chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I take hydroxychloroquine for undifferentiated connective tissue disease, and since getting the vaccine, it seems as though the hydroxychloroquine isn't working as well. I've had a reemergence of symptoms that had been nearly eliminated, as well as stomach upset as a side effect of the medicine that had gone away prior to the vaccine.
Patient received 1st dose of COVID-19 vaccine ~12 days prior to onset of symptoms: fever, headache, cough, shortness of breath.   Admitted to hospital with + COVID-19 and new diagnosis of diabetes mellitus.  On Day 3, he suffered a stroke (left MCA) and required thrombectomy.  On Day 6, he suffered another stroke - right MCA.   He remains hospitalized, pending plan for placement
Employee is a Pharmacy Technician who got her Flu-Inactivated, vaccine at Flu clinic in hospital on 9/26/15 at 8 pm and 2 hours later, at 10 pm felt, chills, head congestion w/ clear runny watery nose, achy. She went to ER and was diagnosed with a "viral respiratory illness". Note-exam of left deltoid=normal.
Onset of acute generalized rash and fever approx 4 days after vaccines given. Erythematous macular/papular eruption, prevalent on cheeks & upper thighs.
I experienced a minor recurrence of shingles less than two weeks after receiving the Pfizer Covid19 vaccine, in spite of having received the Shingrix vaccine in the past. The vesicles appeared on my right upper shoulder blade. The infection was treated with a short course of Valtrex, which cleared it within a week.  I had previously suffered a very serious case of shingles in the early 1990s.
Swollen left armpit, cool compress and motrin, no noticeable changes.  Sore neck muscles bilateral, cool compress and motrin, no noticeable improvement.  Both started 01/06/2022 around 12pm can continue on despite attempts to treat.
Headache; Fever; Chills; Sense of smell affected greatly as was sense of taste; Sense of smell affected greatly as was sense of taste; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 19Apr2021 at 11:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included reflux and COVID-19 since Dec2020 and stopped on an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included paracetamol (TYLENOL), melatonin (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all taken from unknown dates for unknown indications and unknown if ongoing. The patient previously received povidone-iodine (BETADINE) on an unknown date for unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 29Mar2021 at 11:45, as a single dose for COVID-19 immunisation. On 20Apr2021 at 10:00, the patient experienced headache, fever, chills, sense of smell affected greatly as was sense of taste just like when the patient had COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, fever, chills, sense of smell affected greatly and as was sense of taste were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
got shingles after the shot / Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got shingles after, getting the shot. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
This spontaneous report as received from a 62 year old female consumer refers herself. No pertinent medical history and no drug reactions/allergies. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# not reported, expired date 09-APR-2013). There was no concomitant therapy. The patient reported an AE that occurred after receiving ZOSTAVAX. The patient was admitted into the hospital (approximately in October 2011) with severe swelling to the ankles, rash and high uncontrollable fever. The onset date of all AEs was 02-OCT-2011. The patient saw the doctor and no treatment was given. At the time of reporting, the patient was recovering. The relationship between all events and ZOSTAVAX was not reported. Additional information has been requested.
? Cough ? Headache ? Generalized Body Aches ? Covid-19 Screening     exposure ? Fatigue Low grade fever
06/16/2022 I was congested. It seemed to clear up, but I had a postnasal drip that was irritating my throat. Over the next 2-3 days, I had a little bit of a scratchy throat with a postnasal drip on the right side only.  On 6/20/2022 I woke up with a dull headache and very light fatigue. Towards the end of the week, around 6/22/2022, I started to lose my voice. I never had a sore throat, it just stayed scratchy. On 6/29/2022 I felt a stinging and painful sensation and a saw a spot on my right inner thigh.  It did not go away. I felt it a few times that night with a little bit of throbbing added to the stinging in my thigh. That night I woke up and felt it again in the same specific spot. I called my doctor on 7/01/2022 and went in to see him on 7/2/2022.  He felt something in the area where I was feeling the pain. He did not think it was anything to worry about.  He did not feel it was a blood clot. I was given an order for an ultrasound in case I wanted to go in to get it checked out. It went away on 7/4/2022, so I did not go in for the test.  When I push on it now, it does not hurt. The only lingering symptom is my voice. My doctor told me to take Flonase and to rest my voice as much as I can.
12/13/2013 client at clinic to receive 2nd dose of varicella vaccine. At time of visit client voiced after receiving varicella vaccine on 10/29/2013 that evening rash occurred ar var. vaccine site. Rash described as flat, red, warm to touch and covered large area of arm and lasted x 1 month. Did not seek medical attention or notify Health Dept. until today.
41 y/o F w/ PMHx panic d/o presenting with difficulty talking, reporting ?feeling a lump in my throat,? chest tightness/shortness of breath, hazy vision, and tingling in bilateral arms/hands 10 minutes after her first dose of Pfizer (given at 12:03 PM - symptom onset at 12:13 PM).  Reports symptoms started suddenly with chest tightness and hazy vision which then resolved after approximately one minute. Reports symptoms then localized to her throat and she felt like she had to gag. After 2-3 minutes of having difficulty talking, she reports she feels like she can fully talk again. Reports her throat swelling sensation has resolved and only residual symptoms are a ?caffeine rush feeling? and tingling in her hands.    She did not have water or breakfast today and endorsed feeling nervous prior to her vaccine today.    Only medical hx includes panic d/o (occasional - last panic attack 1.5 yrs ago). Not on daily or prn medications and never has been; no h/o seeing psychiatry or therapy. Reports her current symptoms feel different than other panic attacks.  No other chronic conditions or daily meds. Denies h/o serious allergic reaction to any medications (oral, intravenous, injections). Reports feeling dizzy with Excedrin PO 10 yrs ago. Never been given Epinephrine. H/o hay fever with weather changes - does not take medications.    Pt denies swelling of the face, itching of the skin, rash, CP, dizziness, extremity weakness, HA, n/v, or abdominal pain.
The second dose was administered subcutaneously in the left arm. The dose was repeated in the right arm intramuscularly.
After receiving the 3rd fizer vaccine booster on April 1st 1st, at 4 PM I was fine the remainder of the night. The next day April 2nd at 11am I noticed my breathing felt shallow, then I noticed other flu like symptoms chills,fever (100.4), muscle soreness,  joint pain, headache. The following day 4/3/22 my flu like symptoms subsided though the shortness of breath was still present. The shortness of breath has continued and is still current at of 4/8/22 5:00pm. Though I at times have also had labored breathing, feeling of exhaustion from very little work, chest pressure and pain, along with mild palpitations. I was prescribed an Albuterol inhalor to be used 2 puffs evey six hours on 4/7 which I started talking and have used 4 times now without any changes outside of the 1st 15 minutes after dosing. I then went to urgent care on 4/8 and received an EKG, chest xray, covid test, influenza test. All within normal range and appearance. My blood pressure was elevated 160/106, temp and oxygen normal. Diagnosis was "possibly bronchitis", I refused medication and aggreednto deeper breathing exercises. I still feel a pressure in the left of my chest, difficulty to breath and labored breathing which impacts my daily living and work lifestyle.
DIABETIC; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (DIABETIC) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DIABETES MELLITUS (DIABETIC) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS (DIABETIC) outcome was unknown.            Company comment: This is a spontaneous case concerning an adult female patient on treatment with Adalimumab for an unknown indication, who experienced the serious (medically significant) unexpected event Diabetic, on an unknown date after the third dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Risankizumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   All doses of vaccine including booster taken one in once.   No treatment information was provided.  The reporter's causality with Skyrizi (Risankizumab) for the event of Diabetic was not provided.; Sender's Comments: Company comment: This is a spontaneous case concerning an adult female patient on treatment with Adalimumab for an unknown indication, who experienced the serious (medically significant) unexpected event Diabetic, on an unknown date after the third dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Risankizumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
posterior vitreous detachment; herpes keratitis; postherpetic neuralgia; herpes zoster/shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 13-NOV-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location and route of administration were not reported), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered severe headaches with a vesicular rash on the left side of the forehead accompanied by blurred vision in the left eye. The patient was diagnosed with herpes zoster/shingles, post herpetic neuralgia, herpes keratitis (herpes ophthalmic) and posterior vitreous detachment. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for all the events was not recovered. The reported considered all the events to be related to zoster vaccine live (ZOSTAVAX).  It was considered that the herpes zoster, post herpetic neuralgia, herpes ophthalmic and vitreous detachment were disabling events.  Upon internal review, the vitreous detachment and herpes ophthalmic were medically significant events.
Temperature of 101; body aches; Bone hurts; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature of 101), PAIN (body aches), BONE PAIN (Bone hurts) and MYALGIA (Muscle Pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Temperature of 101), PAIN (body aches), BONE PAIN (Bone hurts) and MYALGIA (Muscle Pain). At the time of the report, BODY TEMPERATURE INCREASED (Temperature of 101), PAIN (body aches), BONE PAIN (Bone hurts) and MYALGIA (Muscle Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) Temperature of 101.         Action taken with mRNA-1273 Moderna COVID-19 Vaccination was Not applicable.  No Concomitant medication was provided.  No Treatment medication was provided.
Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination. Child had no ill effects thus far
4 days after second dose of Rotavirus vaccine baby developed diarrhea lasting 5 days then vomiting and T 101 degrees, no dehydration. Symptoms have resolved.
patient was given expired PENTACEL vaccinations with no reported adverse event; Initial information received on 06-Jul-2021 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2021SA225602 and inquiry number 00669898 (same reporter).  This case involves an infant patient who was given expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccinations (expired product administered).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Past medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On 05-Jul-2021, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ325AA and expiration date: unknown) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event 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 guidelines. 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.
This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 6 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 6 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date for prophylaxis. Subjects' medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism for flare, therapeutic selection or development.
I received the pneumococcal PPV23 Merck & Co. Lot number 0556AE .5 mL VIS version 10/6/09 at the clinic on 10/16/2012. By that evening I was experiencing redness, soreness around the injection sight, headache, nausea but did not have a fever. By the next day there was a 4 inch circular raised rash at the sight and a very swollen and extremely tender lump 1 1/2 inch around anterior to the injection site. I still had the headache, nausea, and some diarrhea. I went back to the shot clinic and a doctor looked at it quickly but said the shot may have hit a lymph node and not to worry. After about the 3rd day the lump and tenderness as well as the headache had subsided. The rash, however, remained for a few more days. I had noticed some roughness on my upper back but couldn't see much. On October 29 after showering I noticed probably 20 purple oval/irregular spots on each of my lower legs. I am IN REMISSION for Wegener's Granulomatosis -6 months oral CYTOXAN and prednisone ending in Feb 2010- and knew the disease could show up on skin or in my lungs. Oct 30 In went to a local Emergi-Care and the doctor drew some bloodwork/urine sample and looked online and felt the purple spots looked like vasculitis photo and showed to me. She called my immunologist. He wanted the lab results. We were leaving town the next morning for 12 days but my doctor felt I could go. The labs came back negative over the following 12 day the rash spread to my stomach, upper and lower back, thighs and arms, and chest. During that time my immunologist was monitoring my rash via photos I had emailed. He recommended skin biopsies using immunofluorescence staining. I went to a dermatologist for the biopsies. He took three and they all came back Lichenoid Dermatitis. My immunologist felt that this indicated the rash was from a drug interaction or from the vaccine. Since there had been no changes to my medications that left the pneumococcal vaccine as the likely cause. I had bloodwork/urine sample repeated on my return Nov. 13, 2012 and they were ruling out the Wegeners.
Swelling and redness around injection site. Pt went to ER and received steroids and antibiotic.
pt recv vax 28FEB97 & lt upper arm swelled sl & had red spot the size of a nerf football;@ the center was a deep red indurated disk 2 inches across which became severely sore next day;t100.3 orally
Patient started with symptoms approximately 11 minutes after vaccination.  She reports feelings of difficulty swallowing as well as some chest discomfort with radiation up into her head.  She has had similar reactions in the past vaccinations.  Reports no associated rashes at this time.  Has not had any nausea or vomiting.  Does have slight burning sensation in her chest.
Pt called on 5/26/21 to hospital call center.. Pt states he felt pain and pressure in his heart 2 days after getting the Pfizer vaccine on 5/4/21 from the vaccination site and the pain/pressure went away and started again 2-3 days ago with pain level of 3/10 that comes and goes lasting about 20 minutes. Pt states sometimes have rapid heartbeat and felt anxious. Advised pt to go to ED immediately for evaluation and pt verbalized understanding.
My period started early and I bled heavier than usual. Muscle pain for 3 days, flu like symptoms.
Drastic reduction in White Blood cells and platelets. Some time of pancytopenia, leukopenia, or anemia.