chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of hive in a 65-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure, high pressure in eye, sulfa allergy and tomato allergy. Concurrent medications included lisinopril and XALATAN. On 9 October 2012 at 10:30 the subject received 1st dose of FLULAVAL (unknown, left arm). On 12 October 2012, 3 days after vaccination with FLULAVAL, the subject experienced hives, bruising and dry skin. The subject reported that she was taking BENADRYL to help with her hives. The subject reported that she received the injection at her place of employment, but planned to follow-up with her own physician on an unknown date. The hives resolved on 12 October 2012 and the dry skin resolved on 15 October 2012. At the time of reporting the bruising had improved.
Low grade fever (99.2); Fatigue; Joint pain; Hot flash; Dizzy; Blurred vision; Heart palpitations; Mild confusion; Forgetfulness; Injection site pain; Intermittent burning and stinging of skin in various locations; Intermittent burning and stinging of skin in various locations; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 19Mar2021 at 10:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, right bundle branch block, premature ventricular contractions, gout, osteoarthritis, fibromyalgia, depression and anxiety. The patient was allergic to ultram, tramadol, pseudoephedrine, sensitive to NSAIDs and sensitive to morphine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 19Mar2021 at 10:05, first 5 min, the patient experienced with hot flash, dizzy, blurred vision and heart palpitations. The patient felt fine. On an unknown date in Mar2021, the patient had two days of mild confusion, forgetfulness, injection site pain (for 10 days limited ROM), intermittent burning and stinging of skin in various locations. On 23Mar2021, on day 4, the patient experienced fatigue and joint pain. On 29Mar2021, day 10, the patient had low grade fever (99.2). The events did worsen each day peaking day 12 on 31Mar2021 and mild improvement on day 13 on 01Apr2021 and on day 14 on 02Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 29Mar2021, the patient underwent lab test which included body temperature test which measured low grade fever (99.2). Therapeutic measures were not taken as a result of events. The clinical outcome of events hot flash, dizzy, blurred vision, heart palpitations, mild confusion, forgetfulness, injection site pain, intermittent burning, stinging of skin, fatigue, joint pain and low-grade fever (99.2) were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Painful arthritis in left hand; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 29Mar2021 at 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the right arm on 01Mar2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 05Apr2021 at 00:00, the patient experienced painful arthritis in left hand, that he never had before. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event painful arthritis in left hand was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient and Mom here to report increased symptoms to right thigh, and increased red with splotches - swollen - very firm, hot to touch and hurts.  Prescription for Atarax, Motrin, ice and heat packs.
Child has redness on both sites, received Tdap #5 and MCV4 on 7/31/13. Warm to touch. Childs appetite good, no breathing distress. Follow up: patient came back after 2 days swelling gone down pt doing very well.
Patient possibly received only the diluent component of Priorix; Patient possibly received only the diluent component of Priorix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Patient possibly received only the diluent component of Priorix) and inappropriate dose of vaccine administered (Verbatim: Patient possibly received only the diluent component of Priorix).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 30-AUG-2023 The reporter was a medical assistant. The reporter reported that the patient possibly received only the diluent component of Priorix which led to, inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not provided any details about patient and stated that paperwork was not available at the moment of the call. The reporter consented to follow up.
27jul90 pt vax hepta B. pt ex flu like illness w/ sore throat, muscle aches, and some soreness at inject site. 3 weeks aft vax pt devel diarrhea.  pt tx w/ pres. drugs.
Rec'd Dtap and IPV. 11/01/04. Had a localized maculopapular rash on bilateral lateral aspect of thighs. Has had a similar reaction previously. F/U vaccine hotline: Localized reaction not a contraindication to further immunizations, no systemic reactions.
RECEIVED VARIVAX VACCINE IN THE AM AND STARTED DEVELOPING RASH THAT EVENING TO UPPER BODY.  ITCHY AND TURNING INTO OPEN SCABS.  SEEN IN OFFICE 7/28/2010 AND RX ZOVIRAX, BACTRABAN, AND BACTRIM.  8/3/10 PER RECPTIONIST RASH IS DRYING UP AND RESOLVING.
vaccine info unknown patient with hx of itp resolved 9 years ago. developed very minor petechiae and headache
pt recv vax & the next day pt exp an inj site rxn, characterized by large areas of inflammation from the inj site to the shoulder & into the chest area;the rxn lasted several days;this is one of three patients from this site to report AE
One week after immunization patient developed a large red hive at injection site. Size is 2 in x 4 in.
No addtitional adverse effect reported.; the patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT).  On 16-DEC-2019, the patient was inadvertently administered a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose and route of administration were not reported) (lot # S021926, expiry date 15-JUL-2021) for prophylaxis. Storage temperature was 1.2 Celsius degrees (C) during the time frame of 3 hours 9 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect was reported.
This spontaneous report was received from a registered nurse and refers to a 17-year-old male patient with attention deficit disorder with hyperactivity (ADHD). On 11-OCT-2012, the patient received first dose of GARDASIL (dose, route of administration, lot# and expiration dates were not reported). On 30-NOV-2012, and subsequently 01-APR-2013, the patient was vaccinated with a second and third dose of GARDASIL (dose, route of administration, lot# and expiration dates were not reported). On an unknown date, the patient was vaccinated with GARDASIL 9, for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On 08-NOV-2017, the patient was vaccinated with of GARDASIL 9, 1 dose, intramuscularly in right deltoid, lot# reported as N021733 for prophylaxis (expiration date was not reported) and first dose of BEXSERO 1 dose, intramuscularly in left deltoid batch# 16Btd at private doctor's office/ hospital. The vaccines was purchased with private funds. Concomitant therapies included propranolol and atomoxetine hydrochloride (STRATTERA). On 11-OCT-2017, the patient developed a fever of unknown temperature. The patient did not have prescribe any treatment for the event. The patient recovered form the event on an unknown date in approximately November 2017. The relatedness between th events and suspect vaccines was not reported.
Day after administration: headache, fever of 101+, malaise. 2 days after administration to 4 days after administration: daily migraine
Information has been received from a physician concerning an 18 year old female who on 19-JAN-1998 was vaccinated with the first dose of VARIVAX (Merck). On 03-JUL-2008 at 11:00 AM the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot no. 659935/1900U) into the right arm. At the same time the patient was vaccinated with HPV (MSD), MENACTRA and Tdap. Concomitant therapy included MIRALAX. On 18-JUL-2008 the patient experienced rash. On 21-JUL-2008 the patient was examined in clinic. The patient had no fever. The patient had vesicular and papulovesicular lesions everywhere on scalp, face, trunk and extremities and pruritus. The patient was treated with VALTREX and antihistamines for for pruritus. On 25-JUL-2008 the patient was followed up by phone. The lesions were crusted. No new lesions and no fever. Additional information is not expected.
Pt developed Varicella (Chickenpox) after receiving the vaccine, pt developed fever 102 and and rash first appeared on Right leg.
fever-APAP; induration-4x6cm; pruritic papular rash;
7x8cm Redness, mild swelling and non tender. Impression, vaccine reaction-local allergic. Probably DTaP
pain at the injections site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on an unknown date, refer case US2022060339).   On 4th April 2022, the patient received the 2nd dose of Shingrix. On 5th April 2022, 1 days after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022060339   Additional Information: GSK Receipt Date: 05-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received second dose of Shingrix vaccine yesterday (day before reporting) and was now experiencing pain at the injections. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022060339:Same patient/reporter
pt said she had hallucinations Wed night or Thurs am (not sure).  Also,  pt developing bruises on lower extremities.  Sounds like it started on one side then next day more on other side.  Pt did call md and waiting for a call back.  I recommended she get a hold of her md somehow to see if she should get checked out.  I am thinking bloodwork may need to be done to check platelets (just my own guess).
Confirmed case of measles, H2d classic clinical presentation followed by confirmatory buccal swab. PCR confirmed vaccine related, not wild type.
This case was reported by a other health professional via sales rep and described the occurrence of localized erythema in a 12-year-old male patient who received MENVEO. On 24th July 2017, the patient received the 1st dose of MENVEO. On an unknown date, less than a month after receiving MENVEO, the patient experienced localized erythema (serious criteria clinically significant/intervention required) and swollen joints (serious criteria clinically significant/intervention required). The patient was treated with antibodies NOS and antihistamine. On an unknown date, the outcome of the localized erythema and swollen joints were not reported. It was unknown if the reporter considered the localized erythema and swollen joints to be related to MENVEO. Additional details were provided as follows: This case was reported by the office manager. In 2017, the patient developed a red and swollen area on the shoulder after receiving MENVEO vaccine. The swelling was severe enough that antibiotics and perhaps antihistamine were given. Other seriousness criteria (death, hospitalization, disabling, congenital anomaly, and life-threatening) were not associated with the reported events.
Intermittent paralyzed left side; Hives; itching; Redness; Shortness of breath; A spontaneous report was received from a nurse who was also a 70-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed left sided paralysis, shortness of breath, hives, itching, and redness.  The patient's medical history included asthma. Products known to have been used by the patient, within two weeks prior to the event, included albuterol sulfate, epinephrine and diphenhydramine.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 075T202A) intramuscularly for prophylaxis of COVID-19 infection.     On 05 Jan 2021, after receiving the vaccine the patient developed redness, itching and shortness of breath. On 06 Jan 2021, she developed hives and was paralyzed after sleeping. She experienced paralysis on the left side and her right side felt heavy. Treatment for the events included diphenhydramine, epinephrine, and albuterol.  Action taken with the second dose of mRNA-1273 in response to the events was not provided.    The events, paralysis on the left side and hives, was considered resolved on 07 Jan 2021. The events, redness, itching and shortness of breath, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 70 year old, female patient, with a medical history of asthma, who experienced a serious unexpected event of hemiplegia, a non-serious unexpected event of dyspnoea, urticaria, pruritus and a non-serious expected event of erythema. The event of dyspnoea, pruritus, and erythema occurred 1 day after first dose mRNA-1273 (Lot# 075T202A) administration. The event of hemiplegia and urticaria occurred 3 days after first dose mRNA-1273 (Lot# 075T202A) administration. Both concomitant and treatment medications included Benadryl, Primatene mist and albuterol. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
PT. RCV'D 2ND HPV AND 2ND HEP A VACCINE.  HEP A WAS ADMINISTERED FIRST ON RD.  THEN HPV ADMINISTERED TO LD. PT. WAS TO WAIT IN THE ROOM FOR PRINT OUT.  CAME OUT TO WAITING ROOM. PROCEEDED TO FAINT.
Act-Hib exposed to 34.5 degrees Fahrenheit for 40 minutes was given to a patient with no AE; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographics patient who received a dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot: UJ144AAA, expiry date: 22-Mar-2021), via an unknown route and site, on an unknown date for prophylactic vaccination (product storage error).  The patient's medical history, medical treatments, concomitant medication, vaccinations and family history were not provided.  It was a case of an actual medication error due to product storage error temperature too low. It was reported that the Act-Hib exposed to 34.5 degrees Fahrenheit for 40 minutes which was given to a patient.  Reason for excursion was the temperature monitoring probe inside the fridge was displaced and they had to move it behind the fridge so that it can regulate temperature.  At the time of reporting, the patient had no adverse event.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Bells Palsy symptoms, visited doctor Feb. 23rd, prescribed prednisone for 5 days
I have had almost daily headaches starting in July 2021.  I have never had chronic headaches before getting the vaccine.
let out a cry when she got her shot;  Little betterstill can't tell what was wrong Felt deeper than muscle pain; didn't feel like flu Yelled out when she got the shot; very painful for 2 weeks Has 2 small kidshard to pick them up; couldn't undo her bracouldn't move arms Pain: 7/10--at the worst Now: 3/10 A dull ache; don't like taking advil: takes Tylenol; dealing with itnon dominant hand There were others with intense pain for several days;  It was an aggressive motion as she gave the injection; there was something about her ??? was it something to do with how she put the needle in the arm
It triggered shingles. Itchy very painful viral infection on my right neck/face/back/shoulder area. I am currentlu on Valacyclovir 1gm and managing the symtoms with topical.
I tested positive for COVID on 01/21/2022. Once I turned positive, my husband and son went to urgent care and got tested. My son tested positive and my husband was negative. A couple of days later my husband tested positive. I had a scratchy throat and orbital pain like having a sinus cold or infection. I went to urgent care the next morning and they gave me 2 shots and a cough syrup. I have had tinnitus for years and I noticed since I recovered from COVID, my tinnitus has been more noticeable than before. About 3 weeks later I started having vertigo. I went to the emergency room and they gave me a medication. They did some balance tests and lab work, which came back normal. The tinnitus is still there. I got a referral with an audiologist and I just saw them last week.
Besides the usual body aches and body chills, I also developed sinus pressure, chest pressure, and a very mild cough.
36 hours after vaccination was received, I woke with painful stiffness on left side of neck and back of head. Swollen occipital lymph node on left side. As time progressed, pain spread across scalp and neck. Swelling and pain followed. I went to visit my primary care physician today (Monday, March 1st) and was diagnosed with SHINGLES.
Patient ran fever of 104 degrees off & on x 3 days, lethargic - treated with TYLENOL & MOTRIN to reduce fever.
After receiving vaccination, approximately 2 minutes after - patient lost color, fainted, and began to seize. 911 was called, EMT took vitals and blood pressure was low. Patient refused to go to emergency room. Patient sat for about 20 minutes after shot, he was asked multiple times if he was okay to drive and he said yes.
Pt stated she was nauscous after vaccine. Nausea with vomiting one time at 11:25 after first dose Pfizer.  Objective: Check VS at  1130: AAOx4,sitting up,no diaphoresis. NAD, O2 98% on RA, HR 92, T:98.No pain. Denies SOB, itchiness, difficulty breathing.No medications administered. Pt declined and stated already felt better after throwing up. Intervention: Encouraged fluids:Drank 8oz water H20 and monitored.  1135: AAOx4 pt stated symptoms resolved.  1145: AAOx4 sitting up, NAD,BP:115/59 HR:77BPM O2 Sat: 100% on RA, Temp 98.2 F, No pain. No medications administered. All symptoms resolved.Denies SOB, itchiness, difficulty breathing, nausea.  11:50 AAOx4 sitting up NAD.Encouraged fluids:Drank 120ml water.  1200: AAOx4 sitting up NAD VS: BP:118/99 HR:99 Os Sat 97% on RA. No pain. Denies SOB, dizziness, difficulty breeathing, itchiness.  Pt able to ambulate unassistated. Walked to car.Pt not driver. Strict ED precautions if difficulty breathing, SOB, dizziness. Instructed pt to pt follow-up with PCP within 24 hours.Pt verbalized understanding. All questions addressed.
Swelling to left arm at injection site within 24hrs. (+) erythema that involved entire length of arm. No fever, mild tenderness.
On 01/26/21, 67 yo F with anemia, asthma, Afib (on rivaroxaban), fibromyalgia, DM2, HLD, and osteoarthritis was administered COVID-19 Moderna vaccine 0.5 mL in left deltoid (Lot #011J20A, Exp: 05/11/21). Pt has numerous documented allergies including iodine (hives, facial swelling), Shellfish Containing Products (Hives, facial swelling) and penicillin (edema). Pt initially tolerated injection without incident and was sent for post-injection observation. Within 10 minutes, pt developed acute SOB, increased WOB, wheezing, and cough. Pt also reported itching skin and scratchy throat. Provider notified and exam found pt in respiratory distress with increased work of breathing, bronchospasm and wheezing. Pt had no rash, lip swelling or vomiting. Vitals assessed as O2 sats >96%, BP 140-150s/60s, HR 70-80s. Pt was administered albuterol 2.5 mg via nebulization x 2, diphenhydramine 50 mg IM and epinephrine 0.3 mg IM. Pt was subsequently transported to ED. By time of arrival, pt's symptoms had significantly improved. Pt administered famotidine 20 mg IV and prednisone 60 mg PO and placed on continuous cardiac and pulse oximetry monitoring. After complete symptom resolution, pt was discharged in stable condition. Pt's allergy profile was updated to include Moderna Covid-19 Vaccine (eua) (rxn: Anaphylaxis; severity: High).
This spontaneous report was received from a medical assistant refers to a 12 year old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 20-NOV-2015 (reported as "when the patient was 11 years old"), the patient was vaccinated with first dose of GARDASIL 9 for prophylaxis (lot #, expiry date, dose, strength, vaccination site, route not provided). The reporter stated that, on 29-NOV-2016 (reported as "today"), the patient was seen in the office to receive his second dose of GARDASIL 9 and was administered (lot #, expiry date, dose, strength, vaccination site, route not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. Additional information has been requested.