chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of skin discoloration in an adult female subject who was vaccinated with Flu vaccine, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On 21 October 2008 the subject received unspecified dose of Flu vaccine (unknown).  The reporter, who was also the subject, could not confirm which GlaxoSmithKline flu vaccine she was given, but she provided a partial lot number reported as "UL2757AA".  At an unspecified time after vaccination with Flu vaccine, the subject experienced skin discoloration, leg rash and swelling.  At the time of reporting the outcome of the events was unspecified.
Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient was a minor (15 years old and 5 months) at the time of vaccination with 1st dose on 2/28/2021 and was a minor (15 years and 6 months) at the time of vaccination of 2nd dose on 3/21/2021. Healthcare facility notified by public health dept.
I received COVID vaccine (Spikevax) late afternoon on 10/13/2023. In addition to my typical reaction to past COVID vaccines (severe chills, presumed fever, severe HA, arthralgia, N/V), I developed severe facial and periorbital edema as well as severe swelling of hands and feet. I have both Cutaneous Mastocytosis and Indolent Systematic Mastocytosis (CM, ISM, both diagnosed in 2023); the rash associated with CM was triggered. Additionally, I had moderate lightheadedness and vertigo as well as hypotension as per home blood pressure monitor. I have two Epipens with me at all times as ISM is associated with a high incidence of anaphylaxis due to mast cell activation but did not use them. Note: ISM is a chronic myeloproliferative neoplasm associated with exceedingly high mast cell burden. Triggers cause degranulation of these mast cells. Typically, ISM is associated with a non-immunologic reaction as opposed to an immunologic IgE-mediated reaction. I had no angioedema, hives, or difficulty breathing which are more commonly associated with the latter. I did not seek treatment at a hospital. Instead, I received IV fluids (3 L D5W or LR) at home for dehydration, treated the N/V with prochlorperazine and ondansetron (not at same time, both prescribed prior to vaccine administration based on history), and maintained my regimen of cetirizine 10 mg TID, cimetidine 200 mg BID, and Singulair 10 mg QD. My symptoms gradually improved over 3 days with the exception of vertigo, dizziness, severe HA, difficulty maintaining balance, and nausea. I sought treatment in the ED on 10/18/2023 for worsening symptoms. I received 1 L LR and an unknown dose of IV ondansetron. I was worked up for a PE and MI. CT with contrast was negative for both); repeat troponin levels and 12-lead ECG were normal. I was subsequently released. (Yes, in hindsight I know I should have self administered epinephrine and sought emergency medical care on 10/14 and/or 10/15/2023).
Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No corrective treatment was reported.
Period came one week early and then a week after that. Spotting. Missed next period.  Not pregnant. Confirmed by doctors
Aphthous ulcer of mouth, swelling of hands and eyelids, fatigue, nausea Treatment: Triamcinolone acetonide 0.1% dental paste, ondansetron HCL 4mg, prednisone 20 mg
consumer reports that daughter was administered DTP & 1 wk p/vax was treated w/ATB; 2 wks p/stopped breathing; placed on ventilator; p/2nd vax (date ?), completely paralyzed for months; dx post vax neuritis (GBS);
received the covid-19 vaccine on March 18 following a temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the covid-19 vaccine on March 18 following a temperature excursion) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the covid-19 vaccine on March 18 following a temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the covid-19 vaccine on March 18 following a temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were reported. No treatment related information has been reported.
Vaccine administered 6 hours after reconstitution...Contacted PFizer, CDC, ACIP and local epidemiologist. Physician advice was followed to consider dose give as valid and offer re-vaccination only if patient wanted.  Patient was contacted and expanded the issue offered advisement from physician and offered re-vaccination if wanted.  no adverse reaction s/p vaccination.
The first day just my arm hurt, but 24 hours later both arms both legs my back and neck hurt so much so that I just had to lay down for the rest of the night
On Sun. 11/11/07 in the morning started having pains in tops of feet, then progressed to soles of feet, then up calves to backs of thighs.  Continues to have pain in legs, esp. knees and legs feel very fatigued which is making it difficult for him to work.  He has had back pain before this so Dr. ordered MRI of back.  Saw Neurosurgeon who told him he could not see any reason for his leg problems or his back pain. Had to quit his job due to pain in legs.
"FEELS LIKE I CAN'T TAKE A FULL BREATH", CHEST TIGHTNESS, TONGUE"FEELS FUNNY", ARM NUMB FROM INJECTION TO ELBOW, "FEELS FUNNY"
Information has been received from the authors in a literature article concerning an unknown gender 36 year old healthcare worker with MMR vaccine (manufacturer unknown) route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health (DPH) guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 measles, mumps, and rubella (MMR) vaccines doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at HCA or at the facilities where patients presented. All positive samples from community laboratories were confirmed by health care agency (HCA), which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at HCA using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (Hl), and fusion (Fl). The DPH Viral and Rickettsial Disease laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR vaccine (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
This initial spontaneous report was received from a physician referring to a 9 week-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 09-SEP-2015 at 08:25 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Patient was transported to hospital. She was diaphoretic, nauseas and almost passed out. She just had a pacemaker put in 3 months ago. EKG was done by paramedics and they immediately recommended transport to the hospital.
PATIENT DOES NOT HAVE AN ADVERSE EVENT BOOSTER DOSE WAS ADMINISTERED BEFORE THE RECOMMENDES TIME. SECOND DOSE WAS ADMINISTERED IN 11/11/2021 AND BOOSTER DOSE WAS ADMINISTERTED ON 02/23/2022
Mom reported event on 10.13.10. She states after pt rec. vaccines he awoke on 12.25.09 with a rash on his abdomen & legs which then spread all over. Pt felt uncomfortable. Mom gave BENADRYL which helped. Pt then developed whelps on 01.11.10.
Severe increase in Tinnitus frequency, duration and loudness. I have had mild and rare events of Tinnitus for many years but never to the point of seeing a doctor. Went to see Doctor on 4-8-2021 and tests are ongoing. On 4-1-2021 the Tinnitus started much louder  thanevery before and lasted for 4 days until relenting some what. Still have mild to severe Tinnitus almost most of the time.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: PT FELL FROM CHAIR- POSITIONED PT TO LIE FLAT DOWN UNTIL PT WAS ABLE TO GET UP.
Red rash on arm and neck. Itch and burn. Patient received treatment w/ Valacyclovir.
PATIENT RECEIVED SINGLE DOSE OF JANSSEN COVID19 VACCINE ON 5/04/2021. ADMITTED TO MEDICAL CENTER ON 08/15/2021 WITH WORSENING SHORTNESS OF BREATH. TESTED POSITIVE FOR COVID19 ON 08/10/2021 AFTER STARTING CHEMOTHERAPY FOR SMALL CELL LUNG CANCER THE WEEK PRIOR. REQUIRED HI FLOW O2 IN ED, STARTED ON DECADRON, REMDESIVIR, CEFTRIAXONE, AND LASIX. PATIENT HAD PROGRESSIVE RESPIRATORY DECLINE. FAMILY ELECTED TO PURSUE COMFORT MEASURES. PATIENT EXPIRED ON 08/18/2021.
Pfizer monovalent covid vaccine was given instead of bivalent Pfizer covid vaccine.
significant lymph node swelling; body aches; unable to walk/stand; unable to walk/stand; chills; headache; sore throat; This is a spontaneous report from a non-contactable nurse.  A 28-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 21Jan2021 at single dose for COVID-19 immunisation.  Medical history included asthma, fibromyalgia, anxiety, depression and known allergies: penicillin.  Concomitant medication included escitalopram oxalate (LEXAPRO), loratadine (CLARITIN [LORATADINE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA).  The patient previously took first dose of BNT162B2 on 02Jan2021 on the left arm. The patient experienced significant lymph node swelling, body aches, unable to walk/stand, chills, headache, sore throat on 21Jan2021.The patient received no treatment.  The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sore arm for one day. Wrist pain that has persisted for over a week following vaccination.
pain is in top of neck; pain is in top of her forearm over the shoulder blade (more in back than front) to top of neck and chest; unable to ambulate; Yesterday her arm bad she can hardly lift her arm; did not sleep very well last night; pain is over the shoulder blade (more in back than front); arm started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain is in top of neck), PAIN (pain is in top of her forearm over the shoulder blade (more in back than front) to top of neck and chest), GAIT INABILITY (unable to ambulate), INJECTED LIMB MOBILITY DECREASED (Yesterday her arm bad she can hardly lift her arm) and INSOMNIA (did not sleep very well last night) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm started to hurt). On 21-Apr-2021, the patient experienced NECK PAIN (pain is in top of neck), PAIN (pain is in top of her forearm over the shoulder blade (more in back than front) to top of neck and chest), GAIT INABILITY (unable to ambulate), INJECTED LIMB MOBILITY DECREASED (Yesterday her arm bad she can hardly lift her arm), INSOMNIA (did not sleep very well last night) and ARTHRALGIA (pain is over the shoulder blade (more in back than front)). On 21-Apr-2021, INSOMNIA (did not sleep very well last night) had resolved. At the time of the report, NECK PAIN (pain is in top of neck), PAIN (pain is in top of her forearm over the shoulder blade (more in back than front) to top of neck and chest), GAIT INABILITY (unable to ambulate), INJECTED LIMB MOBILITY DECREASED (Yesterday her arm bad she can hardly lift her arm), PAIN IN EXTREMITY (arm started to hurt) and ARTHRALGIA (pain is over the shoulder blade (more in back than front)) outcome was unknown.            No concomitant medication were reported.  No treatment information was provided.
Symptoms started on 1/16/21 with redness, swelling, pain, warm to the touch, spreading down arm.
product excursion occured during shipment with no adverse event; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer non health care professional via Medical Information number: 00785004.  This case involves an unknown age and unknown gender patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product temperature excursion issue).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ759AC and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to product temperature excursion issue (latency: same day).  It was reported that Receptionist states she already spoke to customer service and is having products replaced. Receptionist states she was told to call medical information because they did administer FLUZONE HIGH DOSE to 11 patients before they were notified that their products would not be suitable for use. Receptions asks what they should do in this situation. Receptionist states she does not have information to complete AE/safety report for the 11 patients at this time. Additional Description of event Adverse events :Receptionist states they received a notification that their shipment of FLUZONE HIGH DOSE took more than 2 days in shipping and the product is not suitable for use. Receptionist states she already spoke to customer service and is having products replaced. Receptionist states she was told to call medical information because they did administer FLUZONE HIGH DOSE to 11 patients before they were notified that their products would not be suitable for use. Receptionist asks what they should do in this situation. Receptionist states she does not have information to complete AE/safety report for the 11 patients at this time. Receptionist states they will begin gathering information for AE/safety report and agrees that they can be contacted by Sanofi.  At the time of reporting, 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 the 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.
vaccine administered 10/18/23, pt reports vaccine administered very far forward, nearly to arm pit.  Pt reports increasing joint/nerve discomfort on 10/19/23 and for several weeks after.  Reported to pharmacy on 11/12/23.  Pt states pain is resolving at this point
About 2-5 minutes after receiving shot I felt a twitch/bubbling feeling in the left side of my face. I immediately started getting anxiety and my hands began to sweat. I also started getting a mild pain in my lower spine. Which is still persisting today (2 days later). Yesterday I was pretty tire and had aches all day that came and went. It was very hard to work from home but I managed to work 6 hours with breaks. Also yesterday and this morning when I got out of the shower I noticed 2-3 itchy red bumps on my stomach area. I?m not sure if I had a mild allergic reaction to the vaccine. Either way, I will most likely contact my doctor before I get my second dose. I hear the second dose is more intense which makes me hesitant as the first dose debilitated me quite a bit.  I am usually very healthy and have never had any allergic reactions which makes this puzzling. The only thing that comes to mind that may have caused this is mushroom immune supplement. Any info will be much appreciated, thanks.
I did have a shingle vaccine and I developed pulmonary edema and hospitalized from 12/18 to 12/ 24/2019 The doctors could not figure out , no fiver, just short of breathing and heavy coughing .( check the heart, cat scan etc. ) They removed over 3 litters of water from my right lungs. I mentioned to them having the shingle vaccine and was it was removed as a cause. I did get better and in May I did have my second shingle vaccine AND AGAIN I DEVELOPED THE PULMONARY EDEMA. STILL DOCTORS DO NOT BELIEVE IS FROM VACCINE. Cancer has been tested and no indication. I will have a Cat Scan on October 5th 2020 but I believe is from the SHINGLE VACCINE. I was and I am treated at Hospital and the physician is Dr., pulmonary and internal medicine.( a wonderful human being ) Please, you have to investigate and correct the situation and let people know what is going on. This is a life saving matter.
Information has been received from a physician concerning a female (age not reported) with no pertinent medical history who on an unspecified date was vaccinated with a second dose of Gardasil (lot # unknown).  Concomitant therapy included (dip toxoid) (MENACTRA).  On an unspecified date, "almost immediately after receiving the vaccine", the patient had "fainted and felt dizzy".  No further information was provided.  Medical attention was not sought.  At the time of reporting it was unknown if the patient had recovered.  Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Within a few minutes, pt began to sweat/feel light headed/dizzy/ringing in the ears.  Pt stated he felt like he was going to pass out.  Pt reported no symptoms related to anaphylaxis.  Pt did not lose consciousness and symptoms started improving within 10 minutes.  Pt then noticed blurry vision which resolved.  Pt's BP was checked: 120/90, pulse WNL.  Pt. was feeling fine but per PCP  guidance, went to ER for a follow up when I followed up via phone.  Reported no further issues after leaving pharmacy
immediately after receiving her vaccination she developed lightheadedness. She has an aversion to needles.
At 5am on the morning of 10/30, three days after receiving both vaccines, he suffered a severe stroke in his sleep.  The stroke was an occipital frontal lobe, resulting in paralyzation on his right side and global aphasia, and a 55% reduction in his mental capacity.   He was hospitalized and in rehab for approximately six months.  He now requires full-time care in home with no change in his condition since the stroke.
pt recv vax 24OCT96 & 28OCT theophylline level was 17.3;this is 1 of 2 pt from this sit to devel elevated theophylline levels p/vax;pt theophylline dose was inc on 22OCT96;
redness, itching edema @ inject site, approx 2 1/2 x 3 1/2 w/approx 1/2" diameter indurated area @ inject site; pt used heating pad to site, starting on day of inject; also used Cortisone cream to site to relieve itching;
Diarrhea, ABDOMINAL PAIN Narrative; MISSED WORK DUE TO SYMPTOMS
Pt is 15 years old. Pt received the Moderna vaccine in error on 29 OCT 21. Guardian brought pt to clinic for regular visit with provider. Pt due the second COVID vaccine. RN talked to physician who recommended that guardian be given the choice of completing series with Moderna or waiting until 3 DEC 21 for Pfizer. Guardian chose to complete the series with Moderna. RN administered Moderna.