chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt's father requested Moderna booster for patient who had completed a primary Pfizer series. Vaccination proceeded with consent. As per phone conversation with father on 3/5/2022, Patient feels fine and denied any reactions from the booster.
He received bothe the Flu and Covid Bivalent booster in same arm (right) deltoid, then seemed ok. I then gave a flu shot to his sibling and in the interim after he got up to leave he said something to his mother that he was feeling weird and then as I looked over my shoulder he went to his knees and passed out what looked like a vasovagal response to perhaps 2 vaccinations. After some time I helped him to a chair, offered him a bottle of water and monitored him. He said he was feeling better and no complaints of swollen tongue, or throat. An ambulance was offered but he and his mother refused and after sitting for about 15 minutes his father arrived and they left.
Fever, chills, body aches, muscle cramps in legs, nausea, fatigue
3/23/2022 Patient received her 3rd Pfizer vaccine at 11:15 in clinic.  Was observed for 15mins and returned to work.  She developed diaphoresis about 40 minutes after the vaccine. She reported to office with a red face and body sweating.  Patient continued to have symptoms of hyperhidrosis.  Vitals, monitoring and treatment with loratadine 10 mg po one-time.
no additional adverse event; Medical assistant reporting a vaccine was administered after a temperature excursion. No additional AE. No PQC.          ?    Names of vaccines involved (including lot/exp) VAXNEUVANCE U036156 5/25/2023        ?    Temperature 9.2C for 3 hours; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 28-SEP-2022, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) prefilled syringe, 0.5 milliliter, lot #U036156, expiration date: 25-MAY-2023, administered as prophylaxis (strength, and route of administration were not provided).  It was reported that the vaccine was administered after a temperature excursion at a temperature of 9.2 Celsius degrees (C) for 3 hours (product storage error). A previous temperature excursion was reported at a temperature of 15C for 1 hour. No additional adverse events were reported.
Information has been received from a physician's assistant concerning a 77 year old female patient who on 28-JUN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# and expiration not reported). Concomitant therapy included AMBIEN and SYNTHROID. It was reported that three days later, on 01-JUL-2011 (also reported as 31-JUN-2011) the patient developed shoulder pain, generalized weakness and arthralgia, but the patient previously had been otherwise healthy. Physician assistant reported that she tested the patient for rheumatoid arthritis or another autoimmune issue, and she stated that her ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were positive. Physician assistant stated that the laboratory values were not indicative of rheumatoid arthritis, and she suspect a possible reaction to ZOSTAVAX (Merck). Patient sought unspecified medical attention. No treatment was given for this adverse event. At the time of reporting the patient had not recovered. The patient's shoulder pain, generalized weakness arthralgia and possible reaction to ZOSTAVAX (Merck) were considered by the physician's assistant to be disabling. Additional information has been requested.
itchy; numb lips; tingling face; joint pain; chills; extreme fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy), HYPOAESTHESIA ORAL (numb lips), PARAESTHESIA (tingling face), ARTHRALGIA (joint pain) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (itchy), HYPOAESTHESIA ORAL (numb lips), PARAESTHESIA (tingling face), ARTHRALGIA (joint pain), CHILLS (chills) and FATIGUE (extreme fatigue). At the time of the report, PRURITUS (itchy), HYPOAESTHESIA ORAL (numb lips), PARAESTHESIA (tingling face), ARTHRALGIA (joint pain), CHILLS (chills) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Red rash noted to lower abdomen and around umbilicus. Has Dr. apt today (3/22). Had low grade temp x 3 days last week according to mother.
NOSE BLEED; MUSCLE CRAMPING; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 51 year old. 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: 041A21A, expiry: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced muscle cramping. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed on 13-APR-2021, and fever on 10-APR-2021, and had not recovered from muscle aches, and muscle cramping. This report was non-serious. This case, from the same reporter is linked to 20210427147.
Lump in back of throat Sometimes hard to swallow Tongue numb sometimes - comes and goes This has been on going since Saturday, March 20. I?m hoping it will eventually go away. I have my second vaccination appointment on April 10.
about 9 hours after receiving first dose of COVID19 vaccine, I experienced severe abdominal cramps for ~2 hours. The pain was extremely intense and felt very similar to contractions during childbirth, only without relief between them - an ongoing very intense cramp / pain. Movement was severely limited due to pain. A bath didn't offer any relief. Pain subsided after taking extra strength Tylenol. No bleeding was observed. The following day there was till a weak pain.  I didn't experience a similar event at the second dose.
Patient given an adult dose of Pfizer when patient is a pediatric patient. Infectious disease doctors on site consulted, parents of patient notified of error and given information and recommendations from infectious disease specialists.
Began to have bilious emesis about 2 days after immunization was given and then also began having diarrhea.  Had one episode of bilious emesis then resolved for 2 days then again -- Upper GI obtained (normal), bilious emesis again, went to ED then transported to Hospital (pediatric surgery).  Monitored there had negative enema and negative stool workup, no further emesis and diarrhea resolved.  3 days later infant eating well and gaining weight. 11/21/08-records received for DOS 10/29-10/31-08-DC DX: Gastroenteritis. Now presented with 3 day history of bilious emesis and diarrhea.
Approx 4 hours after administration patient c/o itching of eyes, nose, throat, then arms, legs began to itch, no hives.  Did develop a cough and still has it.  No SOB.
AFTER THE VACCINE HE WAS COMPLAINING ABOUT BEING UNCOMFORTABLE. ON SITE EMS RESPONDED, VITALS LISTED BELOW. EMS HAS IT LISTED AS A POSSIBLE ALLERGIC REACTION. HE RECOVERED AND LEFT TO HOME.
Primary complaint is extreme dizziness; I've almost fallen twice and I'm very unsteady on my feet. Never experienced any of this prior to the vaccine. The secondary complaint is swelling, redness and pain at the injection site.
Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Within 24 hours, I developed severe headache, dizziness, nausea, fever, chills, sweats, sore throat, and tender axillary lymphadenopathy on the arm that vaccine was administered, diffuse myalgias.  Vaccine related event was rapid onset (within 24hrs) and rapid offset (80% better 12-16 hours later).  Treated with acetaminophen only.
Patient given the wrong dose (20mg instead of 10mcg) of the Pfizer vaccine.
mom states pt was sleeping, awakened, eyes rolled back in head w/sz like activity approx 8PM;835PM ER report states pt awake, lethargic, skin & mucous membrane dusky;weak cry;no reps distress;t101.9 R;tx 02 mask;given APAP & Ibuprofen;
Erythema, edema, pain, tactile warmth began on 9/28/20, the same day he received vaccines.  Parent treated with ice and Tylenol at home.  Parent reported reactions to PCP office on 9/30/20 and was advised to have him seen.  Parent took him to an Urgent Care where they prescribed Benadryl and triamcinolone acetonide topical cream and advised to keep clean & dry and take IBU PRN.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: At the time I was administering another COVID vaccination, and heard the patient fall on the floor upon which I noticed he was lying flat on the ground not responsive. I had one of the customers call 911 and assessed his vitals, he was breathing and conscious and speaking. He told me he still had trouble breathing and he felt very cold. By the time the paramedics arrived on the seen and helped the patient sit up on the chair he was feeling better. He was taken to emergency services soon after
Experienced sharp pain around area of heart about 3 hours after receiving vaccine. This lasted for about 2 days. I took Tylenol to try and help relieve the pain.
Watery eyes, runny nose, cough, mild fever, irritability, decreased appetite, tiredness, mild rash
Vaccine was administered on 10/23/07 and within 24 hrs patient experienced an urticaria type rash over entire body and became very irritable. No fever, and no other symptoms other than the above. Pt. was prescribed Benadryl for 5 days.
I was experiencing mild tinnitus off and on prior to getting my first shot. Like three or four times a week in the afternoons and evenings. The day after I got my first shot (Moderna), the tinnitus was immediately noticeable while waking up that day and has been constant ever since.  It is currently barely tolerable but I'm having second thoughts about getting the second dose.  As best I can tell, there is no treatment available for tinnitus.
Information has been received from a physician who mentioned that she read an article in the magazine which referenced a female patient who on an unspecified date was vaccinated with unspecified dose of GARDASIL (lot# not reported) and the patient experienced "joint issues" several months after receiving GARDASIL. It was reported in the article that a chiropractor was treating the patient with manipulation. At the time of this report, the patient's outcome was unknown. Attempts are being made to verify the existence of an identifiable patient and reporter. Follow up information has been received from a medical assistant who stated that the physician did not remember the name of the article and stated that the article appeared in the March issue. Additional information is not expected.
Chest pain, sharp stabbing pains, difficulty breathing, shortness of breath, unable to move quickly, fluttering heart beat, pounding heart beat, headaches, fatigue, arm and back pain on the left side, loss of appetite that is more than normal.
Patient had immunization on 4/17 and 4/20 3 days later had rash which was papular all over but not erythematous. No fever, IgE lever done was not present.
Right leg pain and neuropathy started on or around June 1st and progressed to bilateral calf neuropathy and pain, bilateral foot neuropathy and pain,  bilateral hand neuropathy,  fatigue, and generalized sharp pains that would last a short period of time
Sore arm and next morning extreme bodyaches and low-grade temperature of 99.7, chills, nausea and extreme fatigue.  No treatment
This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer-sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), administered in arm, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had dizziness/dizzy, neuralgia/nerve pain in mouth/jaw, and pain in extremity/pain in arm used for injection (non-serious), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Partial facial numbness on the left middle of face starting 11-6-02 evening. ENT eval & MRI showed no signs of sinuse infection and MRI was normal.
Extreme heat under skin Rash in different areas of body Hives after itching Dermatographic urticaria
Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and drug reactions/allergies were not provided. On unknown dates, the patient were vaccinated with improperly stored doses of PROQUAD (rHA, lot # M018636, expiration date 11-OCT-2016; dose was unknown). The vaccines were stored at 7.5 Fahrenheit degree for 2 hours 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left deltoid with sore hot area about 50 cent size. Area is red with lump.
Rock solid lump over my collar bone possibly lymph nodes, it started 7-8 days after the shot and I still have it same side where I got the shot, 3 days after the shot I also got pain on my armpit . I?m worried about lump over my collarbone
Ringing in my ears and a sharp headache began about 4 hours after vaccine.  It is a high pitched, non-pulsatile ringing and hissing noise.  The headache comes and goes throughout the day and evening and is of the sharp, stabbing variety along temples and at base of skull. I have never had ringing in my ears before this time so I know it is directly related to the vaccine. I had no other adverse effects except a mild headache the day after the vaccine.
Three inch red spot around injection site, small hard spot in center of site, no fever, some tiredness and sleeping done by child, per patient's mother. Mom stated that the red spot is still present, not as big and is not hurting child. Mother did not wish to be seen in office at the time.
I woke up this morning after my vaccinations to what sounds like a car blasting a loud bass outside. As I walked around the house, the sound didn?t change in volume whatsoever, and I realized that it was localized in my right ear.  It?s a fairly loud, deep rumbling sound. I can hear over it, but it?s a constant thrumming that I have never had before until today.
States "had a mild reaction following the flu vaccine; within 15 minutes after receiving noted tickle in throat, pre asthma symptoms." Denied any SOB or chest pain. C/O dry throat and had end expiration dry cough. Took over the counter Benadryl and used Albuterol MDI. Symptoms gone 1-2 hours.
pt received the  Covid 19 vaccination at 1pm EST at the Clinic.  At approximately 1:05 the patient began to feel itchy  and irritation to skin. pt says she has had allergic reactions to flu shots in the past and reported itchiness to peanuts and strawberries. At 1:10 the pt was administered 50 mg of Benadryl. At 1:25 patient reported itchiness to back B.P. was 122/74 at 1:55pm and the patient had recovered from previous symptoms. At 2:00 p.m. the patients friend picked her up and transported her home in her vehicle.
Arm red & sore to touch at injection site. Pt jaw also sore at roof of mouth. Patient given Prednisone.
Patient complained of swollen arm, swollen lymph nodes, nausea and vomiting, shoulder pain, fever of more than 107 F and infection of lymph nodes. The swelling lasted 7 days while the lymph nodes infection lasted 3 days.
10AM 15FEB95 recvd vax & eyes rolled & pt went limp x 15sec then regained airway & crying; 2nd shot given no problem; 2PM same day mom concerned pt has not stopped crying, nothing consoles pt, claws @ parents, shaky like, chills, t101.5;v
Patient said her arm was sore and redness which had grown from a penny size to a quarter size. Wasn't feeling well either - tired. MD is informed and will call us back with any updates.
Temperature, headache, body aches, very sore right arm (wasn't moving well), sore neck, scratchy throat, extremely tired, diarrhea (w/2nd shot only), sweating, blurred vision (2nd shot only), tinnitus in right ear (got worse), nausea, cough, sneezing and balance issues got worse (more frequent).
patient fainted and regained consciousness in 3 seconds.  patient cold and sweaty, elevated pulse. called 911. vitals stable, no signs of allergic reaction. mother denied transport to facility.
Developed chronic hives/urticaria/dermatographia. Initially taking 4 Xyxal per day and 1 Benadryl at night, along with topical steroid creams, and tried 5-day prednisone. Currently, 6 weeks into the hives, I'm taking 1 xyxal per and using Sarna anti-itch lotion.
Medical assistant gave MMR the wrong route. it was given intramuscular instead of being administer sub Q
Acute on chronic systolic heart failure. Patient was diuresed with an improvement in symptoms. She remains rate controlled on BB therapy. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Dizziness starting - few hours after vaccination. Persisted for 2 wks. Evaluated by EMT.
This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in a 32 year old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 25 March 2007, 29 December 2006 and 27 November 2006 the subject received 3rd, 2nd and 1st dose of Engerix B (unknown deltoid) to complete the three dose series.  On an unspecified date following completion of the Engerix B series, the subject had a negative titer.  The reporter suspected a possible quality issue with the vaccine.  At the time of reporting the outcome of the events was unspecified.
sore arm; Cough; Headache; Upset stomach; This is a spontaneous report from a Non-contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history, concomitant medications and past drug history were not reported. Reporter stated that she had a couple questions nothing bad. Her question was, if she had the first vaccine and there was no symptom, just a sore arm, but then she starts to develop couple weeks later a cough, headache, upset stomach, unsure if its related to the vaccine or could be covid 19 exposure. Patient asking is it possible to still get the second vaccine, if there were body aches but no fever and did not test positive for covid. At the time of this report event outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had syncopal episode, shortness of breath, headache, throat felt "fuzzy" Injection site swollen, red, achy.
Patient (self) woke up the day after the vaccination with a light-sensitive migraine that lasted from 8am until approximately 10pm the same day. After the migraine resolved, patient experienced extreme anxiety (likely panic attack) accompanying by uncontrollable shaking of both legs and loud crying producing tears. Prescription medications were taken on schedule, but the vaccination event may have triggered breakthrough anxiety and/or feeling of helplessness ~36 hours after vaccine received.
Very sore shoulder joint.  Swollen lump on arm at injection site.  Warm. Itchy.  Sore ness at site.  Slightly red.   Hard to mobilize shoulder.
Arm very sore & painful all the way down including hand; couldn't sleep on rt side x 2 days;
Administration error- patient was 16 years old when she received her second dose. The first dose was given on 05/06/2021 and was reported to VAERS. The second dose was given in accordance with CDC recommendations.  Adverse reaction- (dose administered in day 0) Sore arm and headache on day 1. On day 2 and afterward, patient felt fine and engaged to her usual activities.
expired PENTACEL given to an infant with no AE; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 3 months old female patient who received expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and IMMUNOGLOBULIN ANTIHEPATITIS B (HEPATITIS B)  On 10-Nov-2020, the patient received 0.5 mL once daily dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE via intramuscular route in right vastus lateralis (lot number: UJ057AAA and expiry date: 07-Nov-2020) for prophylactic vaccination.  This was an actual medication error due to expired vaccine used (PT: expired product administered) (latency was same day).  No laboratory data reported.  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 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.
pt recv vax; woke up on 11may w/ swelling, pain in upper lt arm; apap given;