chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very red circle around injection site; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the left arm on 05Jan2021 16:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included anxiety. The patient has no known allergies. The patient had no covid prior vaccination. The patient was not tested for covid post vaccination. The patient is not pregnant at the time of vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), curcumin, vitamin b12, vitamin c (also known as ascorbic acid), vitamin d, and biotin. The patient did not receive other vaccine in four weeks. On 16Jan2021 at 12:00 (also reported as day 12; possibly discrepant), the patient experienced very red circle around injection site. The patient did not receive treatment for the reported adverse event. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
This case was reported by a physician via call center representative and described the occurrence of general body pain in a 69-year-old male patient who received SHINGRIX (batch number E927Z, expiry date 27th February 2021) for prophylaxis. On 11th September 2018, the patient received the 2nd dose of SHINGRIX. On 12th September 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain, tiredness, pins and needles and skin tightness. On an unknown date, the outcome of the general body pain, tiredness, pins and needles and skin tightness were not recovered/not resolved. It was unknown if the reporter considered the general body pain, tiredness, pins and needles and skin tightness to be related to SHINGRIX. Additional details were reported as follows: One day after vaccination, the patient developed diffuse body pain, feeling tired, feeling of pins and needles, and skin feels tight and stretched. The patient stated the symptoms were worse in the afternoon and were ongoing since 12th September 2018. The healthcare professional not convinced this was at all related to SHINGRIX, but patient requested the call. The reporter consented to follow up.
Pt presented 2 days later with SOB but was stable and discharged stable without oxygen requirement.
Approximately 1 hour after administration of injections, Mom presents back to clinic with child covered with red rash, small raised bumps and wheezing. Gave 01.cc 1/1000 epi SQ.
Red fine pinpoint rash beginning on face, ears and around ears. Spread down body, occasional macropapular none weeping spots. No rash on hands or feet. Temp 99.7 ear.
Morning After Vaccine up until this report: Red rash, swelling of arm with itching, large bump at injection site.  I can send a picture if you would like.
Tired a lot / fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Feb2021 (Lot number: EL9262) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Restless legs syndrome", start date: 2001 (ongoing); "high blood pressure", start date: 2006 (unspecified if ongoing); "High cholesterol" (ongoing), notes: High cholesterol; "Factor V Leiden" (ongoing); "Weak bones" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for factor v leiden carrier (ongoing); CLONAZEPAM taken for restless legs syndrome, start date: 2001 (ongoing); GABAPENTIN taken for restless legs syndrome, start date: 2001 (ongoing); STALEVO [CARBIDOPA MONOHYDRATE;ENTACAPONE;LEVODOPA] taken for restless legs syndrome, start date: 2001 (ongoing); TRAMADOL taken for restless legs syndrome, start date: 2016 (ongoing); PRAVASTATIN taken for blood cholesterol increased, start date: 2006 (ongoing); AMLODIPINE taken for hypertension, start date: 2006 (ongoing); VITAMIN D [COLECALCIFEROL] taken for bone disorder (ongoing). The following information was reported: FATIGUE (non-serious) with onset 04Feb2021, outcome "recovered" (11Feb2021), described as "Tired a lot / fatigue". Additional information: It was reported that the patient was typically tired a lot because she doesn't do anything after the first dose; patient slept better. It was reported that the patient experienced fatigue from 04Feb2021 to 11Feb2021; however, it was also reported that the event lasted for 6 days (possibly discrepant). The patient has been diagnosed 22-23 years ago for other conditions. The patient has been taking Aspirin for 22-23 years and Vitamin D for 5-6 years. The patient has no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations within 4 weeks and no relevant tests.  No follow-up attempts are possible. No further information is expected.
Vaccinated with J&J vaccine for Covid in June, 2021.  Symptoms started 12/22/2021 - sore throat, myalgia, fatigue.
Td was administered to a 6-year-old male patient after being bitten by a dog.
had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month, vaccine was administered/ no adverse event; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant).  This case is linked to cases 2019SA166192, 2019SA166193, 2019SA164978, 2019SA166195 and 2019SA166196, same reporter.  This case involves a 31 years old patient (gender unknown) who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given.   On 22-May-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6141AB, expiry date 15-Dec-2020 via intramuscular route in the left deltoid.  It was an actual medication error due to incorrect product storage.  It was reported that had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Expired flu vaccine given -injection in box removed and administered-expiration date not checked prior to administration.
received covid vaccine (moderna) in 2-3/2021, then received covid-19 booster on 12/15/21.  Skipped on dose of rivaroxaban 10mg daily (which he was on to prevent blood clots) and stopped aspirin.  3-4 days later developed leg swelling.  had Extensive left leg DVT involving the left iliac, common femoral, femoral, popliteal, and all 3 deep calf veins.  Rivaroxaban dose was increased.
Patient was not appropriate age to receive the Moderna vaccine. Patient's mother was notified. No allergy or adverse reaction reported from patient via patient's mother. Mother told by myself that second dose of vaccine will need to be Pfizer.  Myself spoke with clinical and provider outreach specialist.
she has patients who only receive one dose and are curious about how protected from Shingles they are; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced incomplete course of vaccination (Verbatim: she has patients who only receive one dose and are curious about how protected from Shingles they are). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-JUN-2023 The reporter would like to know what is the efficacy of Shingrix is for one dose only.  She stated that she had patients who only receive one dose and are curious about how protected from Shingles they are. The vaccine administration facility is the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Details pertains to 1st dose of Shingrix in product tab.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 21-AUG-2018, the patient was vaccinated with an improperly stored M-M-R II lot # N023146, expiration date: 24-AUG-2019 (exact dose, route and site of administration were not reported) for prophylaxis. The vaccine was diluted with an improperly stored sterile diluent (manufacturer unknown) lot# N030026 (also reported as #030026), expiration date: 04-JUN-2020. The vaccine and sterile diluent were exposed to temperature in the range of 9 degrees Celsius to 25 degrees Celsius for 13 days. Temperature excursion was not detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1809USA001804: US-009507513-1809USA001805.
Green emesis and green liquid diarrhea. Weakness, fatigue and hot flashes. Stomach cramps.
The day after my vaccine went into A-fib and had to go home then on Saturday 01-23-2021 the A-fib was gone
C/O fever over w/e. (+) cong & cough for past 2 days with red spots showing up, some look like blisters (+) itchy.
Flat, erythematous, itchy rash to bilateral arms, chest, neck, and L ribcage
Left arm is still a little tender; Left arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm is still a little tender) and VACCINATION SITE PAIN (Left arm was a little sore) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Clotting disorder (Diagnosed on 2009 or 2010). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL PALMITATE, RIBOFLAVIN, THIAMINE MONONITRATE (MULTIVITAMIN 6) for an unknown indication.    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 VACCINATION SITE PAIN (Left arm was a little sore). On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm is still a little tender). At the time of the report, VACCINATION SITE PAIN (Left arm is still a little tender) and VACCINATION SITE PAIN (Left arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.
fever; weakness; feeling bad; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for 1st dose refer case US2019118455).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, weakness and feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, weakness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the fever, weakness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller was husband of the patient who received dose of Shingrix. The patient experienced fever, weakness, feeling bad that resolved after a few days. It was reported that these events were about half as bad with the second dose.
Severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27May2021 at 12:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 29May2021 at 12:00, 48 hours after receiving vaccine the patient experienced severe headache. Pains did not stay all the time but instead pains hit the left back of patient's head every 3 to 5 seconds. Patient reported that the pains lasted at least 36 hours. Patient took 2 Tylenols every 8 hours to relieve the pains. Patient had minor headache 2 to 3 more times last week but they did not last long. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with 2 tylenols. The clinical outcome of the event severe headache was recovering 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.
She came in for labs and for a Gardasil vaccination. She was vaccinated, and then while having labs drawn, she became lightheaded and fainted. Mother reports that she was having seizure like shaking while she was out. She did not hit her head, it was a very short period before she responded, was slightly pale, but otherwise herself. No postictal changes. BP low in the 70's initially. She had some ginger ale and cornbread and responded well. After about half an hour she had an excellent BP of 110/70. BP remained stable free standing and walking out.
COVID arm. Red, swollen, itchy arm at injection site 8 days after injection.
Pt received both of her vaccines on 5/15/2023. Pt tolerated vaccines well in room with nurse and mom. When asked by RN pt stated she feels fine and has no concerns other than some arm soreness. Mom and pt walked out of room, up to the receptionist check out desk, where pt then passed out. Per mom, pt tapped mom on the shoulder and told her, while at the check out desk, that she did not feel good, mom said she looked at the pt. Her faced drained of color and turned white and then she passed out and fell on the ground. Immediately 3 nurses and Dr. came to the side of the pt and mom.  Vitals- BP, HR, O2 were checked. Pt told to lay on the ground still. Calmed mom and pt down during this time. Re-checked BP, HR, O2 - 5 minutes later. Pt able to slowly sit up, and was put in a wheelchair, and taken to a room in the office, where she was monitored for another 20  minutes. Pt given graham crackers and orange juice, as she had not eaten anything in the morning. During the 20 minutes BP taken 3 more times within defined limits. At the end of the 20 minutes pt felt better and was able to walk out of the office to her and mom's car.
about 7 or 8 min after administration patient felt pain in the back of her neck going up to the base of her head, an associate monitored her from that point, a few min later she became very woozy/drowsy and her eyes were glossy and her lips purple/blue and face pale, we moved the patient to the floor atop a mat/blanket and propped her feet on the chair, after a few min her color came back to her face and lips, at some point her forehead began to tingle and her head started to hurt, the tingling began to move down the brim of her nose and within a few min the color left her face and lips became purple/blue again, the tingling then went further down her nose and down the side of her face, at that point I called EMS in fear it may turn into an allergic reaction, afterwards she said her throat felt "numb", her state remained the same until EMS arrived, note patient never lost consciousness nor reported difficulty breathing or swelling, no medications were administered at the pharmacy, EMS took the patient to the hospital, administered something for her headache and dizziness, performed a CAT scan that showed no significance, and sent her home advising her to followup with her provider in a couple days
Significant chills; Spiked a fever (100 F at peak); Night sweats; Joint/muscle aches; Joint/muscle aches; This is a spontaneous report from a contactable healthcare professional (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported), intramuscularly on the left arm on 19Jan2021 (18:00) at a single dose for COVID-19 immunization at the public health clinic. Medical history included diabetes type II, asthma, high cholesterol and sulfa allergy. Concomitant medications included metformin, montelukast, finasteride, atorvastatin, cetirizine and fluticasone propionate (FLUTICASON). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported), intramuscularly on the left arm on 28Dec2020 (when the patient was 38 years old) for COVID-19 immunization. On 20Jan2021 (06:00), the patient had joint/muscle aches. On 20Jan2021 (19:30), the patient had significant chills for "about 15 minutes"; had spiked a fever (100 F at peak); and had night sweats. The patient had not receive any treatment for the reported events. The outcome of the events was recovered in Jan2021 for 'joint aches', 'significant chills' and 'night sweats'; was recovered on 21Jan2021 for 'spiked a fever'; and was recovering for 'muscle aches'. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
Dizziness, Headache, Sedation, Myalgia, Fever, CoughWheeze & Constipation Narrative:
Two days after the vaccine I woke up in a cold sweat, clammy, nauseous. Felt very weak. Sat on the bathroom floor until the feeling passed, about 10-15 minutes. After that I had something to eat and felt ok.
vial was stored outside of parameters, spoke to manufacturer and determined that patient is safe and revaccination is not recommended. called pt and they are ok.
Information has been received from a physician concerning a 16 year old female patient who on 22-MAY-2007 was vaccinated IM with a first dose of Gardasil (Lot# "0170U"). Concomitant therapy included a dose of Menactra. Within fifteen minutes, the patient "passed out cold." Unspecified medical attention was sought. Subsequently, the patient recovered and was fine. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from a medical assistant concerning a 17 year old female patient with no known allergies who on 22-MAY-2007, was vaccinated IM into the right deltoid with a first dose of GARDASIL (Lot# 655620/0171U). Concomitant therapy included a dose of MENACTRA. Ten minutes after administering the vaccination the patient fainted and "passed out cold." It was reported that the patient was in aura for about 20 minutes after fainting. Unspecified medical attention was sought. The patient recovered and was fine from "passed out cold." On 22-MAY-2007, the patient recovered from fainted and aura. No product quality complaint was involved. Additional information is not expected.
About a month ago, I was coming up the stairs and I got short winded I had to stop and keep stopping and it started after that. If I go the restroom from my bed, I get short winded. Talking makes me short winded. I am not as bad as I was at first, but I am still having shortness of breath. I went to the Emergency Room on April 14, 2023, because I thought it was my heart. The tests they took on my heart came out negative. I do not know what caused it. They did blood work, chest X-ray, Echocardiogram. They checked for any blood clots in my legs the results were negative.
Patient reports he developed a lump under his skin about 5cm x 5cm immediately after the injection. Over the next few days the lump got smaller then about 3 days after the injection started getting worse again. Today, 10 days post-injection, he presented to our clinic with a large area of induration measuring 7cm x 10 cm with a dark red center measuring 2 cm x 3 cm.
BRIEF OVERVIEW: Discharge Provider: Primary Care Physician at Discharge:  Admission Date: 9/8/2023  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Severe sepsis [A41.9, R65.20] Acute respiratory failure with hypoxia and hypercapnia [J96.01, J96.02]   HOSPITAL COURSE: 4-year-old male with history of AV malformation with prior hemorrhagic stroke and subsequent tremor, non-insulin-dependent type 2 diabetes, paroxysmal atrial fibrillation status post Watchman procedure, BPH, neurocognitive disorder.  Patient had been residing in a skilled nursing facility on hospice care.  He was diagnosed with COVID-19 about 10 days prior to admission.  Patient was brought to the emergency department with concerns of acute encephalopathy.  He appeared septic.  CTA chest concerning for extensive bilateral nodularity, ground-glass, areas of multifocal consolidation consistent with multifocal pneumonia.   Patient has a court-appointed guardian and emergency department physician was able to get in touch with her, and she agreed that patient would want to revoke his hospice for hospitalization, but with no aggressive measures.  Patient was initially placed on BiPAP for increased work of breathing.  He was started on broad-spectrum antibiotics.  During the next 24 hours, patient showed very minimal improvement and after further discussion with his guardian on 9/10, patient was made comfort measures
No additional adverse events have occurred; patient was administered GARDASIL 9 intramuscularly in right glute; This spontaneous report was received from a nurse and refers to a 29-year-old female patient. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.     On 09-SEP-2021, the patient was vaccinated with a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly in the right glute (product administered at inappropriate site), 0.5ml milliliter,  lot # T030746,  expiration date 16-MAR-2023 for prophylaxis. No additional adverse event and no product quality compliant were reported.
Started with a fever and flu-like symptoms; did not feel well; experienced intense stomach pains; went to Urgent Care; then another hospital later, then specialist, then to Hospital (over time).
On 10/6/17 woke up from nap and could not rise. Had worse case of vertigo. World was spinning. Called Doctor. Ambulance took me to Hospital.
pt recv vax 1APR99 & 4APR99 pt exp vomiting, diarrhea & a fever;pt became dehydrated on 5APR98 & was hosp w/gastroenteritis; 8APR99 pt was discharged;