chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient awoke morning after vaccination and noted a 7mm spot on her right arm without pain or pruritus. She left the country on 5/5/18 as anticipated and contacted the clinic on 5/7/18 with complaints of diffuse whole body rash that she noted when awakening in her hotel on 5/6. First noted rash on chest but quickly spread to entire upper body including arms, back, some on buttocks. By follow up email somewhat improved. By photo maculopapular. She reports a moderate, dull headache and bilateral eye pain for about 48hrs when going to the airport on 5/5, but no rash then. She noted chills and subjective fevers, but did not take her temperature that resolved by time she reached the hotel in another country. Generalized weakness and fatigue.
RECEIVED DTAP. MCV4, VARICELLA AND HPV ON 6/1/09 WITH NEGATIVE PREGNANCY TEST.  HAS HAD NO ADVERSE EFFECTS.  PT NOW HAS A POSITIVE PREGNANCY TEST.
Patient received the first of the two Shingrix immunizations on the afternoon of 8/29/2021. He received the shot in the left deltoid muscle. Later that evening, he states he began to experience pain in his right hip/groin region.  The pain made it difficult to sleep throughout the night and early morning of 8/30/2021. Beginning Tuesday, 8/31/2021, the right groin/hip region broke out in a rash resembling that of zoster. The patient contacted his primary care physician which subsequently prescribed oral famciclovir to be taken three times daily for 1 week. He says the pain has reduced since.
pt recv vax 10:00 26JUL96 & went home & went to sleep woke up approx 11:00 c/o h/a, vomiting;seen by MD 11:30AM;pt was a drowsy on arrival;no erythema sl tenderness in neck area on lt no redness or swelling;pt given suppository
COVID19 Vaccine Administered at wrong temperature; COVID19 Vaccine Administered at wrong temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07Jun2021 18:00 (Lot number: EW0178) at the age of 14 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2007 (ongoing); "Acid reflux", start date: 2020 (ongoing); "Lactose intolerant", start date: 2020 (ongoing); "Anxiety disorder" (ongoing), notes: 2016/2017. Concomitant medication(s) included: PANTOPRAZOLE taken for gastrooesophageal reflux disease, start date: 2020 (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma, start date: 2007 (ongoing). Vaccination history included: Bnt162b2 (First dose, Time: 15:00 , Anatomical site of injection: Right arm, Route of administration: Intramuscular, Lot Number: EW0179), administration date: 17May2021, when the patient was 14 years old, for COVID-19 Immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 07Jun2021, outcome "unknown" and all described as "COVID19 Vaccine Administered at wrong temperature"; ASTHMA (non-serious) with onset 2021, outcome "unknown", described as "asthma". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that his daughter was provided her second COVID-19 shot on 07Jun2021 and sent a letter to withheld which he copied Pfizer. The vaccine was given after held at the wrong temperature and also stated that it was not reported to the department of health nor CDC. He then reach out for help as he did not know what was the best course of action.  Updated information: Vaccination details lot number, time, Anatomical site, route of administration, vaccination facility address, concomitant drugs, patient medical history and relevant tests added.  Follow-up attempts are completed. No further information is expected.
On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Feb-2021, the patient experienced PAIN (Body Aches). On 21-Feb-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced ARTHRALGIA (Right Knee joint hurting). At the time of the report, PAIN (Body Aches), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and ARTHRALGIA (Right Knee joint hurting) outcome was unknown.            No relevant concomitant medications were reported  no treatment product was reported  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
My son recieved his 2nd hepatitis A shot Saturday morning ( June 12/2021) at around 10:15am, by 11am his breathing was hoarse/raspy. As the day continued he was very sleepy and had a low grade fever. On Sunday he was still very lethargic and had a generally  sick disposition as well as little to no appetite, all of these symptoms have persisted to effect him up until the priest time ( Monday  June 14 ,2021) I read that these ?side affects? are typical of this vaccine however he has never had this much of a reaction to past vaccinations and definitely not this severe and for as long.
Tachycardia; Director thinks it was an anxiety attack; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia) and ANXIETY (Director thinks it was an anxiety attack) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced TACHYCARDIA (Tachycardia) and ANXIETY (Director thinks it was an anxiety attack). On 10-Mar-2021, TACHYCARDIA (Tachycardia) and ANXIETY (Director thinks it was an anxiety attack) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. NO CONCOMINANT AND TREATMENT MEDICATIONS WERE USED.  Reporter denied to provide further information on any further vaccines   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional Info sig
hx: chest pain w/ allergy shots (birch, cats) tx w/ Xolair  presents w/ chest tight, headache, nausea
BODY ACHES; CHILLS; TIREDNESS; DIFFICULTY WITH WAKING UP; RIGHT SHOULDER PAIN; NOT FEELING WELL; This spontaneous report received from a patient concerned a 46 year old female. 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: 206A21A expiry: 23/JUN/2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced difficulty with waking up. On 12-APR-2021, the subject experienced right shoulder pain. On 12-APR-2021, the subject experienced not feeling well. On 12-APR-2021, the subject experienced tiredness. On 12-APR-2021 01:00, the subject experienced chills. On 12-APR-2021 06:30, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and tiredness on 12-APR-2021, and difficulty with waking up, and not feeling well, and had not recovered from right shoulder pain. This report was non-serious.
A report was received from a health care professional on 9/26/03 concerning a 33 year old female vaccinee who experienced metallic taste in her mouth, tightness in her throat, left arm numbness, left hand numbness and numbness of the fingers on her left hand two hours after receiving Fluvirin on 9/25/03. On 9/25/03, the vaccinee experienced metallic taste in her mouth, tightness in her throat and left arm numbness radiating to the hands and fingers. There was no wheezing or shortness of breath. The vaccinee received the injection to her left deltoid muscle. The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
On 11/21/00, had viral infection and had taken Zithromax for 5 days. On 11/23/00, symptoms worsened. On 11/25/00, client felt weak and tired and had taken sleeping pills to rest that night. On 11/26/00, still ill with "dizzy spells", vertigo and diplopia and nystagmus. Student returned to school on 11/27/00. On 11/28/00, dad picked up son from school and brought back home and then brought to hospital and admitted at 00:00 on 11/24/00. Treatment IV Ig on 11/28/00. Last treatment 12/3/00 and is still in the hospital Diagnosed with Guillain Barre syndrome
Patient reported symptoms of headahce, weakness and nausea starting at 1600 on the day of recieving the vaccine. Patient reported symptoms got worse over the course of 48 hours. Same symptoms with added body aches. Patient repoted right arm where injection was given was so sore she could hardly move arm. She also had low grade temp of 99.8
This spontaneous report as received from a licensed practical nurse refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-FEB-2017, the patient was vaccinated with M-M-R II subcutaneously (dose was not reported), (lot number L003855, therapy type unknown) that had expired on 05-FEB-2017, for prophylaxis. No adverse effects were reported. Additional information is not expected as there was no consent for contact.
intermittent side effects; feverish; chilly; strep. throat; tonsils were inflamed; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (intermittent side effects), PHARYNGITIS (strep. throat), TONSILLITIS (tonsils were inflamed), PYREXIA (feverish) and CHILLS (chilly) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PHARYNGITIS (strep. throat) and TONSILLITIS (tonsils were inflamed). On an unknown date, the patient experienced ADVERSE EVENT (intermittent side effects), PYREXIA (feverish) and CHILLS (chilly). At the time of the report, ADVERSE EVENT (intermittent side effects), PHARYNGITIS (strep. throat), TONSILLITIS (tonsils were inflamed), PYREXIA (feverish) and CHILLS (chilly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment medication include ibuprofen and colloidal silver vitamin .
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the mother of the reporter. The age at vaccination was not reported. The reporter stated that, his/her mother(patient) got shingles after getting the Shingle shot. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided. This is 1 of the 2 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205258:same reporter
Redness, edema, warmth, pain around injection site roughly the size of a large pear. Rash on bilateral arms and scattered on rest of body. Only treated with Tylenol.
0.5 mL dose administered instead of 0.3 mL dose Patient experiencing soreness in location of injection on 8/9/2021 but no other reaction
There is rash that left itchy bumps on my left arms, back and neck, but the worst is my left arm
The patient received the second dose of the vaccine too early.  She was 15 days out, not 21 days out.  This is our only reported event.
3/20/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  , she reports trouble swallowing   Assessment : Time of assessment 0521pm. ., no swelling of face or mouth area noted   Actions taken:  Observed for 30 minutes, VS taken , meds and water given       Medications administered: Famotidine (Pepcid) 10 mg by mouth. Time: 0515pm. Administered by ,.Benadryl 25 mg po x1, water given   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/20/2021  4:50 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER2613
Patient received pediatric vaccine and dose (0.2mL, 10mcg)  instead of the adult vaccine and dose (0.3mL, 30mcg).
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 14-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
ITCHING; PAINFUL; HIVES; RASH; MUSCLE ACHING; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's past medical history included high blood pressure, high cholesterol, 3 heart stents, and blood thinners, and concurrent conditions included allergy to x-ray contrast, occasional alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage and never had chicken pox or shingles. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 at 16:30 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced muscle aching. On 07-APR-2021, the subject experienced itching. On 07-APR-2021, the subject experienced painful. On 07-APR-2021, the subject experienced hives. On 07-APR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, painful, hives, and rash, and the outcome of muscle aching was not reported. This report was non-serious.
Pt complained of itching/burning at injection site.  No visible rash, redness or hives to site.  No wheezing or shortness of breath.  Patient given diphenhydramine 25mg po.  Pt assessed by provider and onsite EMS before leaving vaccination site.
pt recv vax & devel fever of 102, an inj site rxn, myalgia, arthralgias, h/a, nausea;tx w/Magsal tablets & recovered;
75y.o. male w/ complex medical hx including AFIB (on Xeralto), COPD, CAD, PAD s/p R BKA, DM, HLD, HTN, cervical stenosis(C3,C7 laminectomy with C4-6 laminoplasty with Dr on 11/10/2020), and lumbar stenosis with neurogenic claudication who presented to hospital as a transfer from facility on 7/3/2022 with surgical site leakage at the incision from his recent open L2/3 and L3/4 laminectomies and medial facetectomies (6/27/22). Patient was recovering well and had been in IPR until today when he was noted to be COVID positive.  General Surgery consulted today for small perineal pressure ulcer that was reportedly bleeding.  Patient states he feels fantastic and is frustrated he was transferred out of IPR for COVID.  He has a hx of multiple pressure ulcers, one on R hip, sacrum, and perineal region.  He states that he has seen bleeding before from his perineal wound, but not in a while.  No active bleeding now.  Denies any fevers/chills, CP, or SOB.  8/29 Medically stable for discharged to SAR. Facility is able to accommodate. Spoke with the facility and confirmed bed availability today.  Patient and his daughter aware and both are in agreement of the discharge plans.  Daughter to transport.
getting a weird ringing, buzzing noise in the ears that keeps coming and going; This is a spontaneous report from a contactable consumer (patient).  A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 17:00 (at the age of 55 years old), as a single dose (Dose 1) for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient got the Pfizer vaccine at 5PM "yesterday" (20Jan2021) and did fine. This morning (21Jan2021) at 10AM  she experienced getting a weird ringing, buzzing noise in the ears that keeps coming and going. She has never had this before. The clinical outcome of the event(s) was not reported. She wanted to know why she is getting this and if it was normal at this point.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
SEVERE SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe side effects. On an unspecified date, the patient died from severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210619563 - Covid-19 Vaccine Ad26.Cov2.S - Severe Side Effects. This event is considered Unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: SEVERE SIDE EFFECTS
Severe headache, mild arm pain, extreme fatigue, and brain fog. The headache subsided with advil after 12 hours.  Arm pain was 2 days, brain fog lasted around 65 hours, fatigue lasted 3 days.
Feels very achy; Muscle pain; Had an accident; hurt shoulder; still having pain where I had the vaccine; This is a spontaneous report from a contactable consumer (patient). An 87-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the Pfizer injection last Tuesday 12Jan2021, and the first day or so it was really okay but as the time has gone by it feels very achy. The patient was having some muscle pain. Other problem which patient reported that Pfizer have nothing to do was that patient had an accident and hurt shoulder. Both shoulders hurt now, other shoulder was not broken or anything, it just hurts and getting therapy for that. The patient asked if is it okay that patient was still having pain where the patient had the vaccine. Outcome of the events hurt shoulder and having pain where the patient had the vaccine was not recovered; for the other events was unknown.; Sender's Comments: The events "patient had an accident and hurt shoulder" are attributed to intercurrent conditions and assessed unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
3DEC98 c/o n/v & h/a;4DEC98 returned to school;
Two days after receiving my first Covid-19 shot, I went number from my belly button down. I can wal, just not feel. Looks like censory nerves are impacted but not motor nerves.Had MRIs and CR scans to see if it were something wrong with my spine and nerves. All came back clear. Both my GP and my chiropractor agreed that it is too coincidental to ignore that just two days prior was when I got my shot so it is probably a symptom. Advised me to report it so here I am.
2.5 x 4 cm Red, raised area. Warm to touch. Area developed immediately after giving vaccine.
Irregular increased heart beats and faster heart beats; Irregular heart beats; Increased chest discomfort; Coughing; Disruption of speeches; Affected sleep; This is a spontaneous report from a contactable consumer, the patient. A 52-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 13Apr2021 at 12:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 medication included unspecified blood thinner, for an unknown indication from an unknown date and unknown if ongoing. On 18Apr2021, the patient began to experience irregular increased heart beats, and faster heart beats, increased chest discomfort starting about 5 days following the first dose of shot. It happened throughout the day. It happened during seating and sleeping. The irregular heartbeats and chest discomfort caused coughing and disruption of speeches. It began to become severe and affected sleeping. The events resulted in doctor or other healthcare professional office/clinic visit. On 18Apr2021, the patient underwent heart rate test and the result was increased. It was unknown if the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular increased heart beats and faster heart beats, increased chest discomfort, coughing, disruption of speeches and affected sleep was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.