chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 12-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided).This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
I donate blood regularly. After being vaccinated the second time, I got paperwork from the Facility that said they had tested my blood and found an elevated level of something indicating that I could have syphilis. The Facility banned me from donating saying that I had to go get a blood test proving that I am not infected. I visited my doctor, got a full blood workup which came back negative for syphilis. A couple of weeks later, the Facility sent a notice to me saying that they had trouble filtering my blood for the past several times and the reason is that I have cold agglutinin disease, which causes my blood to thicken when it cools. I have been a donor since high school and have never had either issue arise before now.
Started approximately 3/16/21 slight tightness in chest, fluttering in chest. Fluttering was most significant symptom, and got more frequent after started. Slight shortness of breath. Went to ER on 3/21/21 after almost passing out. Symptoms went away approximately 3/23/21.
reported "mild pain reaction at the site of my Moderna #2 on Friday morning" Patient still experiencing continued discomfort today 2/2/2021. She reports pain 3/10 on scale. She did not experience this on the primer dose.
Covid arm got 7 days after shot hot swelling red upper arm with rash,very itchy lasted eight days but still have tiny itchy spots on thighs,very few.
On 1/31, 4 days after vaccine she developed left-sided chest pain described as pressure  radiating to left arm.  In ED, troponin was elevated and she had emergent left heart catheterization.   LHC found normal coronaries and she was discharged home.
Grandmother called to notify me that child had a temperature 1 hour after getting today's vaccinations.  Grandma gave Tylenol at 11am and infant took a nap.  At 4pm, Grandma said child's temperature is 103.1 and had not received pain reliver since 11 am.    Encouraged to given Tylenol and Ibuprofen per bottle directions and give luke warm bath.  Is to contact physician office or ER number if fever gets higher.   Next day, grandma said pain reliver and bath helped bring fever "way" down.  No hospital visit.
woke up nauseous  2nd daylater drank some coffee I small cup took vitamins threw up kept feeling nauseous from Thursday until Tuesday . At first after vaccine I felt hot then cold no chills.
Patient received vaccine on 11/9/05 afternoon and states on the morning of 11/10/05 she experienced severe pain in the injection site of the L deltoid, radiating upward to the L shoulder and neck area, as well as radiating downward to the wrist area with numbing and tingling of the middle finger. Patient states the injection site, beneath the skin is 'lumpy.' Note - Patient reported adverse event to Health Department on 12/16/05.
Day after receiving vaccine I began having a twitch on the left side of my face beside my nose. It has lessened since it began, but is still present.
Upon waking at about 2 am in the morning, my left arm was partially paralized, pins and needs in my fingers. I went to go to the bathroom and blacked out on my way back to the bedroom and came too sitting on my file floor, very disoriented and my clothese wee drenched in cold sweat so much so that I needed to change. For the next 3 days I experienced fatigue, vertigo and brain fog. When I had COVID in April of 2020 and didn't experience any symptoms like this. After four days, I continued to have aches in my legs for another 5 days and my fatigue lifted gradually.
Within 3 minutes of receiving vaccine, associate became flushed, tachycardic, tingling to chest and abdomen, and weakness of legs.  She was observed for 35 minutes by Drs. during this time period.  Symptoms resolved in entirety during this time.  Associate was later contacted by Dr. via phone follow-up 1 hour after leaving vaccine clinic and associate reports symptoms continue to be resolved and did not reoccur.
cranky as soon as got home from getting 2nd series; fever that evening temp elevated 102-103 for next 8 days; had APAP 2 hrs prior to shots 7 cont; MD said probably virus; pt constantly cranky, irritable & not feeding well; rash noticed;
Patient came to the ED with chest congestion, mild cough, and shortness of breath.  Patient was admitted to the hospital for Covid pneumonia and treated with remdesivir.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-211432 (Patient Link).
Mild reaction on the LAT, area appears awollen, no pain showed to touch but felt a little warmth to touch, mother denies temperature, pt fussy just the night of the day vaccines were given.
pt recv vax DEC95 & MAY96 pt exp positive EBV titer;f/u recv from pharmacist which indicated did not remember any report of a 48 yr old recv hep B vax;
1326 patient in general observation area, states she is beginning to have a rash at the vaccine site in Lt. arm. Ambulated to Private observation area. Rash on left arm about 3 inch circumference. Has small red flat dots on chest. Denies itching or burning.  EMT in attendance 1327 - Gave two 25 mg tablet Benadryl by mouth. Swallowing water without difficulty. Denies throat involvement. O2 sat 99% on room air (r/a) HR 113, BP 132/87 1340 - Rash localized left arm, few red spots on chest, continues to deny throat involvement. States, "I know what anaphylaxis feels like and this is not it"  HR 104;O2 100% r/a 1354 - Cheeks, chin and neck have blotchy flat red rash. Denies throat involvement, denies itching/burning. Declined ice for comfort 1412 rash less red on left arm, has extended to face and neck area. Denies throat involvement. Denies itching/burning.  EMT advised patient to be transported to ER for evaluation by a physician. Patient refused and said she would seek medical car if symptoms worsened.  1414  HR 99; BP 129/81; RR 16 unlabored; O2 100% on r/a 1428 - Patient ambulated without difficulty to personal vehicle.
Injection site within 5 minutes turned red and started itching severely. Claritin 10mg was administered PO. Ice pack was administered topically. Within 15 minutes DX relieved.
Vaccine 9/22. 9/24/17 Started having congestion, loose cough. Unsteadiness with walking. Was seen in ER 9/29/17 with ear infection. 10/31/17 Back to ER, imbalanced unsteady gait, dizzy, seemed confused. 11/1/17 CT Scan of head-nl result. Discharged 11/2/17 symptoms improving. 11/6/17 Follow up visit-cont. to improve. Follow up scheduled 11/14/17.
9/13/06 In to health center for vaccines.  9/18/06 call from pt's mother-c/o nickel size blisters down side of neck.  Toook to ER and mom reported child dx with shingles due to immune response from vaccines.
Localized red/warm/hard area at inj site (L) leg. No fever. 2" in diameter.
One week after shots given, multiple (>50) red, round, pruritic plaques ranging from 1 cm - 6 cm some w/ central clearing on trunk, neck, arms, legs, groin, sparing palms/soles errupted.  No other history of URI symtpoms nor allergenic exposure given.  Treated with triaminolone 0.1% ointment and hydroxyzine 12.5 mg q 6 hours started the day form completed.  Lesions look like hives vs. erythema multiforme.
Red, hot swollen hands, knees and feet in all weather Finger joint stiffness/synovitis White and blue blanching numb/painful fingers in cold weather Feeling like I'm on fire on the inside Debilitating fatigue Extreme brain fog All over pain/deep muscle aches Feeling feverish
Mom called health department  at 1130am on 2/13/2020 and reported that patient was "broke out with a rash around his mouth and in his private area".  She is unsure of the time but stated she first noticed it "last night" and that he "acts like it itches" so she put "diaper rash cream on it and it made it some better". She was concerned that it was his immunizations received yesterday. RN asked if he was having any trouble breathing, eating or drinking and she reported "no".  Provider consulted,  and recommended that child be given "allergy medication, Benadryl or Zyrtec" and to follow instructions on label.  RN also educated Mom on monitoring for anaphylaxis and to call 911 if he was having any trouble breathing or swallowing. During phone call Mom additionally reported that now she see that the "rash is all over his body".
Information has been received from a nurse referring to unspecified patients of unknown age and gender. On 27-APR-2015 the patients were vaccinated with improperly stored (Merck) PROQUAD (lot # K022448, 13-MAY-2016)(dose and route unspecified). This is one of several reports from the same source. Additional information has been requested.
Information has been received from a nurse referring to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 29-AUG-2017, the patient was vaccinated with a dose of improperly stored PROQUAD (dose and frequency were unknown; lot # N008826 with expiration date 12-SEP-2018) subcutaneously for prophylaxis, which was exposed to temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 114 hours. There were no previous temperature excursions. DILUENT was stored properly. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008515.
Patient fainted after receiving the vaccine. BP 95/75HR 100, O2Sat100%. PAtient was transferred to stretcher   BP 106/65, HR 79, O2Sat 100% CAT team was called Patient was transferred to ED
Pt received Moderna vaccines on 01/11/2021 and 02/08/2021. Pt presented to the ED from an assisted living facility on 10/31/21 with complaints of cough, fever, and SOB. Pt's oxygen saturation was found to be at 88% and pt was placed on 4L nasal cannula. CXR was consistent with COVID pneumonia. On 11/12/21 pt was placed on hospice services. Pt expired on 11/13/2021
Blood has thickened, blood was viscous/ Not able to get a single full drop of blood; This spontaneous case was reported by a consumer and describes the occurrence of HYPERCOAGULATION (Blood has thickened, blood was viscous/ Not able to get a single full drop of blood) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.   No relevant Medical history Reported.  Concomitant products included LEVOTHYROXINE from 01-Apr-2021 to an unknown date for Hypothyroidism.  On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021 at 6:00 PM, the patient experienced HYPERCOAGULATION (Blood has thickened, blood was viscous/ Not able to get a single full drop of blood). At the time of the report, HYPERCOAGULATION (Blood has thickened, blood was viscous/ Not able to get a single full drop of blood) had not resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: (normal) Normal.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment medications were unknown.  The patient received three sporadic home blood tests as part of the study. She had always gotten several drops of blood right after accidentally pricking herself. Coincidentally, She had done one of the home tests, which require 5 full drops of blood, a couple of weeks before my first Moderna vaccine. She used the first of the two lancets provided and easily got the five full drops of blood without any effort. On 06-Apr-2021 and for the next three days, she tried getting blood from different fingers and using tips (warm water, rubbing hands, etc.) and was not able to get a single full drop of blood. A tiny bit would come out and immediately after, nothing else, even pressing or squeezing. She had to go to a lab and they draw blood to be able to complete the test. She hesitated taking the second dose and requested my doctor to order a thickness test before deciding. The test came back normal and although not entirely convinced.   This case was linked to MOD-2021-162995 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information was received on 24-May-2021 contains information regarding reporter address, the patient demographics, site of vaccine administration, details of concomitant medication (start date and indication), event start date, and the outcome of the event blood thickened.
Miscarriage. Notified of nonviable pregnancy on 10/22/2013. Actual miscarriage on 11/02/2013.
She had a 4 minutes seizure. All her body trembing and shaking. She started having seizures every 8-10 days. She was diagnosed with epilepsy. The seizures became more frequent after second round of vaccines (sometimes almost every day). Doctors never found the right medications for her. We were never able to control her epilepsy.
Rash below injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 18Mar2021 (13 days after shot), the patient experienced rash below injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event rash below injection site. The clinical outcome of rash below injection site was resolved in Mar2021.  No follow-up attempts are needed. No further information is expected.
pt recv vax 7/19/90 & 7/9/97 lab tests revealed rubella virus IgG antibody 0.86, indicating no rubella IgG antibodies detected;
Numbness and weakness and itching in left arm where vaccine given - started 3-4 days after getting vaccinated.
Patient presented to hospital with chief complaint of left shoulder pain. Over the past three days before ED admission, patient noted an increased amount of pain along with neck pain that is chronic. Back pain was noted as well. At time of ED admission, patient was on vancomycin treatment for C. Difficile-- slowly improving. her first high-sensitivity troponin was noted to be elevated at 124 with repeat at 144 one hour later. Patient was transferred to hospital for further work-up. Upon presentation at hospital admission, patient had worsening of left arm pain. EKG at that time showing ST elevation in the anterior leads and she was given nitroglycerin with improvement of pain. Case was discussed with cardiology on-call and the Cath Lab was activated for ST elevated myocardial infarction. Patient underwent left heart catheterization on the nigh of 12/31/2022 with noted 90% stenosis of the left anterior descending artery. Two 3.5 Xience stents were placed with return of TIMI-3 flow postintervention. ST elevated myocardial infarction of the left anterior descending artery status post drug-eluting stent. Left heart catheterization with drug-eluting stent placed in the LAD. Other coronary arteries without significant blockages. The patient was started on Plavix along with statin  therapy and was transferred back to the floor. Patient was monitored in the hospital until 1/2 without significant arrhythmias or recurrence of her pain. She tolerated medication adjustments without issues. She was deemed not appropriate candidate for ACE/ARB due to her renal transplant status and concern for renal function. Additionally she could not tolerate beta-blocker therapy due to low blood pressures. She did tolerate statin therapy. She is not placed on aspirin due to both Coumadin and now Plavix therapy. Ultrasound was obtained of the right groin prior to discharge due to some discomfort in that area but there was no evidence of pseudoaneurysm for catheter insertion site. Patient was deemed medically stable for discharge on 1/2/2023. The patient was discharged to home 1/2/2023 and has been referred to cardiology along with cardiac rehab. She is asked to maintain on warfarin along with Plavix. Plavix should continue for 1 year. She does not require aspirin at this time. Lipitor has been started in the setting of myocardial infarction. Patient was vaccinated with Janssen Ad26.CoV2.S Vaccine on 10/04/2022. As of 1/2/2023, the patient is 90 days out from their Janssen Ad26.C0V2.S vaccine. Per MD, this event is unrelated to the Janssen Ad26.CoV2.S vaccine administered on 10/04/2022 and is not related to any known side effects of the vaccine.
Individual received initial dose of Moderna on 3/24/21 and a second dose of Moderna on 4/9/21. Patient was informed. No immediate adverse events.
Day after shot felt likes bugs biting my back.  Next day huge red itchy bumps around waist and a few on my mid back.
Don't know if this is from my vaccine or not, but the person who called me about my latest survey update told me to report it just in case. Since early May I've been having muscle soreness in my wrists. Like a pulled tendon. Sometimes the pain is very bad if I try to lift heavy onjects over 10 pounds. This sometimes extends to the backs of my hands and knuckles. I've only recenty had a doctor look at my wrists, and they think it is strained and needs a brace for a while to see if it gets better (x-rqays ruled out bone issues).  I also had a major dental issue in April. I had a large abscess grow that wasn't there 6 months before (previous x-ray reviewed). The abcess required two root canals and a biopsy of the jaw bone (found nothing but normal infection). Dentist theorized that my body was so focused on fighting the vaccine and developing antibodies for COVID-19, that it didn't have the resources to fight off the infection.
This is a spontaneous report received from a contactable physician (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number EW0169), via unspecified route of administration in left arm on 29Apr2021 05:00 PM (at the age of 36-year-old) as 2nd dose, single for COVID-19 immunisation. The patient had no medical history. Prior to vaccination the patient was not diagnosed with COVID-19. No concomitant medications were reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number EW0150), via unspecified route of administration in left arm on 05Apr2021 04:00 PM (at the age of 36-year-old) as 1st dose, single for COVID-19 immunisation. On 30Apr2021 09:00 the patient experienced encephalopathy, vertigo, dizziness, fever, chills, nausea, myalgia, fatigue, cold sweats, headache, neck pain, injection site pain. The reporter stated that he was a doctor, he treated himself symptomatically. Patient had not been tested for COVID-19 since the vaccination. The outcome of the events was resolved with sequel.; Sender's Comments: The etiology for the reported event could be multifactorial however.Based on a temporal association  a causal relationship between the reported event and suspect drug is assessed as possible. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
RECEIVED ZOSTER VAC ON WEDNESDAY THE 28TH OF NOV.  ON SAT. DEC 1ST SHE DEVELOPED PAINFUL, LESION ON HER SCALP.  HAS NEW LESIONS TO SCALP AND NEW LESION TO HER LEFT EYE LID. NO VISION CHANGES.  TREATED WITH VALTREX.  REFER TO OPTHAMOLOGY FOR EYE LESION SAME DAY AS EXAM.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 at 12:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05May2021 at 13:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Nov2021 at 16:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Rebound. Symptoms reoccurred after treatment and were worse than original symptoms. Still had symptoms on day 14 and testing strongly positive. Rebound symptoms after Paxlovid started on 26Jul2022 9:00 AM leading to Prolongation of existing hospitalization (treatment received during existing hospitalization).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
Temperature of 104F, rash to body and fussy. Treated with Tylenol.