chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He received zostavax vaccine and tetanus-diphtheria (Td) on 5-12-08. Several hours later he noted itchy rash. Was seen in clinic today for evaluation. The rash is dermatographism on upper chest, upper back, lower legs. No prior history of this. Otherwise well. Dr. and myself (reporter) work in our allergy dept. and feel this is NOT a true allergic reaction, but wanted to report this. Treating with antihistamines and observation. We expect full recovery.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 10/12/2022 Discharge Date: Oct 19, 2022  HOSPITAL COURSE: Patient is an 86-year-old man with complex medical history who presented to our institution with weakness, falls and confusion.  He was recently diagnosed with COVID-19 on 10/08/2022.  His family is having an increasingly difficult time caring for him.  He was found on the ground after sliding off the chair.  He is noted to have decreased appetite as well as diarrhea and shortness of breath.  As an outpatient he was treated with molnupiravir however continue to worsen.   Upon arrival to emergency department, he was identified to have fever and leukocytosis, chest x-ray showed some pulmonary vascular congestion with bibasilar atelectasis.  He is felt to have sepsis syndrome, and this was felt to be predominantly related to COVID-19.  Is also found to have acute kidney injury with creatinine of 1.99.  As well as concern for acute on chronic systolic congestive Heart failure, he received 40 mg of IV Lasix in the emergency department and is admitted to the internal medicine service for further workup and management.   Patient initially showed no hypoxemia, however developed hypoxemia during hospitalization, at which time is initiated on dexamethasone and remdesivir.  He is found have a significant elevation of CRP at 300. He underwent CT imaging with findings of multifocal pneumonia consistent with COVID-19.  He had a rising white blood cell count with elevated procalcitonin, as well as a high risk for aspiration, therefore he was empirically started on Rocephin and doxycycline to complete a 5 day course.  Patient's respiratory status began to improve, and oxygen was weaned.  At discharge patient was maintaining normal O2 sats on room air.   He will complete total of 10 days of dexamethasone therapy.   In regards to the patient's toxic metabolic encephalopathy which was present on admission secondary to COVID-19 pneumonia, this resolved, patient is back to his mental status baseline.   Patient was weak from his recent infection, he was seen by PT and OT and subacute rehabilitation was recommended.   Patient has acute kidney injury resolved.  Discharge creatinine 1.8, which was consistent with his previous baseline creatinine.
Mother reports right arm from shoulder to elbow was double in size, red and itchy. Brought to MD by child's father.
Imm @ 6PM; no fever; no sxs; sz 845; ER; chill-turned blue-fever by time arrived @ ER; fever 105 R @ hosp; fever 102 R when left hosp;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2022 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID, start date: Apr2005; ESTRADOT, start date: Apr2007. Past drug history included: Minocycline, reaction(s): "known allergies: Minocycline", notes: known allergies: Minocycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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 lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded. While the vaccine cannot provide full protection with only 1 dose, further clinical and diagnostic information is needed for meaningful medical assessment.
Non stop crying which was uncontrollable. Agitated, arching back, will not sleep. All of which have continued and have not lessened even at 6 months of age. Child still screams 90% of the time, will not sleep. Bowel movements have changed and are not normal.
Excessive sleep in absence of somnolence. 14-16 hours/day. Change from baseline 8-10 hours.
Pt developed a generalized macular-papular blanching 1mm rash on trunk, extremities and face.
No additional adverse effect reported.; Caller reported that VARlVAX that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 05-FEB-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme frequency, route of administration, lot number T010313, which has been verified to be valid, expiration date reported and validated as 24-MAR-2022), that underwent a temperature excursion (product storage error). The vaccine administered experienced a temperature excursion of -10 degrees Celsius (C) (-6.7 C), for a time frame of 9 hours and 12 minutes and 0 seconds, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse events were reported.
Period issues/pain. Had recently been treated for endometriosis pain in Feb 2021 started on Orilissa and was having great results no pain no period then got 2nd CoVID shot and pain heavy periods came back.
All day in bed; All night long throwing up and it was coming from the other end too; All night long throwing up and it was coming from the other end too/ Threw up 25 times; Hot and cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), BEDRIDDEN (All day in bed), DIARRHOEA (All night long throwing up and it was coming from the other end too) and VOMITING (All night long throwing up and it was coming from the other end too/ Threw up 25 times) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 026P21A) for COVID-19 vaccination.     No medical history was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), DIARRHOEA (All night long throwing up and it was coming from the other end too) and VOMITING (All night long throwing up and it was coming from the other end too/ Threw up 25 times). On 04-Aug-2021, the patient experienced BEDRIDDEN (All day in bed). On 05-Aug-2021, BEDRIDDEN (All day in bed) had resolved. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), DIARRHOEA (All night long throwing up and it was coming from the other end too) and VOMITING (All night long throwing up and it was coming from the other end too/ Threw up 25 times) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included cancer, heart medicine and 13 medicines every morning. No treatment drug was reported.  The patient went home after vaccination and felt hot and cold. After supper time, went to bed but that night was all night long throwing up and it was coming from the other end too.   On Thursday patient was also in bed.  On 03-Sep-2021, Friday, the patient was feeling a little bit better.
decreased blood glucose levels; This case was reported by a consumer via call center representative and described the occurrence of blood glucose decreased in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included insulin nos (Insulin).   On 13th September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced blood glucose decreased. On an unknown date, the outcome of the blood glucose decreased was not recovered/not resolved.   It was unknown if the reporter considered the blood glucose decreased to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's wife. The patient received Shingrix on left arm. Since receiving the vaccine, the patient's blood glucose levels had been lower than normal. The caller stated that the patient had not needed his normal doses of insulin since receiving the vaccine.  The reporter consented to follow up.
March 15, Dose One No problem April 5, Dose Two 10 hours after had brain splitting headaches, chills, fever, sweats, nausea for 36 hours 48 hours later developed a big rash all across chest, sides, and back (taking Benadryl)
began feeling soreness like a punch in the arm progressing to barely able to lift arm. Disturbed my sleep for two nites. Soreness remained and daily gained the ability to raise my arm.  Rash on forearms worse on right than left. They were itchy/burning slightly reb bumps that tore easily and lite bleeding from rubbing. The pain/stiffness went deeper into the elbow feeling thick and dead like with pain at certain twists of movement. I still had muscular strength for a pushup or two but noticed tenderness/weakness in right elbow. Rash remains today applying Neosporin and or lotions.
My arm was sore a couple hours after vaccine. The next day, I was tired and my arm (right) was sore. No fever or anything. Sunday,  the 2nd, I had headaches and it came on and it was painful. It is always in my sinus area - above the bridge of my nose and forehead. They have been coming every day in the afternoon and it stays until I go to bed unless I take a medicine - if I take medicine it's a 2 out of 10 instead of 6 out of ten for pain. My doctor put me on Steroids before second dose . That helped get rid of the headaches for the five day course but after the course of steroids I got them every day again.  I had about two or three doctor visits after that first visit - at least 2 in person and one or two telehealth. And now after the second dose, she has referred me to specialist. I got the second dose on January 29th.  I saw an ENT - in February for this and he said I have some congestion but nothing crazy.
SHOT ADMINITERED AT APPROX 12:20PM.  PT STARTED HAVING RASH - ITCHING ON LEFT ARM AND RIGHT HAND MINUTES AFTER SHOT- AT THAT POINT (ROUGHLY 12:23PM), WE GAVE PT DIPHENDYDRAMINE 50MG FROM EMERGENCY KIT B/C SHE DID STATE THIS CAN HAPPEN WHEN SHE TAKES IBUPROFEN. DIPHENHYDRAMINE WAS GIVEN UPON PT AUTHORIZATION.  PT STATES SHE HAS TAKEN BEFORE.  PT DID NOT HAVE ANY BREATHING ISSUES OR FACIAL/THROAT INVOLVEMENT ENTIRE TIME AT PHARMACY- ONLY RASH/ITCHING AS STATED ABOVE. I DID LET PT KNOW THERE WAS AN URGENT CARE NEAR BY BUT SHE WAS NOT INTERESTING IN GOING. I OFFERED TO CALL PT PCP BUT SHE ALSO SAID SHE WAS NOT INTERSTING IN THAT EITHER.  I CHECKED ON PT MULTIPLE TIMES WITHIN 30 MINUTE TIMEFRAME AND SYMPTOMS DID NOT PROGESS.  WE DID HAVE PT STAY AT PHARMACY FOR ATLEAST 30 MINUTES AND RASH AND ITCHING HAD SIGNIFICANTLY IMPROVED AT 30MINUTE MARK. PT STATED SHE WAS FEELING MUCH BETTER AND DID HAVE BROTHER IN PARKING LOT WAITING TO GIVE HER A RIDE. PER PT.  WENT OUT WITH PHARMACY MANAGER, AJ, AT LAST CHECK - IN WITH PT.  WILL FOLLOW UP WITH PT
Patient had a severe side effect of fever & chills for 1 day after the shot was administered.
Given FLUMIST at 2pm on 11/7 - had prolonged seizure and taken to ER 4pm. Had more seizures in ER. Patient is a 16 y.o. male w/history of viral encephalitis in 2009, and known seizure disorder who presented on 11/7 with prolonged seizure. Per Dr's note (peds neuro): Mom reports that over the past 4-5 days patient has been complaining of extreme fatigue and myalgias. On day of admission he stayed home from school due to fatigue. Around 4pm yesterday mom reports patient had a seizure with unknown duration (mom feels approximately 2-3 minutes) described as generalized tonic-clonic with cyanosis. She called 911 - patient had stopped seizing by time EMS arrived. Patient had 2-3 more seizures in the ER described as bilateral arm stiffening with right leg drawn up, each lasting 1-2 minutes. Also had periods of retching/nausea in ER. Patient has had fevers with tmax of 38.1, normal CBC, CMP and CRP. ED course: VPA 1 gram load and ATIVAN 0.1 mg/kg IV x1 while in the ER. Last seizure was in December 2012 (also while ill with a virus). Prior to arrival he was taking VPA 750 mg BID. Previously taken KEPPRA but was discontinued due to side effects of anxiety and nausea.
Within 2 hours of shor,  I had difficulty breathing, unable to breathe at times, throat restricting, rapid heartbeat, headache
HAVRIX given to 3 month 24 day old client should have received ENGERIX B.
Itching started about 4:45pm. I just came home thought it was something I ate. I started having itching and irritation to my right. Moments later it started to swell, and it felt heavy. We then went to Urgent Care at about 9:30pm. The Doctor came in looked at my eye and told me he didn't think it had anything to do with the vaccine and he gave me Hydroxyzine Pamoate 25mg. I went to the pharmacy and my husband put ice on my eye and the medication just made me sleep. After about two days of ice and rest my eyes started to resolve. *Not sure if this had anything to do with the shot but every now and again, I will have a itching fit* They last for about a hour until I start taking Benadryl.
Almost immediately got a headache that I couldn?t get rid of even with medication. I have a 102 degree fever and sweating a lot. Had the shivers last night, was very cold. Tried everything i could to get rid of the fever as well, it wouldn?t go away. I felt completely fine up until I got the vaccine.
FEVER, PAIN AT INJECTION SITE, HEADACHE Narrative:  FEVER 101; SYMPTOMS LASTED X 2 DAYS  Other Relevant History:
10/28/21: admit weakness, lack of appetite, mild non-productive cough X1week duration with new syncopal episode.  COVID+ test on admission.  RA sat 88% placed on 2LNC, RR 24-26, HR 90, afebrile.  Admit with acute hypoxemic respiratory failure with multilobular COVID PNA and mild AKI CRT 2.4.  Started on IV remdesivir, IV decadron, IV ceftriaxone, IV doxycycline, combivent, heparin SQ. 10/29/21: patient desatting, tachypnic, accessory muscle use.  Placed on 15L HFNC and NRBM.  ABG 7.30/40/50/19.9/BE -6 sat 87%. 10/30/21:  renal function improved CRT 1.6. Started on baricitinib. d-dimer 877 ferritin 1090 10/31/21: AM:  d-dimer 902 ferritin 3500 dopplar negative for DVT.  started on Lovenox 10/31/21:  PM:  HFNC40% and
complaining of pain in her arm still; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (complaining of pain in her arm still) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (complaining of pain in her arm still). At the time of the report, PAIN IN EXTREMITY (complaining of pain in her arm still) had not resolved.            Reporter reported that their grafther received his 2nd shot back in April  No concomitant medication was reported. Treatment medication was not provided.   Reporter did not allow further contact
nausea; red spot on her arm; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "red spot on her arm"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain". Additional information: The patient is scheduled for a mammogram this Thursday. She was told that she should not have the mammogram since she received the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 17SEP96 & 18SEP96 7:30 parent noticed hives on child;8:40 hives covered the child whole body;the child acted normally x/for scratching ears;seen by MD who prescribed DPH;
This spontaneous report as received from a physician refers to an unspecified number of unspecified patients. The Physician called to report that an unspecified number of unspecified patients may have been administered PROQUAD (Merck) (Lot #, dose/frequency, route unspecified) that were improperly stored on unspecified dates from May 2012 to December 2012 at an unspecified healthcare facility. No adverse effects reported. This was one of several reports that received from the same source. Additional information is not expected.
Leg reddened area to left deltoid approx 4" in diameter hot to the touch treated with Benadryl PRN.
Puffy eyelids and irritated eyes the evening after getting 4 year shots (DTaP, IPV, MMRV).
About 5 days after receiving PREVNAR 13, patient experienced rash, swelling, redness, itching and pain at site.
This case was reported by a consumer via call center representative and described the occurrence of flu like symptoms in a female patient who received SHINGRIX for prophylaxis. On 10th June 2018, the patient received SHINGRIX. On 10th June 2018, several hours after receiving SHINGRIX, the patient experienced flu like symptoms, muscle pain and chills. On an unknown date, the outcome of the flu like symptoms, muscle pain and chills were not recovered/not resolved. It was unknown if the reporter considered the flu like symptoms, muscle pain and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At around 4 PM, the patient received SHINGRIX. Initially, the patient was fine and at the night the patient started having flu like symptoms, slight chills and her muscles were hurting. The patient did not want to answer any questions to file a report.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 13-NOV-2014, the patient was vaccinated with a dose of M-M-R II (therpay type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Sign: Localized swelling and tenderness of the injection site Symptom: minor pain/tenderness with tactile stimulation persisting continuously for at least 1 week, to the present day. Treatments sought: None. Event was not thought to be of serous concern. Outcomes: N/A
All my flu shot done was make the injection site a bit sore; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via the agency through social media.  This case was linked to cases 2020SA294125, 2020SA294157, 2020SA294157, 2020SA294158, 2020SA294166, 2020SA294144, 2020SA294173 and 2020SA294145.  This case involves a patient of unknown age whose all flu shot done was made the injection site a bit sore (vaccination site reaction), while patient was treated with influenza usp trival a-b subvirion no preservative vaccine [Fluzone].  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patients all flu shot done was made the injection site a bit sore (vaccination site reaction).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
N17.9 - AKI (acute kidney injury) J18.9 - Pneumonia
Pt complained of Headache and flu-like symptoms that persisted for 1 day after the vaccine was administered.
GUILLAIN-BARRÉ SYNDROME; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnic origin. 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: Unknown and expiry: unknown) dose was not reported of frequency 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, the patient was diagnosed with guillain-barré syndrome, and has been hospitalized multiple times since April or May 2021. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain-barré syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This spontaneous report concerns a patient of unspecified age/sex/race/ethnicity was diagnosed with Guillain-Barré Syndrome (GBS) after an unspecified duration from receiving Janssen COVID-19 vaccine.  It was reported that the patient have been hospitalized multiple times.  No other details reported.  The information available precludes a complete and meaningful assessment.  The information regarding other potential etiologies is  insufficient, and the occurrence of her symptoms could represent background incidence of such events in the general population. Considering the temporal relationship, the events are assessed to have an indeterminate relationship with vaccination.
Menstrual changes for 3 cycles after the booster. I have been having pretty serious PMS symptoms with no history of PMS symptoms ever. My period has been a couple of days late each time. I am on hormonal birth control so this is very unusual. The week before my period onset, I had serious anxiety symptoms and breast tenderness.
Approximately around 6 months after my booster shot (Dose 3) I contracted COVID-19 and experienced the following symptoms: Sore throat, it was incredibly bad and I never had that kind of sore throat before. I took a home test for COVID-19 and it was positive. I went to my doctor and suggested that I take an over the counter medicine, CIPROCAL to numb the pain in my throat. It took about 3 days for me to fully recover and be back to normal.
Swelling, redness and warm to touch of arm from injection site to elbow with itching and some tenderness. Clarinex and ice packs.
Delivered healthy baby girl on 4/1. Dischared from hospital on 4/2. On 4/5 experienced a sudden rise in blood pressure to 210/106, severe headache, taken by ambulance to the hospital.  Received magnesium sulfate via IV to prevent seizures and treated as if pre-eclampsia had occurred postpartum.