chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced redness/itching on neck/upper back during 15 minute monitoring period and was kept for an extra 15 minutes, in which this improved. Patient received first dose Pfizer lot# EK 5730 in 12/17/2020.
On 12/23/2021, I received my first Pfizer booster for COVID-19. On 3/23/2022, I had mild flu-like symptoms that included fatigue, headaches, body aches, and fever. I also lost my senses of taste and smell for a few days, but they returned to normal after a short time. I did an at-home test for COVID that day, and the result was positive. I called my doctor's office on 3/24/2022, and he prescribed me Paxlovid. I also took Tylenol for my headaches. I would say that both the Paxlovid and Tylenol were effective, because the symptoms were gone after about 3 days.
sore arm; 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 (sore arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported No treatment medication details was reported
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: injection site redness light swelling of arm resolved in 30 min-Mild
19jan96 pt had equivocal titer. nurse reported 12 negative titers.pt recv vax 29AUG95;
inj site, redness about 1 1/2cm since 1wk p/shot;it completely resolved by 24JUL98;
PATIENT STATED THAT SHE WENT TO ER AND WAS INFORMED THAT SHE HAS GUILLAIN-BARRE SYNDROME, GBS.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 38 year old male. 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: 206A21A, and 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 20210960300.
-10/2/23: Patient returned to the clinic with report of 2 or 3 hives on her right arm about 2 hours after her injection.  Denied any additional symptoms, recent contact with anything new or ingestion of anything new.  Patient advised to take diphenhydramine 25-50mg  and be seen in ER if any respiratory or worsening of symptoms occurred.  -10/5/23:  Patient returned to clinic stating that she has been taking diphenhydramine 25-50 mg since 10/2/23.  Reports that the hives have gone away but last night she developed some lip swelling/itching that has continued this morning despite taking 50mg of diphenhydramine last night.  Denies any respiratory difficulties or any other symptoms and denies eating anything new or different than her usual diet.  Pt advised that she could also take a famotidine tablet and should be seen in the ER due to continued allergic reaction type symptoms. No acutely visible lip or facial swelling noted by provider but patient states she can feel that her upper lip is swollen as is the area above her lip and into her nose.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 17-MAY-2016 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K008927, expiration date 17-MAR-2016, route and dosage not specified). No adverse effect reported. Additional information has been requested.
Runny nose, coughing, fever of 102 deg. F, keep spitting up liquid (milk, water, juice). Taken infant Tylenol for fever.
Pt developed redness, swelling and heat per pt. No treatment. She never had it looked at and informed us of it today (11/21/01) and that it was better.
The patient reports that she was feeling fine until she had a flu vaccine on Monday.  She reported the next day on Tuesday she started feeling weak tired chilled off balance and somewhat confused.  Other symptoms at the time of admission 10/06/2022 included myalgias, arthralgias, and nausea, word finding difficulties, speaking gibberish , unable to walk unassisted. later in the night10/06/2022 she developed atrial fibrillation. the neurologic symptoms of speaking gibberish and unable to walk resolved the next day.  She also had fever to 103 on 10/06/2022.
She got her vaccine, was fine and on the next day during eating, she got severe stomach pain and thought she was going to throw up, hurting really bad.  She started taking stuff to calm it down, and then finally went to bed.  She fell asleep about 2:00 AM and when she woke up was much better, it hurt a little the next day but nothing severe, and has been fine since then.
Parents noted rash on upper front torso of infant 5 minutes after receiving oral Rotavirus. Pt received Benadryl and was monitored for 30 minutes. Rash resolved prior to their departure.
pt with 1- of dry cough followed by fever to 102 on 5/7/21. Pt was not hypoxic on home but on arrival to ER had hypoxia, requiring high flow NC. condition has not improved despite treatment for bacterial infection, PE and atypical pathogens ( possible tick bite). Admitting inflammatory CRP > 15 , Ferretin > 1100, IL6 > 50 and D dimer > 5. Pt with mild thrombbocytopenia  COVID IG G pending
Breaking out in a rash in different areas of the body. Can only be controlled by Zyrtec.  Extreme itchiness with welts. Goes away with antihistamine.
Information has been received from a physician with had hay fever who on 02-FEB-2009 vaccinated himself with a 0.5 ml first dose of PNEUMOVAX 23 intramuscularly into his left deltoid. There was no concomitant medication. On 03-FEB-2009 he experienced a fever of 102.5F for 3 days, rigors, sweats and cellulitis from the left shoulder to left elbow. It was reported that the cellulitis area first started as a little red spot with pain and the developed into the cellulitis from the left shoulder to the left elbow. It was reported that the physician had "general upper respiratory" symptoms such as cough, vomited several times on 03-FEB-2009 and could not stay awake. At the time of the report, the fever was gone however the area of redness (cellulitis area) is extended. It was reported that the physician was taking AUGMENTIN XR two tablets twice daily and prednisone. There were no diagnostics studies performed. It was reported that the physician considered jumping into a cold pool and was also taking around the clock ibuprofen alternating with TYLENOL to lower his fever as intervention to prevent a serious criteria. The physician talked with another unspecified physician. The reporting physician considered fever, rigors, sweats, "general upper respiratory symptoms" could not stay awake, vomited several times and cellulitis to be life threatening and other important medical events. Additional information has been requested.
Back pain, wheezing. EMT was called, Epinephrine was given. Patient  refused ER, Doctor and Hospital.
Verbalize feeling Dizziness, was evaluated on site by EMS and released home at 10:42 am feeling better.
EXTREME TIREDNESS 3 1/2 HOURS AFTER 1ST SHOT.  HEADACH 5 HOURS LATER AFTER 1ST SHOT (STILL HAVE HEADACH NOW DAY 6 TUESDAY) NEXT DAY SLEPT 23 HOURS (EXTREME TIREDNESS) JOINT PAIN IN WRISTS/ANKLES AND BACK ON DAY 3 LASTING 2 DAYS, SWOLLEN LYMPH NODE UNDER LEFT ARM FOR 1 1/2 DAYS, NAUSEA FOR 3 DAYS, VERY ITCHY BACK/WRISTS ON DAY 3 (LASTING 3 DAYS).  ONE THING I DID NOTICE IS THAT MY BREATHING IS GREAT.  NEVER FELT SO CLEAR.    ANTIHISTAMINE 3 TIMES A DAY (ALLERGRA, BENADRYL)
First I  developed nodule under left arm pit then went to right arm pit a few weeks later then developed off and on numbness and tingling of finger tips was predominately on the left hand and   then a few weeks later moved to right hand and it continues
severe brain fog; trouble processing and articulating thoughts; Slurred speech; Trouble with physical balance; booster; arm hurt; body ached; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 09:45 (Lot number: FE3590) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing); "reactivated EBV" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "SIBO" (unspecified if ongoing); "sensitive to gluten" (unspecified if ongoing), notes: sensitive to gluten; "allergies: dairy, foods with histamine" (unspecified if ongoing); "mold toxicity from mycotoxins" (unspecified if ongoing). The patient had no COVID-19 prior vaccination. Concomitant medication(s) included: FLU taken for influenza immunisation, administration date 13Oct2021; MELATONIN; BLISOVI FE 1/20; and numerous vits and supplement (unspecified). There was no other vaccine administered on same date with the suspect product. Past drug history included: Pantoprazole, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot Number: Unknown, administered in left arm, Vaccine Administration Time: 01:30 PM), administration date: 04May2021, when the patient was 49 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot Number: Unknown, administered in left arm, Vaccine Administration Time: 02:00 PM), administration date: 13Apr2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (disability) with onset 10Nov2021 09:45, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (disability) with onset 10Nov2021, outcome "recovered", described as "arm hurt"; PAIN (disability) with onset 10Nov2021, outcome "recovered", described as "body ached"; FEELING ABNORMAL (disability) with onset 11Nov2021, outcome "recovered", described as "severe brain fog"; COGNITIVE DISORDER (disability) with onset 11Nov2021, outcome "recovered", described as "trouble processing and articulating thoughts"; DYSARTHRIA (disability) with onset 11Nov2021, outcome "recovered", described as "Slurred speech"; BALANCE DISORDER (disability) with onset 11Nov2021, outcome "recovered" (14Nov2021), described as "Trouble with physical balance". Therapeutic measures were not taken as a result of pain in extremity, pain, feeling abnormal, cognitive disorder, dysarthria, balance disorder. Clinical course: At night arm hurt and body ached. Next day (11Nov2021) severe brain fog, trouble processing and articulating thoughts. Slurred speech. Trouble with physical balance from Thursday (11Nov2021) to Sunday (14Nov2021). Adverse events start date/time was reported as 10Nov2021 03:00 AM (pending clarification). COVID-19 was not tested post vaccination.
Patient was filled with severe pain when ready to eat and cried in pain in the upper stomach, chest area. Severe pain in upper stomach, severe crying just prior to eating; pain associated with eating continued and behavioral changes including head-banging, crying for little apparent reason.
Patient felt lightheaded and dizzy Patient had syncopal episode which followed immediate urination; episode witnessed by staff nurse Patient seen by medical team and vitals were stable  Patient refused medical transport and signed AMA form Patient?s husband will be picking patient up
This 68 year old male received the Covid shot on  3/17/21  and died  5/21.
Patient developed a large and pain boil on his anus which broke after 4 days. Stomach issues with dry heaves when ingesting anything even water. Patient took ginger root and was able to recover after 4 days. Patient stated the same thing happened after his PPSV23 vaccine.
Information has been received from a registered pharmacist concerning a 69 year old female with sulfonamide allergy and a history of mild anxiety who on 20-APR-2009 was vaccinated with the first 0.65ml dose of ZOSTAVAX (Merck) (subcutaneous injection, lot# 664091/0140Y). Concomitant therapy included potassium (unspecified), CRESTOR, quinapril HCl, verapamil, alprazolam, SYNTHROID and HCTZ. The pharmacist reported that the patient developed non-shingles like rash, anxiety, and confusion after receiving a dose of ZOSTAVAX (Merck). The rash appeared on her neck lines. The rash disappeared but the patient still had some anxiety and confusion after receiving a dose of ZOSTAVAX (Merck). The rash appeared on her neck lines. The rash disappeared but the patient still had some anxiety and confusion. The patient was hospitalized. The duration of hospitalization and the name of the hospital were unknown. At the time of the report, the patient's outcome was unknown. No further information is available.
At 8:55 AM, on June 1, 2021, a slight tingling was felt in the fingertips of my rught arm.  I then felt an increase of heart rate and my husband noticed my breathing was more rapid.  I began to feel a slight tingling on the back undersides of my tongue and the top of my throat.  I got up to walk and had to sit back down due to throat swelling and breathing reatriction.  It was apparent to others around me due to the thick choked breathing I was experiencing.  I felt my throat and jawline/cheeks feel puffed up.  A nurse appeared to assist me, check my breathing and heart rate, and monitor my symptoms.  I was not given an EPI injection, but was treated qith an adult dose of liquid benedryl, and 30 mg of Prednisone.  I was then instructed to take benedryl at 4 hour intervals along with a dose of Zyrtec one I got home and again at bedtime then a single dose of Zyrtec for the next few days.  I stayed an extra 30 min after the initial reaction took place for monitoring.
since getting the COVID 19 vaccine on April 7, I had at least 6 times "heart beat stopped" feeling, two times I almost passed out. I never had that kind of feeling before.
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8° (10 mins); This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded to Agency on 06-JUL-2022 from a consumer.   The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.   FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded to Agency on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003724, MCM-003726, MCM-003729, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003761, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
thought  pt had flu because of flu-like sx;high fever caused sz that lasted for 3 to 4min;pt was unable to respond to communication & eyes were rolling to back of head;seemed better 5hr later @ hosp when temp went down to 101;
Two days after receiving the Johnson & Johnson  vaccine, the patient (myself) awoke in the middle of the night with painful cramps in the lower abdomen. She got up in the morning to some blood in her underwear. The next day, she awoke to an immense of amount of blood coming out of her vagina to the point it was dripping down her leg. For context, the patient received the Mirena IUD several months ago and had not had a period since receiving the IUD, besides spotting. This is why these events were startling since she had not had a period in several months and this immense bleeding and cramping  was abnormal to her. As of today (4/15/2021), she has been experiencing heavy bleeding for 5 days. Again, this is very abnormal to her since she has not experienced a period for several months.
Headache & Myalgia Employee reports self-treating w/: "Just Aleve, I took 2 Aleve earlier, just the standard OTC bottle."
Patient finished observation period and went to his car 50 minutes post vaccine where he then started feeling tingling to tongue and fat and fuzzy feeling. Returned to site - received Benadryl IM with good resolve. DC'd home to care of friend for further observation.
draggy & cranky 25APRday, PM 25APR devel cough & asthma attack ensued;lt arm red & swollen @ inj site;most of upper arm reported by mom;mom took pt to MD 26APR97 for cont asthma sx;suspects vaccine was trigger;
This spontaneous report as received from a nurse refers to a 7 months 12 days old female. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Patient became nauseous within 15 minutes of receiving the flu shot and vomited approx. 45 mins afterward. She continues to complain of nausea and slight dizziness. VS: B/P 118/84, AP 72, R 20.
Headache, Myalgia, sore arm, "taking larger breaths than normal" Narrative:  1/19 - onset of headache, body aches, "taking larger breaths than normal." He missed work due to these symptoms... 1/21 -  woke up feeling back to normal.
Patient reported that he has shortness of breath for 2 days after the 2nd dose of the Moderna vaccine
Breakthrough COVID asymptomatic 59-year-old male, with PMHx of muscular dystrophy, bedridden at his baseline, presents to ED with worsening left thumb nail-bed infection for the past few days, patient states he had trim his cuticles, after which, he noted worsening erythema, pain, and swelling for that left thumb nail bed, the swelling, started to form a yellow head, patient describes the pain as throbbing, severe, additionally, patient reports developing a decubitus ulcer in his sacral area, he denies any associated fever, chills, sweats, N/V/D, abdominal or back pain, denies CP, SOB, palpitations, cough, symptoms at this time.
Pain in  the right Jaw, below the ear. Felt only when opening  the mouth . Pain mild in nature, no medication taken. Currently  pain is mild and decreasing. Feeling  like there is air in the right ear and mild pain. Pain is similar to pain felt when an airplane is descending. Currently  pain is decreased and improving slowly. No medication taken
Patient passed out after receiving immunization. vaccine received at (6:18 pm)  Patient fell from chair  hit her head on the ground 5 minutes after. I, a health care professional ran out to the patient after mom yelled she passed out. I called for a fan and Ice pack. RPH called emergency services immediately . patient was escorted to hopsital by ambulance.
Redness, induration and warmth at the injection site, measuring 5-6 cm in Diameter.
First shot: Sore arm; This is a spontaneous report from a contactable consumer (patient's sister). A 7-decade-old male patient (reporter's brother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced "first shot: sore arm" on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433387 Same reporter/patient/drug, different dose/AE (reporter's brother, second dose)
This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a Certified Medical Assistant concerning a 24 year old female patient with neurocardiogenic syncope who on 21-NOV-2006 was vaccinated IM with her first dose of Gardasil, lot #653938/0954F. Concomitant therapy included INDERAL. On 21-NOV-2006 the patient experienced insomnia for one month following the administration of Gardasil. She later had the flu from being run down and lack of sleep. The patient desired a prescription for sleep after her next injection. Unspecified medical attention was sought. The patient was reported as recovered. Additional information is not expected.
dizzy & h/a 5min p/vax was feeling dehydrated all day w/dry mouth & achy all over & nausea;
Initially presented with injection site reaction, a red rash on left arm. Rash/irritation progressed to face, patient developed itchiness on facial area. Patient was told to take BENADRYL tablets, follow up w/PCP.
chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive. In March 2021, Pyrexia: 100.7 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not given.