chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives; itching all over her chest, back, arms, legs, feet, everywhere; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and PRURITUS (itching all over her chest, back, arms, legs, feet, everywhere) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced URTICARIA (hives) and PRURITUS (itching all over her chest, back, arms, legs, feet, everywhere). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) and PRURITUS (itching all over her chest, back, arms, legs, feet, everywhere) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter.
Information has been received from a physician via a company representative referring to a male patient of unknown age. There was no medical history or drug reaction/allergies reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, dose and lot# were unknown). No concomitant therapy was reported. On an unknown date the patient experienced hearing loss after receiving the ZOSTAVAX vaccine injection. The patient contacted the physician for medical attention and was not hospitalized. At the time of reporting, the outcome of the event was unknown. Causality was not provided. Upon internal review, the event "hearing loss" was considered as medically significant. Additional information has been requested.
Child had a 6" x 4" discoloration on R leg, induration of 2" surrounding injection site and the rest was redness.  Immunizations given on 4-2-08, on 4-3-08 redness was quarter sized, on 4-4-08 had gotten bigger.  Milder, Augmentin, Prelone.  No fever.
This non-serious initial spontaneous case, was received from pharmacist on 07-SEP-2017, concerning a male patient of an unspecified age. On an unspecified date, the patient was administered with influenza vaccine (dose: batch number, manufacturer, trade name, route of administration, anatomical location: not reported). On an unspecified date, the patient reported that, he did not get the full dose of the vaccine because nurse administered the vaccine very fast, which looked that vaccine was not injected. The patient felt that, the vaccine came out of his arm and he did not feel his arm sore. At the time of this report, the outcome of the events was not reported.
Systemic: Fainting / Unresponsive-Medium, Additional Details: pt fainted approximately 30 seconds after receiving vaccination. Patient was seated but hit is neck on the arm of the chair. He also hit his head on the wall located next to the chair where patient was seated. Blood pressure was taken- 116/68  pulse 78
Extreme ringing in my ears and head.; Heart palpitations (beating hard, not rapid) I could hear my heartbeat in my ears.; Dose number 3; This is a spontaneous report received from a contactable consumer. The reporter is the patient.   A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 03Jan2022 at 19:00 (Lot number: 3313088) at the age of 53 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing), notes: I have a hx of Tinnitus; "Fruit allergy" (unspecified if ongoing), notes: Known allergies: Avocado and "Allergy to plants" (unspecified if ongoing), notes: Known allergies: Dill. Concomitant medication included: IRBESARTAN/HCTZ. Past drug history included: Bactrim, reactions: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number- EW0162, Route of Administration: Unspecified, Anatomical site: Left arm), administration date: 22May2021, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number- EW0217, Route of Administration: Unspecified, Anatomical site: Left arm), administration date: 12Jun2021, when the patient was 52 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 03Jan2022 at 19:00, outcome "unknown", described as "Dose number 3"; TINNITUS (non-serious) with onset 03Jan2022 at 22:00, outcome "not recovered", described as "Extreme ringing in my ears and head"; PALPITATIONS (non-serious) with onset 03Jan2022 at 22:00, outcome "not recovered", described as "Heart palpitations (beating hard, not rapid) I could hear my heartbeat in my ears". Therapeutic measures were not taken as a result of tinnitus and palpitations.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
SHORTNESS OF BREATH; CONGESTION; SORE THROAT; RUNNY NOSE; VOMITING; DIARRHEA; COUGH; CHILLS; LEFT ARM PAIN; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. 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) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-JUL-2021, the subject experienced shortness of breath. On 10-JUL-2021, the subject experienced congestion. On 10-JUL-2021, the subject experienced sore throat. On 10-JUL-2021, the subject experienced runny nose. On 10-JUL-2021, the subject experienced vomiting. On 10-JUL-2021, the subject experienced diarrhea. On 10-JUL-2021, the subject experienced cough. On 10-JUL-2021, the subject experienced chills. On 10-JUL-2021, the subject experienced left arm pain. On 10-JUL-2021, the subject experienced nausea. On 10-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, cough, shortness of breath, nausea, vomiting, diarrhea, headache, runny nose, congestion, left arm pain, and sore throat. This report was non-serious.
MODERNA VACCINE GIVEN TO 17 YEAR OLD. MEDICATION ERROR BEING REPORTED AS VAERS.
PT STATED THAT ON FRIDAY HER ARM STARTED TO GET SORE, RED, AND SLIGHTLY SORE, LYMPH NODES UNDER ARM SWOLLEN AND TENDER.  REDNESS AND TENDERNESS LASTED ABOUT 3-4 DAYS TOTAL.  PT TOOK BENADRYL UNDER ADVICE OF NURSE THAT WORKED FOR DOCTORS OFFICE.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, 1 in total, start therapy date were not reported, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was not developed antibodies (coded as suspected immunological vaccine failure). Laboratory data (dates unspecified) included: COVID-19 antibody test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210520747-covid-19 vaccine ad26.cov2.s-Suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I received my 2nd dose of the Pfizer vaccination at about noon on Tuesday  May 4. I went about my normal business during the day - did some errands, had a personal training session, bought groceries, and cooked dinner. I experienced a little dizziness in the hours after the injection and during the day, but nothing too disturbing. When I sat down for dinner around 8 or 9pm, I had a few sips of wine - maybe 3 ounces at most - and I immediately had a very hot feeling in my head and started hearing my heart pounding in my ears. I stopped drinking and just had dinner, and as the night progressed, I felt extremely uncomfortable. My chest felt very tight, like it was being squeezed from the inside; I had a pounding heart; my pulse was very fast; I felt very hot; and I had some difficulty breathing deeply. I also felt very agitated and not sleepy - as if I had consumed an overdose of caffeine. I watched TV until 1:30am, and I was awake in bed for several hours after that just trying to practice deep breathing and meditation. I fell asleep at some point in the early morning and woke up around 9am. By then the troubling symptoms had passed, and I was just feeling achy and extremely exhausted.
No additional AE information provided.; HCP called to inquire if a PROQUAD dose (first dose) that was administered to 16 year-old female patient on 2/9/2022 is a valid dose.; This spontaneous report was received from a registered nurse, referring to a 16-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-FEB-2022, the patient was vaccinated with the first dose of measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) (valid lot #U024507, expiration date: 02-FEB-2023, therapy type: rHA) (strength, dose, route of administration and anatomical location were not provided) (product administered to patient of inappropriate age) for prophylaxis. No additional adverse event was reported.
Stated, "Arm is sore to touch, there is a knot at the injection site and I just don't feel good."  Denies any warmness to touch or fever. On day of vaccine administration. Encouraged to use cool compresses and take Motrin.   2nd day, Client stated, " I feel nauseous, area is warm to touch, but no redness."  Has been applying cool compresses and taking motrin.  Denies any fever.  Has scheduled appt with PMD for 5/10/2019. 3rd day, Client states, "Is feeling better.  Arm is still tender, but no redness, swelling or warmness to touch.   Denies any fever. Has continued with the cool compresses and Motrin today.  Was seen by Dr. today, his office stated, "She had an adverse reaction.  Was given Depo Medrol and Decadron in right deltoid.  Area was warm to touch.  No redness noted.  Afebrile."
Information has been received from a physician concerning a teenage female who within the last two years (approximately 2007) was vaccinated IM with a dose of GARDASIL (route in the series and lot number unspecified).  The physician reported that the patient "fainted" after getting the vaccine.  The outcome of the patient was recovered.  The patient sought unspecified medical attention.  This is one of two reports from the same source.  Additional information has been requested.
SOTES AND BLISTERS ON LEFT SIDE OF FACE, CONTINUING FOR 6 WEEKS
About 1 o'clock the same day as the vaccine 02/21 I started experiencing low blood sugar. Around 50-55 I have a blood sugar monitoring device implanted into my arm. I knew immediately that I had low blood sugar and no matter how many sugary drinks and things I consumed. I sat below 60 for 10 hours. I felt like I needed to drink a lot of juice and eat a lot of sugary foods just to remain below 60. I'm usually able to maintain my blood sugar level by diet but this time it was very difficult. I messaged my endocrinologist and explained what was going on and she had recommended various high sugar food and juices. She recommended if I wasn't able to maintain a good blood sugar level that I should go to the ER. Luckily I was able to maintain it and after 10 hours it was back to normal, it was rather odd.
About 34 hours after receiving the vaccine I started with severe stomach pain followed by vomiting every 20-40 min until 8:30 am; Following the vomiting I was still incredibly nauseous and still have intermittent stomach pain. I have NEVER had a vomiting episode like that ever in my life. I called my PCP at 8am and asked for a prescription for an anti-nausea medication which I have taken 5 doses of since receiving on 01/5/2021 at 12:00 PM. I'd like to state that other then going to receive my vaccine I have not been around anyone to have gotten a stomach bug. My husband whom I live with did not start throwing up either so I don't think it was anything I could have passed to him. I don't know that this was caused by the vaccine however I did want to report it incase. I am having the 2nd dose on 2/1/2021.
Pt reported that night arm swelling from shoulder to neck with fever. Trip to Urgent Care Clinic, received steroid shot and MEDROL DOSEPAK.
hot around the injection site; it feels hard-some; itchy around the injection site; red spot around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE INDURATION (it feels hard-some), VACCINATION SITE PRURITUS (itchy around the injection site) and VACCINATION SITE ERYTHEMA (red spot around the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B321A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), HYDROCHLOROTHIAZIDE, ALPRAZOLAM (XANAX), PROPRANOLOL, CLONIDINE HCL, ATORVASTATIN CALCIUM (LIPITOR), METFORMIN HCL and VITAMINS NOS for an unknown indication.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE INDURATION (it feels hard-some), VACCINATION SITE PRURITUS (itchy around the injection site) and VACCINATION SITE ERYTHEMA (red spot around the injection site). The patient was treated with IBUPROFEN for Arthritis, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE INDURATION (it feels hard-some), VACCINATION SITE PRURITUS (itchy around the injection site) and VACCINATION SITE ERYTHEMA (red spot around the injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient also took ginger tablets as concomitant medication. Treatment with rubbing alcohol for the itching part at the site of the injection ibuprofen, were provided.
patient received pentacel vaccine which was forzen/No AE; Initial information was received on 19-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to cases 2020SA133785, 2020SA133715, 2020SA133786 and 2020SA133787 (same reporter)  This case involves a six-months-old patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]] which was frozen (incorrect product storage).  Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage as patent received a dose of frozen Pentacel.  At the time of report, no adverse event was 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 Directive and Module VI of the Practices. 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.  There will be no information available on the batch number for this case.
Information has been received from a physician concerning an 82 year old male with hypertension, high cholesterol and a childhood history of chickenpox who on 14-JAN-2008 was vaccinated into the left arm with a "single dose" of ZOSTAVAX (lot# 658210/1079U).  On 21-JAN-2008 the patient developed vesicles at "L C/2 C2", also reported as shingles on his left shoulder, upper arm and neck.  It was noted that a rash did not occur at the injection site or elsewhere within 42 days of the vaccination.  The patient was treated with acyclovir and lidocaine (LIDODERM).  It was reported that the vesicles remained for ten (plus) days.  The patients symptoms included generalized aching with pain "in the region".  It was noted that the patient had not had any recent exposure to chickenpox or herpes zoster.  A direct fluorescent antibody was not done, nor was a specimen collected for VZV identification.  Unspecified medical attention was sought.  There was no product quality complaint.  There were no lab diagnostic studies performed.  At the time of reporting it was noted that the patient had partially recovered, with pain and neuralgia persisting, along with severe hyperesthesia.  The event of shingles was considered to be disabling by the reporter given that "the patient is in pain".  The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain.  Additional information has been requested.
Noticed lt testicle swollen in AM p/receiving immun previous day; referred to MD;
Got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got Covid) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A3716313) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 1, Batch/Lot No.: EL3247) on 30-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 2 and Batch/Lot No.: EL3247) on 21-Apr-2021. Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 01-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jul-2023, the patient experienced COVID-19 (Got Covid). At the time of the report, COVID-19 (Got Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2023, SARS-CoV-2 test: (Positive) Nasal Swab.         Concomitant medication information was not provided.  The patient received third dose of Moderna vaccine (having lot no. 060H21A) on 11-Dec-2021.  Treatment information was not reported.
Two weeks after shot, pain started in feet. Waking me up 2 times a night and worked into pain all the time. Mainly in left leg to upper leg and right leg. Pain got intense. Took time to find out what was wrong. (Steroids - Lumbar Puncture.) Per annual report-Peripheral neuroopathy, RSD, numbness, weakness and pain   Nurse follow up on 08/19/04 states: "cramps in thighs; numbness; weakness; thorasic myelopathy;
Information has been received from a Registered Nurse (R.N.) concerning a 32 year old female patient with allergy to promethazine with codeine and history of migraine who on an unspecified date, in the past, was vaccinated with a dose of MMR II.  Concomitant therapy included LEXAPRO and LOESTRIN.  It was reported that the patient had negative titers for rubella.  The patient sought unspecified medical attention.  The office did not have the patient's immunization records so she did not know if the patient had received 1 or 2 doses of MMR II.  At the time of the report the patient had negative titers for rubella.  Follow up information has been received from a registered nurse who stated she spoke with the 32 year old female and she did not have any adverse reaction to MMR II.  Additional information is not expected.
Booster symptoms prolonged for 72 hours at moderate to strong intensity. High fever and unusual symptoms like feeling "stiff as a board," abdominal pain, a ring rash in the armpit area, sensitivity to light, and chest pain. Did not have this reaction to the second shot in April 2021. Doctor recommended reporting my reaction. Shot received Saturday 18th at 6 pm. Immediately felt "out of body," as if sickness was coming on, along with a minor headache. Sunday, 19th starting at 1 am: Fever got up to 103, took 1 Tylenol (3-4 over the day) and got the fever down to 100.5/101 range, but then went back up after Tylenol wore off. "Stiff as a board" very stiff throughout body, especially first 12 hours. Hard to stretch or move. Painful to get up and go to the restroom. Very severe headache and sensitivity to light for about 36 hours. Confused, could not think. Abdominal pain, front and back. Around the hip area. Lymph nodes hurt and were like balloons. Limited movement of arm for ~72 hours. No appetite. Monday 20th: Fever got up to 101.7, took 1 Tylenol (3 over the day) to got fever down to 100.1 Ring rash under each armpit. Shortness of breath. Chest pain and tightness. Headache, less severe. Neck pain and limited neck motion. Muscle aches, less stiff. Limited appetite. Tuesday 21 and Wednesday 22nd: Got fever down to normal range by the middle of the day Tuesday. Everything else normal besides slight headache, fatigue and muscle aches. Thursday the 23rd: Normal.
PATIENT REPORTS PAIN AT TIME OF INJECTION AND HAS CONTINUED SINCE. PAIN RATED AT 8 OR 9 OUT OF 10 WHEN LEFT ARM IS LIFTED TO HORIZONTAL POSITION. AT REST PATIENT REPORTS NO PAIN EXCEPT SOMETIMES.
Patient presented with chest tightness and SOB. Patient fully vaccinated and resulted positive for COVID.
pt recv vax 3OCT97 & that same day pt exp h/a & flu sx consisting of congestion, backache, sinus congestion & pain;pt keeps returning to the MD office w/these complaints & the reporting MD feels that they are r/t a cold & poss sinus infect;
pt got 1st covid vaccine on 5/4/21 and developed swallowing difficulites.  Felt flushed and had a sore throat.  Complained of swelling in throat.  Pt taken to ED. 48-year-old female presents from vaccine clinic with concerns about possible allergic reaction. No urticaria, no wheezing, no angioedema. Does have occasional bronchospastic cough. Patient reports she gets this with involved but felt a little bit of throat tightening and was worried she could be having an allergic reaction. Received Benadryl and Decadron here, reports that she would like to go home at this point in time, does not want to try albuterol that was ordered, will take over-the-counter allergy medicine as needed and return for any worsening. Unclear if this is truly an allergic reaction, patient advised that she still should get the second shot and be monitored closely.