chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache behind the eyes, sore arm, sore shoulder, back pain, stomach ache, drowsiness, bloating, nausea   These side effects began around 10pm on 04/26/2021, and continued to present day
PATIENT CALLED THE PHARMACY AT 9:00AM AND SHOWED SIGNS AND SYMPTOMS OF TONGUE SWELLING, BLURRY VISION AND RAPID HEART BEAT. I NOTIFIED THE PATIENT TO GO TO THE EMERGENCY ROOM IMMEDIATELY.
Pain, swelling, redness, warm to touch about 2-3 inches below injection site.
Day aftrer second shot, temp went to 102.5, used cold compresses on forehead and throat to reduce fever. Few days later, developed shoulder pain. Harsh "hot" pain in shoulder joint, radiating across shoulder blade and up neck to base of skull. Have not reported to doctor, for why bother??? Only pain med I can use is tylenol, and it helps some. Also use ice pax wrapped around  neck.  Pain at times is disabling. Will not take a booster. Also will not advertise this side effect. But have a friend who is also suffering same pain.
Swollen/Irritated/Inflamed tastebuds from tip to rear. Tongue feels raw, painful. Can feel irritation when speaking, swallowing.
got the flu; shot is not as effective; Initial information received on 21-Dec-2021 regarding an unsolicited valid Social Media serious case received from a patient.  This case involves unknown demographics patient who got the flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, formulation, strength, expiry date and lot number not reported via unknown route in unknown administration site) as prophylactic vaccination (Flu).  It seems the shot is not as effective (vaccination failure) several people that got flu shot got the flu (influenza). Not so great Several. Have gotten flu and they had shot; (unknown onset date and latency)  It was unknown if there were lab data/results available  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event.  Seriousness criteria: medically significant for influenza and its symptom vaccination failure; Sender's Comments: Sanofi company comment dated 03-Jan-2022: This case involves unknown demographics patient who got the flu while receiving vaccine influenza vaccine. Case will be reevaluated post further update on concurrent condition during vaccination, underlying disease, laboratory investigations excluding alternative etiologies for the reported event, concomitant drug/ vaccine, which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Subsequently post vax, the pt experienced generalized urticaria. The pt sought unspecified medical treatment.
Sore at injection site for 3 days, then suddenly felt exhausted, weak, could barely stand because of leg weakness, dizzy, lightheaded, foggy thinking, urination problems and constipation. All lasted 5 days, I?m still feeling a bit dizzy but other symptoms have subsided for the most part.
Patient received the 1st Moderna vaccine.  She is only 16 years old.  This was discovered when patient presented for the 2nd Moderna vaccine.
Blistery rash on right abdominal area near a scar appeared 7/21/2018.
Pt. unable to move legs, tender calves to touch, too much pain to walk.  11/18/09 Medical records received for Dos 11/10/09.  Final DX: Myositis S/P vaccine tender calves to touch, painful to walk. Recurrent in March. Urine clear. High myoglobin and CK. ICD 9 Codes: 729.1
Fatigue, low grade fever and injection site soreness starting day 1 after shot and thru day 3 after shot.  Starting day 8 after shot, itching at injection site.  Days 9 thru current day 11 post injection there is redness, swelling, warmth, hard welt, itching, tenderness at injection site.  Redness and welt are approximately three inches in diameter. Also, between 130-330 am on day 10 post injection was severe nausea and chills. Trying Benadryl and topical creams for the welt and itching. No real relief.  Just hoping it subsides soon.  Notified family doc of side effects/reactions.
sore arm; bit tired; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and tiredness. In December 2021, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the 1st shot a week ago from the date of reporting.  The patient experienced sore arm and a bit tired the next two days, but nothing really noteworthy, considering that strong reactions to vaccines were common for the patient.  The patient said second jab would be a different story, but he/she ready for it. The follow-up would not possible, as no contact details were available.
Information had been received from a medical assistant referring to an unspecified number of patient of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (dose, lot number and expiration date were unknown), which were following a temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
SON (PHYSICIAN) STATED THAT THE DAY FOLLOWING VACCINE ADMINISTRATION, PT WENT INTO CONGESTIVE HEART FAILURE AND WAS ADMITTED TO HOSPITAL FOR A WEEK -- HAD NOT PREVIOUSLY SUFFERED FROM CHF BUT DOES HAVE Hx OF CAD.
her arm is feeling sore where she got the vaccine administered; because of the syncope she experienced yesterday / passed out; experienced some incontinence; became dizzy; felt nauseous; This spontaneous report was received from a 15-year-old female patient, who referred to herself. Her pertinent medical history included asthma. The patient's concomitant medications included unspecified multi-vitamins. She did not have any drug reactions or allergies. On 28-AUG-2019, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported) for Human Papillomavirus (HPV) prevention. On that same day, approximately 10 - 15 minutes after the vaccination, while the patient was a passenger in the car, she became dizzy, felt nauseous, passed out and experienced some incontinence. The patient informed that she recovered form the events about 10 minutes later. Subsequently, she went back to her pediatrician's office where "they said she was fine".  On 29-AUG-2019 (reported as today), the patient's arm felt sore at the vaccine administration site. On that same day, the patient went to an unspecified hospital, because of the syncope she experienced a day before, however she did not received any treatment.  The patient had no lab diagnostics or studies performed.  The outcome for the event vaccination site pain was reported as not recovered. The causality assessment was not provided.  Upon internal review, the event of the syncope was determined to be medically significant.
Noted above red, itching rash over site of injectiion.  Warmth noted, some headache associated.
Information has been received from a RN concerning a adult male patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 641532/1353L).  Subsequently, the patient developed swelling, redness and soreness at the injection site.  It was reported that the patient sought medical attention.  The outcome of the patient's swelling, redness and soreness at the injection site was unknown.  The reporter expressed a concern regarding the lot.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The reporter also mentioned a second male patient that had a similar experience following vaccination with pneumococcal vaccine 23 polyvalent (Lot # 641532/1353L) (WAES # 0211USA00052).  Additional information has been requested.
Vaccine error not adverse event. Pt answered screening question for previous dose as a "NO" and upon entry into our EHR, Pt had had a Moderna vaccine in April 2021. Pt did not recall Moderna vaccine injection history during initial screening questions.
Guillain-Barre Syndrome - LE Weakness, visual disturbance. 12/07/09 DC summary, ED and Hospital records received for DOS 01/19/08-01/21/08. Presented with lower extremity weakness x 1 week. Weakness started in calves and then developed difficulty walking up stairs. H/o muscle tenderness x 1 month. Neurology consult, Rehabilitative medicine consults obtained. Discharged home with walker and outpatient PT, OT. DC DX: Guillain-Barre syndrome
Pt devel encephalopathy thought to be encephalitis-unknown cause; (initially c/o numbness rt hand x 2 wks opposite arm from inject then deterioration of motor skills & mental status over 5 days;
approx 2inch area on rt hip-red, hard, painful, warm to touch;low grade fever;still has pea sized knot-25 days p/vax;
Headache,body aches. low grade fever,fatigue chills Took Tylenol and bedrest
COVID-19 I tested positive for COVID-19 on July 6, 2022 only symptom I experienced was a runny nose. I was prescribed  molnupiravir 200mg for 5 days. I started to feel better. I tested again on July 12, 2022 and the results were negative.
1/7/22 Pt is a 31 year old female who tested positive for SARS-CoV-2 on 12/24. She returned to work on 1/7 after finishing isolation. She presented to the ED with lightheadedness, SOB and tachycardia. She works in a hospital and was reommended to present to the ED. Per D/C from the same day  Murmur and recent Covid-19 dx who presented to Observation 1/7/2022 with chief complaint of heart palpitations and shortness of breath. Labs and imaging on admit: K 3.3, Mg 1.8, Trop x2 and NT-pro BNP negatibe, WBC 11.17. EKG sinus tachycardia non-specific ST abnormalities. CXR non-acute. BLEVD and CTPA negative.    1. Palpitations with Dyspnea: patient recently with Covid-19 as discussed, returned to work today and reportedly became lightheaded, short of breath and palpitations with HR 160's on fitbit after climbing a flight of stairs. No current chest pain but patient is concerned about myocarditis. Trop x2 and NT-pro BNP negative.  EKG sinus tachycardia non-specific ST abnormalities. CXR non-acute. BLEVD and CTPA negative. Suspect in setting of dehydration and recent Covid, s/p 2L IVF bolus with improved rate 90's on tele in ED. OSV neg, repeat EKG with sinus tachycardia and TTE on 1/7/21 with EF: 69%, and essentially normal study CRP/TSH wnl. Tele.EP  Evaluated and recommended no further inpt work up and no need for meds currently especially in light of pregnancy. If persistent, can consider outpt holter monitoring.   Monitor.  2. Covid-19 Infection: Vaccinated and just got booster. Recent Dx 12/29/21. Patient endorsed congestion and stable on RA. CXR non-acute. BLEVD and CTPA negative. Currently on RA and out of isolation.  3. Hypokalemia: 3.3 on admit, Mg wnl. Monitor and replete PRN.   Improved 1/8/22. Will give small dose to get K>4, mag level wnl. 4. Leukocytosis: 11 on admit. No infectious symptoms. Suspect reactive. Trended.  5. Pregnancy: +test on 1/6/21 at home.
Patient received a dose of Pfizer COVID-19Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
Adult received  pediatric dose of Havrix; Adult received  pediatric dose of Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 44-year-old female patient who received HAV (Havrix 720) (batch number T57F3, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th November 2022, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 15th November 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-NOV-2022. Reporter's Comment: The pharmacist reported that an adult patient received a pediatric dose of Havrix.  The reporter gave consent to follow up. Additional Supportive Information: The adult patient received a pediatric dose of Havrix, which led to adult use of a child product and underdose.
Swelling whole right arm (from upper arm to wrist) after 24 hours of Anthrax shot (second dose of Anthrax). Treated with Motrin. Had slight nausea, generalized weakness and joint pain. Today (on the 5th day), it is still swelling with redness present at right arm.
It felt like a flu. Difficulty breathing and fatigue. My partner got very sick but I am the caregiver so I contracted from her. I called my doctor office but I decided to forego the PAXLOVID and tough it out.
pt recv vax 29JUN98 & devel abd cramps, nausea, diarrhea, swelling under both axillae & pain running down the inside of the arms to the palms of hands;swelling & pain alternated @ times from one arm to the next;
Muscle twitching, lost balance and fell in the bathroom and couldn't get up for 15 minutes, extremely dry mouth, stated he kept feeling like his body was "pulling to the right".
This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB which had Lot number M036153 with expiry date on 31-MAY-2018 and lot # M029233 with expiry date on 09-AUG-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of > 8 but <25 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008046: US-009507513-1703USA008047: US-009507513-1703USA008048: US-009507513-1703USA008049: US-009507513-1703USA008051: US-009507513-1703USA008052: US-009507513-1703USA001827.
Red hot lt knee & lower thigh, tender to touch, t98.8 occurred p/3 hrs; resolving @ approx 30 hrs;
Information has been received from a registered nurse regarding a 13 year old patient of unknown gender. The patient´s medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of VARIVAX subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The VARIVAX was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013248: US-009507513-1710USA013249: US-009507513-1710USA013250: US-009507513-1710USA013251: US-009507513-1710USA013252: US-009507513-1710USA001718.
Myocarditis; elevated cardiac troponin T; This is a literature report for the following literature source(s):   An adolescent patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown"; TROPONIN T INCREASED (hospitalization), outcome "unknown", described as "elevated cardiac troponin T". The patient underwent the following laboratory tests and procedures: Antibody test: asymptomatic, notes: Results were compared with those from 45 healthy, asymptomatic, age-matched vaccinated control subjects; Cytokine test: asymptomatic, notes: Results were compared with those from 45 healthy, asymptomatic, age-matched vaccinated control subjects; SARS-CoV-2-specific T-cell analysis: asymptomatic, notes: Results were compared with those from 45 healthy, asymptomatic, age-matched vaccinated control subjects; Troponin T: increased, notes: (median, 260 ng/L; interquartile range, 215-1114 ng/L; upper limit of normal, 14 ng/L) and C-reactive protein (CRP) levels (median, 29.75 mg/L; interquartile range, 15.53-50.58 mg/L; upper limit of normal, 8 mg/L).  Clinical information: Additional information: Vaccinated control (n=44) and myocarditis (n=16) cohorts. Antigen data corresponding to all individuals who received the BNT162b2 vaccine (n=59) and those who received the Moderna vaccine (n=2). Postvaccine myocarditis (n=16): Age at enrollment, average (minimum, maximum), y: 16 (12, 21) Male, n (%) 13 (81). Our cohorts were not evenly balanced between the BNT162b2 and mRNA-1273 vaccines: all of our adolescent control cohort and the majority of our myocarditis cohort received the BNT162b2 vaccine (n=15). In the postvaccine myocarditis cohort, most of the individuals (n=12 of 16; 75%) developed myocarditis after the second dose, although 2 experienced symptoms of myocarditis after the first dose and 2 after the third booster dose. All patients presented with chest pain, and all were found to have elevated cardiac troponin T (median, 260 ng/L; interquartile range, 215-1114 ng/L; upper limit of normal, 14 ng/L) and C-reactive protein (CRP) levels (median, 29.75 mg/L; interquartile range, 15.53-50.58 mg/L; upper limit of normal, 8 mg/L). Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
no additional AE's noted; temperature excursion; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2021, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T003017, expiration date 25-JUL-2021 (formulation, route of administration, strength and dose were not reported) for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at 8.8 Fahrenheit degrees (F) for 45 minutes. There was previous temperature excursion at 8.71 F for 15 minutes. The call was due to digital data logger. No additional adverse event was reported.
Patient was given an adult dose of Hepatitis A vaccine. No adverse reactions have arisen due to giving the vaccine.
Anaphylaxis approximately 20 minutes after dose.  Patient reported throat closing, flushing, and diaphoresis.  Epi 0.3 mg IM given x 1 with resolution of skin symptoms, but no improvement in throat.  Benadryl 50 mg IM x 1 given enroute to ER.
Initial report was received on 15 May 2012 from a consumer, who is also the patient. A 36 year-old male patient with a history of seasonal allergies had received on 20 January 2012, an intramuscular left deltoid injection of FLUZONE (lot number not reported) and an unspecified amount of time later the day of vaccination, the patient began to feel "out of sorts, not himself". Later the same night, the patient experienced extreme itching (with no rash noted), headaches, reflux, blurred vision in both eyes, his body was "sore" and felt like he had been "hit by a truck". The patient vomited, his eyes "hurt" and he had tingling in his hands and feet. The symptoms continued to worsen over the next few weeks. The patient experienced an increased heart rate and was diagnosed with tachycardia. The patient was evaluated in the emergency room (ER) on four occasions for excessive headache, tingling in the arms and legs, racing heart, palpitations, and fainting. The patient was diagnosed with an autoimmune reaction and stated the symptoms were not improving. The patient developed a clear film over his left eye and had been evaluated by an ophthalmologist. The patient also reported pain "similar to a charlie horse" in both arms, but more prominent in the left deltoid. The patient stated he was tired all the time and does not have any energy. The patient reported that he "was so distraught over the change in his health he contemplated suicide". Treatment included TAMIFLU with no improvement. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Information has been received from a consumer concerning her 19 weeks old son who on an unspecified date was vaccinated with ROTATEQ (Lot number was not provided) at 19 weeks old.  No adverse effects were reported.  No further information is available.
I started feeling mild symptoms about 12/11/2022 I had a runny nose, sinus congestion, sore throat and coughing.