chrisvoncsefalvay/vaers-outcomes huggingface dataset:
serum sickness; headache; puffy face; puffy eyes; nausea; fever; achy joints; bronchitis; Initial information was received on 19-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 70-year-old female patient who had serum sickness, headache, puffy face (swelling face), puffy eyes (periorbital swelling), nausea, fever (pyrexia), achy joints (arthralgia) and bronchitis, while she received INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious serum sickness, headache, puffy face (swelling face), puffy eyes (periorbital swelling), nausea, fever (pyrexia), achy joints (arthralgia) and bronchitis (unknown latency) following the administration of INFLUENZA VACCINE.  The patient was in bed for almost two weeks.  The patient wanted to get the Pfizer (coronavirus disease of 2019) Covid 19 vaccine. She did not know if there was a specific component of the influenza vaccine that caused her reaction. She knows of other people who had serious vaccination problems with the pneumonia vaccine who received the Moderna Covid 19 vaccine with no issues. She was concerned she might have a serum sickness with the Pfizer Covid 19 vaccine.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for all the events.  There will be no information available on batch number for this case.
itchy red spots anywhere across the body at one or two places at a time; itchy red spots anywhere across the body at one or two places at a time; sometimes accompanied with hives like spots.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 09:45 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included benidipine hydrochloride (BENITOWA) for hypertension from unknown date. The past drug name was reported as no. 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. On 24Apr2021 at 07:00, the patient experienced itchy red spots anywhere across the body at one or two places at a time sometimes accompanied with hives like spots. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of itchy red spots anywhere across the body at one or two places at a time sometimes accompanied with hives like spots and included treatment with benadryl (antihistamine). The clinical outcome of the event itchy, itchy red spots and hives like spots was recovering at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Right upper arm swelling, mild erythema, induration and heat occurred within 24 hours of administration.
Systemic: Fainting/Unresponsive-Medium, Systemic: Flushed/Sweating-Medium.
pt states when she went to bed the day of her vax that her heart raced for about 30  minutes and she had severe chills for at least 12 hours.   She said she felt so sick she got up to call an ambulance but did not.  Pt stated she was very weak the next day after the vax.  Pt has not contacted her PCP but is wakes up every day weak and shaky.
documented MRI stroke; Appears to be thromboembolic; This is a spontaneous report from a contactable physician (reported for himself). A 48-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in right arm on 04Jan2021 07:00 as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. On 27Jan2021 14:00, it was reported that patient had documented MRI stroke, and appeared to be thromboembolic. Patient have no risk factors for CVA, and stroke occurred. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): stroke on 27Jan2021. Events resulted in doctor or other healthcare professional office/clinic visit, emergency visit and disability or permanent damage. Therapeutic measures were taken in response to the events which included patient had started on aspirin. The patient was not tested for covid post vaccination. The outcome of the events stroke and thromboembolic was recovering.   Information about lot/batch number is requested.; Sender's Comments: The causal association cannot be excluded between the reported events of "MRI stroke and appeared to be thromboembolic" and  BNT162B2 use. 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 AE. 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.
Patient was given their first Moderna vaccination on July  29th and the second dose of the vaccination was given a week short of the indicated time interval on 08/19/2021.
Right arm swelling, redness, warmth, light reaction in color, 4 in in diameter, good mobility.
Expired vaccine was given.  Expiration date is 10/10/2023.  Patient will receive a new dose in 1 month.
Patient came to immunization clinic 4/07/08. Stated that she was not pregnant. Patient made aware that MMR and varicella should not be given if pregnant and that she should avoid getting pregnant for at least one month after vaccination. Patient called clinic 4/2808 to report she had a positive pregnancy test 4/28/08.
Starting around 11:30am  the day after my vaccine I started to get chilled. As the afternoon progressed the chills became stronger and I felt nauseous and had body aches. I left work 1/2 hour early. I woke up the next day with the same symptoms but the nausea and body aches were worse and now my kidneys were tender. I went to work but continued to feel worse. I left work early that day and went straight to bed. I woke up the next day feeling so much better.
Father called clinic at 1:00PM, 12/21/10 with c/o fever onset 4PM 12/20/10 103.9 & now 104.0. (+) lethargy (-) vomiting or seizures. Inability to sleep. Gave acetaminophen recommended dose q 4-6 hr. Instructed to go to ER/U/C. Dr notified.
headache, muscle and joint aches, sore arm at injection site Experienced symptoms for approx. 24  hours
Slight fever, chills, tiredness, headache, slightly clogged nose, a few irregular heartbeats. Slept all day. Doubt cause is anything else. Hadn't been out without a mask and then only briefly. 5:25 pm on the 13th, still feel bad but chills gone.
Information has been received from a physician referring to a patient of unknown age. On 13-OCT-2015 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot # J013555 (expiration date 02-MAY-2015). No adverse events were reported. The outcome was unknown. Additional information has been requested.
2mo p/vax pt mom reported that pt devel a lump @ the inj site;pt was seen by MD who noted a firm, rubbery, non-tender, round lump which was 1 to 1.5cm in diameter;
I received the second dose of the Pfizer  Covid-19 vaccine on May 13. The injection site has been sore ever since. I have never had an adverse reaction to a vaccine before.
Information has been received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 29-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Rash 1st noticed behind ears, now on stomach, arms fine red rash behind ear papular rash scattered on thorax + extremities - 2 hours vaccine on 4/29/09.  1) keep skin clean + dry 2) BENADRYL go for pruritis, ok for hydrocortisone behind ear only.
I had a severe allergic reaction. A minute after the vaccination, my eyelids were swollen and puffy and itchy. I drank some water and couldn't swallow. My throat closed up. My arm was sore, swollen glands, swollen neck, swelling under my breast and underarms. I had blinding headaches and body aches.
A 0.5ml dose of FLUZONE QUAD was administered in error instead of the 0.25ml dose. MD was notified, he advised cool compress and APAP in case of swelling, which was not needed, no symptoms of event detected by staff or through follow-up with patient's father the next day.
For the initial 24 hours after receiving the first dose of Pfizer COVID-19 vaccine, patient had arm soreness that resolved. About a week later, she began to experience severe significant right arm pain. It is limiting her range of motion significantly. At this point, it is unclear whether or not this is related to the vaccine. She continues to have significant arm pain.
itchiness, extreme thirst, pain in leg reminscent of blood clots I  have had in the past
mom states pt ran a little fever afterwards, reported 25FEB94 well baby check @ MD's office; ran fever, unmeasured that noc; discovered not breathing 26FEB94 AM @ 6AM cold to touch, blue, fingers stiff, eyes fixed & dialated;
Headache particularly on left side with tinnitus, severe myalgias and bone pain. Unable to move much for 48 hours despite every 6 hours tylenol or advil
on 1/13/2021 at 3:40am Cliff called for assistance. He lost his balance and had fallen. Cliff refused vitals, refused emergency department, denied hitting his head.  As the day progressed patient developed a headache, diarrhea, and vomiting. He again declined the offer for the emergency room. At supper time wife and staff found Cliff unresponsive, 911 was called and he was taken to the emergency department. The ER did a CT scan and found an acute subdural hematoma. Patient was placed on comfort cares and expired at 3pm on 01/14/2021.  Cliff did not have a history of falls.
headache; sweats; fever; chills; PAIN AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills), INJECTION SITE PAIN (PAIN AT INJECTION SITE) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. .    No medical history was provided by the reporter.     On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and INJECTION SITE PAIN (PAIN AT INJECTION SITE). On 29-Jan-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 28-Jan-2021, PYREXIA (fever), CHILLS (chills) and INJECTION SITE PAIN (PAIN AT INJECTION SITE) had resolved. On 29-Jan-2021, HYPERHIDROSIS (sweats) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99f Inconclusive.
pt became pale & lightheaded, not feeling well, face, neck & arms wiped w/damp cloth;took pt to room lay down;3:55 112/80, P64, 4:10 110/72;
INITIAL SITE PAIN FOLLOWED BY LOCALIZED ITCHING AND HIVES (30 MINUTES AFTER VACCINE). HIVES AND ITCHING SPREAD TO BILATERAL ARMS , TRUNK,  NECK, AND FACE (60 MINUTES AFTER VACCINE) AND CONTINUED TO GET WORSE (90+ MINUTES AFTER VACCINE). ORAL LORATADINE TAKEN AT INITIAL ONSET OF SYMPTOMS. IV SOLUMEDEROL, BENADRYL, AND PEPCID GIVEN APROX 2 HOURS AFTER ONSET OF SYMPTOMS. SYMPTOMS HAD MOSTLY RESOLVED APROX 60 MINUTES AFTER IV MEDICATIONS. HIVES AND ITCHING RETURNED WITH FEVER/CHILLS APROX 0300, 50MG ORAL BENADRYL TAKEN AND RESOLVED SYMPTOMS.
No additional AE reported; the patient moved and that caused the medication to squirt in the nurse's eye; the patient moved and that caused the medication to squirt in the nurse's eye; the patient moved and that caused the medication to squirt in the nurse's eye; This spontaneous report has been received from the patient's colleague (nurse) referring to a female patient of unknown age who was also a nurse. The nurse's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 16-FEB-2023, the nurse was administering measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection (lot number W028558 has been verified to be valid, expiration date was reported and established as 06-MAR-2024 upon internal validation; dose and route of administration was not reported) to her patient, and while the nurse was injecting the medication, her patient moved and that caused the medication to squirt in the nurse's eye (exposure via eye contact, occupational exposure to product, accidental exposure to product). No further information was provided. No additional adverse event (AE) or product quality complaint (PQC) was reported.  This is one of two reports from the same reporter (link # US-009507513-2302USA005740).; Sender's Comments:  US-009507513-2302USA005740:Case Number 02337536
Dizziness  Vital Signs: BP 112/80 HR 78 Resp 12 O2Sat 96%  Skin Signs: Diaphoretic  Circulation: Cap Refill <2sec  Respiratory: Breath sound clear bilaterally, Wheezing  Initial Treatment: Hydration and support  7:15 PM Vital Signs: BP 115/70 HR 74 Resp 12 O2Sat 96%  Skin Signs: Cool and dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally, Wheezing  7:30 PM Vital Signs: BP 118/75 HR 70 Resp 12 O2Sat 93%  Skin SIgns: Warm and dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally, wheezing  Follow up Treatment: Supportive
I developed a high fever the next morning with chills, aches, fatigue, headache & injection site pain & swelling.   I called caregiver health & communicated with my Dr.  I was instructed to get a covid test, take Tylenol, ibuprofen, Benadryl if I developed a rash at the injection site, ice & rest along with push po fluids & self isolate. I had fever 104-103 at it's worst, tachycardic at 120 & pulse ox 85% in the midst of the fever.  I tried to just use Tylenol, but it would not break the fever.  A tepid bath & alternating ibuprofen helped.  It is day 3, my fevers are resolving, but no a rash is beginning.  I am coming through the experience, but I am curious if these shots need to be given further apart...   My covid test just came back negative, which I assumed it would.  I believe this was a heightened immune response.  I have many colleagues with  similar experiences.  I have had soreness & mild symptoms from previous vaccinations, but nothing this severe.
Within two hours the arm became itchy, swollen and red hot. It continued to get worse over three days. In additional I had exhaustion. The symptoms continued for the next four days and began to subside on the sixth day. At this writing I am at the seventh day and till have residual symptoms which are gradually diminishing.  The degree of itchiness could be described as like bad shingles. The degree of redness could be described as a bad sunburn. The degree of swelling was like a hard muscle cramp in my deltoid, triceps, and biceps widespread across most of the upper arm and shoulder.
This spontaneous report as received a doctor or pharmacy concerning her daughter who on an unspecified dates, was vaccinated in the buttocks with all 3 doses of GARDASIL (date and lot numbers not reported). No adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent (MRK).The patient's concurrent conditions and medical history were not reported. On 12-JUL-2017, the patient was vaccinated with a dose of ZOSTAVAX intramuscular route instead of subcutaneously, for prophylaxis (dose, frequency, lot/batch # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
received Flulaval incorrectly stored at -0.1C.; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Age at vaccination was not applicable for this report. The reporter stated that about 44 patients were administered with Flulaval which was incorrectly stored at minus 0.1c. No symptoms reported. The reporter did not have any patient/vaccination details at the time of report. The reporter consented to follow up.
On the night of 2/26/2023, I had a scratchy throat. On 2/27/2023, I continued to have a scratchy throat. I took a home antigen test and got a negative result. On 2/28/2023, I began to have a severe sore throat. I took yet another home antigen test and got another negative result. I then developed a severe migraine. On 3/1/2023, I woke up feeling very sick. I had the sore throat and migraine. I took another home antigen test and got a positive result. I was sick for over two weeks. I also had severe fatigue and spent a lot of time sleeping. I began to feel better on 3/4/2023. I was still extremely tired at this point, though, and I developed a slightly productive cough. I went to the doctor on 3/13/2023. I was given an albuterol inhaler, and I took Mucinex. Within another week or so, I began to feel better. It took a good three weeks before I was back to my old self. The cough persisted until about 3/20/2023.
23JUN95 blank stare @ 11AM; fever 103.5 @ hop p/having APAP; jerking sz like activity was observed @ ER in 2 hr no further sz fever brought down by suppository;
My right arm at my shoulder and my elbow, and the top part of my wrist has had pain that has gotten progressively worse. I am in physical therapy right now.  getting weaker and weaker.  I was told I have tennis elbow.
Patient reported event on 10/30/2014. Described progressing soreness and heat at injection site that wouldn't resolve with ice. Eventually, patient saw prescribing physician and was hospitalized for diagnosis of cellulitis and treated with antibiotics.
medical assistant misunderstood and gave Adacel to the child by mistake instead of his mother, no AE; medical assistant mistakenly gave adacel to 4 month old infant, no AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a four month old male patient to whom the medical assistant by mistake administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6401AA, expiry date-05-Nov-2021, prefilled syringes) via intramuscular route in the left fasciitis lateralis for prophylactic vaccination on 02-Mar-2020 instead of his mother (Wrong patient received product and Product administered to patient of inappropriate age).   Medical history, past medical treatment, vaccination and family history were not provided.  On 02-Mar-2020, the patient received a dose of concomitant vaccinations which included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong patient received product and inappropriate age at vaccine administration.  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 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.