multiforme since last noc 27APR98 pertussis rxn;tx pediapred x 5 days;
Swollen lymph nodes+ swelling- treated with prednisone  (this was patient's 3 rd booster shot- 2nd shot administered 4/24/2021)
COVID-19; COVID-19; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm 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's relevant medical history included: "Migraine" (unspecified if ongoing); "known allergies: Mango" (unspecified if ongoing), notes: known allergies mango. Concomitant medication(s) included: WELLBUTRIN, start date: 01Aug2020; AIMOVIG, start date: 01Dec2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 and patient was treated with Paxlovid from 16May2022 to 22May2022.  Clinical course includes Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 16May2022, Treatment stop date: 21May2022, Indication: Treatment of COVID-19, Adverse event: rebound on day 10. congestion, fatigue. Patient not recovered. No treatment for AE.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Started having nausea, vomiting, diarrhea, palpitations, myalgias, dizziness, fever of 100, arm heavy on 2/3/21. Had second COVID vaccine on 2/2/21. Went to Urgent care on 2/3/21 and diagnosed with Non-intractable vomiting and acute diarrhea.
Lack of efficacy, positive COVID19 test results with mild symptoms developing; Lack of efficacy, positive COVID19 test results with mild symptoms developing; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via intramuscular, administered in arm left on 22Feb2021 (Lot Number: EL3247) as dose 2, single, and received dose 1 via intramuscular, administered in arm left on 01Feb2021 (Lot Number: EL3247) (Age at Vaccination: 23 Years) as dose 1, single for covid-19 immunisation at Workplace clinic. The patient had no known allergies. Medical history was reported as none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications the patient received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient experienced lack of efficacy, positive covid19 test results with mild symptoms developing on 02Nov2021. The adverse events doesnot result to visit emergency room or physician office. The patient did not received any treatment for the events. The patient underwent lab tests and procedures which included Lumiradx sars-cov2 ag test: positive Nasal Swab on 03Nov2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
PT RECD 2ND DOSE PFIZER VACCINE ON 5/4/21, HAS BEEN HAVING SWOLLEN LYMPH NODES AND DIFFICULTY BREATHING WHICH CONITNUED FOR THE PAST 2 WEEKS. PT DID NOT SEE MEDICAL CARE, BUT RETURNED BACK TO OC FAIR POD TO RECEIVE MEDICAL CARE. PARAMEDICS ASSESSED PT, VSS, LUNGS CLEAR, WAS OFFERED TRANSPORT TO HOSPITAL BUT REFUSED. HE WILL GO TO HOSPITLA BY HIMSELF.
Patient started with facial flushing at about 5pm which progressed to swelling of the face and right lower eyelid and left ear, flushing of chest, patient began scratching.  NO RESP symptoms, patient was happy, laughing.
Covid Arm. My arm started itching 1 week after the first dose of the vaccine. The next day, there was a red lesion around the injection spot. By Friday evening, the lesion was mostly gone
24 y.o. female with no significant past medical history who was diagnosed with COVID-19 (NP PCR on 1/27/2021) with mild symptoms (3-4 days of rhinorrhea and myalgia) and complete recovery with return to work who recently completed COVID-19 vaccine series (Pfizer 1/8/2021, 2/5/2021) now presenting for hospitalization (2/26/2021) with fever, rapidly progressive hypoxia, and hyperinflammatory state including elevated ESR, CRP, ferritin, D-dimer, and troponin (20) in the setting of positive COVID-19 NP PCR (2/26/2021) and positive S.pneumoniae urine ag with clinical diagnosis of MIS-A s/p high dose methylprednisolone and IVIG.
On October 10, 2022 I experienced numbness and tingling on the left down my face and into my legs.  No medications were prescribed.
Lost her voice; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Lost her voice) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced APHONIA (Lost her voice). At the time of the report, APHONIA (Lost her voice) outcome was unknown.            Treatment medications included antibiotics. Concomitant product use was not provided by the reporter.
Symptoms continue from last 36 hours: fever, vomiting, chicken pox like rash, fatigue, loss of appetite. Administered infant Advil, lots of fluids and resting.
Extreme fatigue with accompanying dizziness and vertigo  beginning evening 2/11/2021. Awoke with severe vertigo following morning of 2-12/2021 and migraine.  No relief with OTC meds.  Still present with no improvement upon awakening morning of 2-13/2021
NOT SURE THIS IS EVEN AN OUTCOME OF THE VACCINE, BECAUSE I HAVE HAD THE HEAD COLD AT THE EXACT SAME TIME AS GETTING THE VACCINE ON JAN 31, 2020, BUT THOUGHT I SHOULD REPORT.    1.  HAD A VERY MINOR HEADACHE THE TWO DAYS FOLLOWING THE VACCINE, JUST MILD DISCOMFORT.  FULLY RESOLVED ON ITS OWN AFTER TWO DAYS.  2.  MONDAY, JANUARY 4 WHEN I WOKE UP I FELT "PUFFY" - FEET AND HANDS WERE MILDLY SWOLLEN.  NOTICED MY SHOES FELT TIGHTER THAN USUAL AND HANDS FELT A BIT DIFFICULT TO FULLY CLOSE.  THIS IS FLUID RETENTION, AS IF YOU HAD TOO MUCH SALTY FOOD THE DAY BEFORE, AND I THOUGHT PERHAPS I HAD INGESTED MORE SALT THAN I REALIZED ON SUNDAY.  BUT IT HAS BEEN YEARS SINCE THAT OCCURRED FOR ME AND MY DIET DOES NOT INCLUDE MUCH SALT OR PROCESSED FOODS.  THEN TODAY MY FEET AND HANDS STILL FEEL PUFFY, SHOES STILL A BIT TIGHT AND HANDS A BIT HARD TO CLOSE SO THERE IS STILL SOME FLUID RETENTION GOING ON.  THIS IS QUITE UNUSUAL FOR ME, I AM QUITE HEALTHY AND HAVE A GOOD DIET AND DON'T RECALL THIS HAPPENING BEFORE.    AGAIN, NOT AT ALL SURE THIS IS RELATED TO THE VACCINE, IT MAY HAVE SOMETHING TO DO WITH THE HEAD COLD, BUT AS I AM NOT SURE AND THIS IS UNUSUAL AND HAS OCCURRED AFTER RECEIVING THE VACCINE, I FELT I SHOULD REPORT IT.  THIS EFFECT IS VERY MILD AND I AM NOT CONCERNED ABOUT IT AND IT.
P92 BP172/98 121/85 Diaphoretic, dizzy, hot. EMS evaluated EKG done transfer  to ER 5:35
My daughter immediately was sore at the vaccine site, which by 3:30 was so bad she could not be touched on her legs at all.  She also developed a fever by the afternoon, over 101.  I gave her Tylenol, as directed by the doctor.  By 7:00 pm, she was screaming for hours and could not be consoled.  She vomited three times over night and would not sleep more than 20 minutes at a time all night.  She was not back to normal for days.
LITTLE BLOOD CLOT ON LEFT LEG NEAR KNEE THE SIZE OF PENNY; ARM SORENESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 26 year old female with unspecified ethnicity. 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, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 06-AUG-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-AUG-2021, the patient experienced arm soreness initially for 3 or 4 days at the injection site. On 25-AUG-2021, the patient experienced little blood clot on left leg near knee the size of a penny. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness at the injection site on 10-AUG-2021, and the outcome of little blood clot on left leg near knee the size of penny was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210851662- Covid-19 vaccine ad26.cov2.s- Little blood clot on left leg near knee the size of penny. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pain, swelling, tenderness R wrist developed over a 3-4 hour period, worsened for 8 hours. Was seen by orthopedics, x-rayed and seen by rheumatologist. Treated with steroids. Improved over 24-48 hours with no residue at that time. Since then almost monthly episodes involving wrists, hips and shoulders. Initiation of methotrexate 2 months ago without recurrence: palindromic rheumatism...
I got very I'll; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 28-Nov-2020.  This case involves a patient of an unknown demographics who got very ill (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got very ill (illness), (unknown latency) following the shot of INFLUENZA VACCINE. Further reported that quit taking them. No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 31-MAY-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX vaccine the patient developed skin sensitivity, a burning sensation throughout her torso, and feelings of numbness and tingling in her feet. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from shingles. Thereafter, the patient's feelings of numbness, weakness, and tingling in her extremities worsened in intensity and duration, and on 07-JAN-2017, the patient presented to another physician and was diagnosed as suffering from acute transverse myelitis. As a direct and proximate result of these malfunctions, 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. Upon internal review acute transverse myelitis was considered medically significant. Additional information has been requested.
This spontaneous report as received from a nurse regarding unspecified number of patients of unknown age. Concurrent conditions and medical history were reported. On an unknown dates, the unspecified number of patients were vaccinated with M-M-R II (dosage regimen, lot# and expiration date were not reported) that was stored improperly (inappropriate product storage). No adverse events were reported. No further information was provided. This case is one of several reports from the same reporter. Additional information has been requested.
6MAY92 sz, twitching, jerking, eyes rolled back, face turned blue; pt taken to hosp by ambulance; adm; md said was a sz; fever was 103+ then 7MAY92 PM 104.1;
When they heard she was on chemotherapy, they did not give it to her; losing her voice; This is a spontaneous report of a contactable consumer (patient). A 75-year-old patient received first dose of BNT162B2 (solution for injection; Batch/Lot Number: EN5310) via an unspecified route of administration in left arm on 27Feb2021 as single dose for covid-19 immunisation. Medical history included neoplasm malignant. Concomitant medications were not reported. The patient did not have any problem with the first dose of vaccine, the patient was having problem getting appointment for second shot, as she was on chemotherapy for treating the cancer, they did not give her second dose, the patient was panicking because she is a senior with high risk, and it was making her crazy that she cannot get second dose. It was unknown if reporter was a healthcare professional and prescribing HCP. Patient had her first dose of the Pfizer covid-19 vaccine on 27Feb2021 and had been trying to find a place for the second dose of Pfizer, patient stated her area only has Moderna right now, patient had already called the health department and doesn't know what to do, patient was a senior with cancer on chemo, clarified this was before first dose, patient stated she was also losing her voice, was tested 2 days ago for covid-19 and test was negative. The outcome of the events were unknown.  Follow-up (02Apr2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that: new event "losing her voice" added, dose description and narrative updated.  No follow up attempts are possible. No further information is expected
Developed pain in front, right of neck - thought it might be in trachea.  Later, pain spread to right shoulder and to right upper back and to right chest. Pain remained overnight and throughout the next day.  Took, one Advil.
Pain, tenderness, induration to injection site on left upper extremity. Left upper extremity also with intermittent numbness/tingling as well as slightly decreased range of motion due to discomfort.
Janssen COVID-19 Vaccine EUA Received vaccine at 11 am and at 8 pm I started to feel weak, achy, and feverish. 101 temp. Took Tylenol extra strength rapid release gel caps. Woke up at 11 pm with body aches, moderate/severe back pain, fever 101, nausea. Iced back and neck and called pharmacy at 1:30 am to see if I could take ibuprofen. Took 2 ibuprofen at 2am and that helped subside the back pain, body aches, and fever. Felt tired, achy, nauseous for the next 24 hrs.  Felt about 75% better 48 hours later, but still tired and off and on nausea. I also had a mild headache from day 1 - 3 and a dry cough that continues a week later.