chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature around 97 degrees.  Adverse Events: Sore throat, fatigue, enlarged right tonsil, and minor ear discomfort (such as when one has ear infection).  Events still occur more than 72 hours after FluMist administered.
This spontaneous case, initially received from other non-health professional on 24-Sep-2018, concerning a 35-year-old, adult pregnant female patient. There was no maternal and paternal medical history (relevant to pregnancy). The patient did not take any medications prior to and during pregnancy. The patient's husband did not take any medications prior to conception. The patient did not use any contraceptive methods. On 24-Sep-2018, the pregnant patient (reported as first pregnancy) was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252230 (as reported 252130) and expiry date: not reported). It was reported that, the patient's foetus did not experience any adverse event after the vaccination. The patient's estimated delivery date was 31-Oct-2018. The reporter assessed this case as non-serious.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 12:00 as dose 1, single (Lot number: EN6202), in left arm and on 23Mar2021 at 12:00 as dose 2, single (Lot number: ER2613), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Dec2021 as dose 3 (booster), single (Lot number: 030h21b), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "known allergies: airborne allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (27May2022) Negative; (30May2022) positive, notes: Had Covid rebound. Tested positive again 3 days after testing negative and started having symptoms again. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.
The day following vaccine pt reported fever 101.3-100.5 -> following day 100.5. Near syncope off & on x 2 days. H/A, 'generalized achiness', nausea, decreased appetite, shakiness x 3-4 days.
Redness & slight swelling around injection site, itchy at site only.  BENADRYL q 6-8 hours.
wheezing Tx with albuterol and benadryl 25mg IM x 1. Sxs resolved within 15 mins
Much pain and stiffness from the waist down moving from place to place lasted for 5 days and some continued stiffness for 5 more days but not nearly as severe
Information has been received from a registered nurse concerning a who was vaccinated with a single dose of Zostavax (Oka/Merck). It was reported that the patient developed an injection site swelling after vaccination. The swelling resolved with ice. Additional information has been requested. This is one of the several reports received from the same source.
Fell getting out of bed.  Cat scan and x-rays on head and neck.  6 stiches in upper lip with a bruised knee and whip lash symptoms.
36hrs p/vax pt had 5-6 hrs period of acting somewhat spacey & having dec grip reflexes; No significant crying, irritability, or fever; Acted & appeared nl since then;
19 yo female reported to her father she was not feeling well after receiving Janssen vaccine at 15:00. Father flagged observation nurse over as patient displayed a syncopal episode. Client reported her vision went black but did not recall if she lost consciousness. Client became alert without assist. BP 72/50; client appeared pale client given gatorade and reported feeling better BP 100/50 client finished observation and was ambulatory upon leave with father
On 02/07/05, patient received varicella vaccine at 1:00 p.m. On 02/06/05, began a low grade fever, one papular lesion on face at 6:00 a.m. Babysitter called mother at noon, temperature increased to 103 degrees and child was seen at 1:00 p.m. by pediatrician. At that point child had several lesions, macular-papular rash at different stages on face, stomach, neck, back, buttocks and listlessness. Treated with pedialite and motrin for fever. No Known exposure to chicken pox. Improving on 02/17/05.
After the vaccination, my right shoulder was feeling numb, and I had pain as well. I had motion in my arm it just didn?t feel good. It started to progress over to my shoulder and neck within a month. I went to the doctor, and she told me to go to physical therapy. I haven?t gone to many times to see progress.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history and concurrent condition was not reported. On an unknown date, the patient was vaccinated with MMR II. No information on concomitant medications was provided. On an unknown date, the patient developed rash on an unspecified part of the body during an unknown period of time after receiving MMR II. The outcome of the event and the relatedness of the event with the suspect drug was not provided. Additional information has been requested.
Vaccine given on 1-26-06. In the evening, mom noted some pinkness & felt warm at site right thigh. This AM (1/27) the thigh site was redder, hot, with mild swelling. Pt c/o pain when walking. Pt seen approx 11 am swelling, redness subsiding;pt walking well, although site is still tender to the touch. Tylenol and warm packs advised.
Shortly after vaccination small raised bumps formed on both forearms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 02Sep2021 (Lot number: EW0185) at the age of 26 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Sensitive skin" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "eczema" (unspecified if ongoing), notes: eczema (usually form hives versus small bumps). There were no concomitant medications.  The following information was reported: PAPULE (non-serious) with onset 06Sep2021, outcome "not recovered", described as "Shortly after vaccination small raised bumps formed on both forearms". Therapeutic measures were not taken as a result of papule.  No follow-up attempts are possible. No further information is expected.
Patient was given Pediarix instead of Pentacel, therefore she received Hep B, but not Hib. No reactions noted.
Day 1-7: Headache, fatigue, dizziness, tinnitus, severe cramping in feet, foot pain, menorrhagia Day 8: Syncope, lightheadedness, tinnitus, numbness and tingling in left foot and left hand, metrohaggia Day 8-30: Headache, dizziness, tinnitus, left foot swelling, foot pain, numbness and tingling in left hand and foot, polymenorrhagia Day 26-27: Epistaxis, headache, fatigue, dizziness Day 28: CT scan detected layering fluid in the posterior left ethmoid air cell
11/3 blood clot was found in my right leg.  I wanted to know if there is any documentation related to people having blood clots after receiving Pfizer.  My doctor is not able to explain why the blood clot occurred.
On July 11, 2022, she had a seizure for the first time ever and was transported by ambulance to local hospital.
Had Typhoid injection on 5/24/07 at 0830. Called clinic with symptoms of chest pressure and cough at 1150. Denied SOB. Instructed to F/U in ER and did so.
Patient (DOB: 09/11/1996) received the 1st COVID vaccine (Pfizer, lot #: ER9729, expiration date: 04/07/2021) at 1145. EMT observed the client looking distressed and uncomfortable, so he approached her in the observation seating area around 1150. Patient expressed ?tightness in chest? and ?felt like she was going to black out, about 1 minute and 30 seconds into her 15 minute observation period.? EMT gave the client a water bottle and made sure it was safe to move the client, before transferring her into the zero- gravity chair.RN, PHN responded next. Client stated she has no known allergies, has no medical conditions to be aware of, and has no previous reactions to any other vaccines. First set of vitals were taken at 1153 while client was sitting; client was alert and oriented, Blood Pressure (BP): 112/88, Heart Rate (HR): 108, Respiratory Rate (RR): 28, skin was warm, dry, tact and normal for ethnicity, capillary refill was within normal limits. Nurse observed the client?s hands to be shaking. Client was then advised to stay an additional 30 minutes by the EMTs for further observation- client agreed. Client reported the feeling of tightness in her chest resolved around 1156. She also expressed that ?she had never had a panic attack before and that the medical environment made her feel uneasy because she does not like needles.? Second set of vitals were taken at 1158 while client was sitting; client was alert and oriented, Blood Pressure (BP): 100/65, Heart Rate (HR): 64, Respiratory Rate (RR): 20, skin was warm, dry, tact and normal for ethnicity, capillary refill was within normal limits. Nurse observed the shaking in the client?s hands had resolved. Last set of vitals were taken 1223 while client was sitting; client was alert and oriented, Blood Pressure (BP): 110/70, Heart Rate (HR): 60, Respiratory Rate (RR): 17, skin was warm, dry, tact and normal for ethnicity, capillary refill was within normal limits. After this set of vitals, the client stated she ?was feeling way better.? Nurse educated client on the importance of eating and hydrating before she receives her second dose and that if she had additional symptoms or questions to call her provider. Client walked out the vaccine site with a steady gait.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 03-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Allergies got pretty bad after the first dose, probably a week and a half afterwards; Cough; delayed reaction; This is a spontaneous report from a contactable consumer (Patient). A 28-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 21Dec2020 08:30 (Batch/Lot Number: EJ1686) as SINGLE DOSE for covid-19 immunisation. Medical history included Allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were reported as none. The patient had no family medical history. The patient did not receive any other vaccines on the same day of suspect vaccine. Caller was reporting he had a delayed reaction to the Covid vaccine (Dec2020). He saw his allergist and primary care provider. The primary care informed him that she had 2 other patients who this has happened with and they had rashes. Unable to provide any further details about the 2 other patients. Mentioned he also gets allergy injections. Also had the second one and his allergies were much worse. Allergies got pretty bad after the first dose, probably a week and a half afterwards. He also had a cough. He got the second dose and didnot think much of it and his allergies. Knows some have allergies worse than others. He ended up having flu like symptoms 12 hours afterwards and cough. It's been a month and he still has cough. The day before yesterday he had a lot of breathing issues that were so bad he had to get a updraft of Albuterol to help. Yesterday he saw the primary care provider and she gave him a steroid injection and it seemed to help quite a bit also. He still has some other minor issues, but they were not so bad. Outcome of the events allergy to vaccine and cough were not recovered and unknown for other event.  Follow-up attempts are completed. No further information is expected.
received a dose of expired ACTHIB with no reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 1 years old male patient who received a dose of expired acthib with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) for immunisation.  On 22-Jun-2022, the patient received suspect HIB (PRP/T) vaccine at a dose of 0.5 ml (lot UJ513AD, expiry date, form) via unknown route in the left thigh for immunisation.  On 22-Jun-2022 the patient developed a non-serious received a dose of expired acthib with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) vaccine.  Reporter wanted to know if the patient need to be revaccinated.  Action taken: not applicable.   Outcome: Unknown.    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 guidelines. 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.
C/O "feeling tired and warm." Responsive but drowsy. Breathing clear. Vitals stabilized. no other s/s. Laid down on cot to rest @11:55. C/O "head hurts" d/t hitting metal part on cot. No bump or bleeding, gave ice pack x2 for comfort. Denies dizziness. Sat up @11:59 verbalized felling less tired. Appeared more alert. Ambulated without assistance  @12:02. "Felling okay" after moving around. Water offer and accepted. Patient will call son to pick up.
Patient received 200 mcg  of Moderna vaccine instead of 100 mcg Patient notified and advised to call our office if adverse events occur
pt devel diffuse erythema rt upper arm, beginning w/quarter sized area of erythema & edema 3hr p/vax;
Started with soreness in arm and expanded to shoulder joint the next morning. This persisted an got worse for each of the next three days. Muscle soreness then began to abate on the fourth day, but shoulder and elbow got more sore and stiff. Now, 11 days after the vaccine, most general soreness is gone, but shoulder remains stiff with a loss of full motion without causing pain.
complains of dizziness s/p 2nd dose vaccine. drank 1 cup of water, after 10 minutes patient verbalized relief of dizziness. stayed for 20 extra minutes for monitoring then left
Receiving dose greater than 12(US) hours post puncture: 04Feb2022 2:15 PM; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving dose greater than 12(US) hours post puncture: 04Feb2022 2:15 PM) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025l21b) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving dose greater than 12(US) hours post puncture: 04Feb2022 2:15 PM). On 04-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Receiving dose greater than 12(US) hours post puncture: 04Feb2022 2:15 PM) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP would like to know the validity of the doses and if the patient should be revaccinated, what to do next Dose administered 12 US 24 CA hours post puncture. Date the vial was initially stored in the refrigerator 8 PM 02 Feb 2022. Date s and time vial was first punctured 03Feb 2022 3PM. Date and time of administration of vaccine 04Feb2022  2:15 PM Total amount of time the vial was exposed to room temperature range 8 to 25 C= 46 to 77 F: 25 hours exposed to room temperature.  No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
A report has been received from a Pharmacist concerning a 5 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that expired product was administered to the patient. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious.
White bumps/whiteheads/bumps with white pimples inside; swelling mostly to the upper lip; This is a spontaneous report from a contactable consumer or other Non-health care professional. This report is based on the information received by Pfizer from Galderma (Reference: GL-061621-14617).  A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27Feb2021 (at the ag of 48-years-old) as dose 2, single for covid-19 immunization. Medical history included allergies to sulfa, Ibuprofen and aspirin. She had Juvaderm in Feb2021. The flu shot in the fall of 2020. Concomitant medications included hyaluronic acid (RESTYLANE) taken from 27May2021; botulinum toxin (BOTOX) type a from 27May2021; probiotics; loratadine (CLARITINE); cetirizine hydrochloride (ZYRTEC). The patient previously took ibuprofen and experienced drug hypersensitivity, aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, juvederm, BNT162B2 (formulation: solution for injection, Batch/lot no was not reported) via unspecified route of administration on 06Feb2021 as dsoe1, single for covid-19 immunization. On 31May2021, the patient experienced white bumps/whiteheads/bumps with white pimples inside, swelling mostly to the upper. Patient sister stated that the patient had Restylane injected into her lips on 27may2021. On 31May2021 begin having a reaction looks like whiteheads/bumps with white pimples inside and swelling mostly to the upper lip. Patient saw the injecting HCP and gave her Prednisolone, then reporter went back again two days ago and he gave her Hylenex injection 60 units but it did not help the patient. The patient had no illness recently and no dental procedures in the last 6 to 12 months. Therapeutic measures were taken as a result of white bumps/whiteheads/bumps with white pimples inside (skin disorder), swelling mostly to the upper lip (lip swelling). The outcome of the events was recovering.  Information on the lot/batch number has been requested.
This spontaneous report as received from a physician an office manager refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 05-JUN-2015 the patient was vaccinated with an improperly stored dose of MMR II lot # K014833, expiration date 14-SEP-2016 (dose, dose number, route and anatomical locations were unspecified). Concomitant therapies were not reported. On 24-JUN-2015, the patient was revaccinated with an unspecified lot of MMR II. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Dizziness; slight boost of energy, started to feel better; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and THERAPEUTIC RESPONSE UNEXPECTED (slight boost of energy, started to feel better) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B12A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia since 2009, Thyroid disorder NOS, Penicillin allergy, Milk allergy, Food allergy and Latex allergy. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for Thyroid disorder NOS.   On 01-Mar-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021 at 10:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (slight boost of energy, started to feel better). On 29-Mar-2021 at 11:00 AM, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) and THERAPEUTIC RESPONSE UNEXPECTED (slight boost of energy, started to feel better) had resolved.             No treatment medications were reported.   This case was linked to MOD-2021-404475, MOD-2021-406423 (Patient Link).
This child was given H1N1 flu mist, even though he was not quite two years old.
Slept a lot; Slurring when he spoke; Felt nauseated; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept a lot), DYSARTHRIA (Slurring when he spoke) and NAUSEA (Felt nauseated) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease. Concomitant products included AMANTADINE, PREGABALIN, AMITRIPTYLINE, CARBIDOPA and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced SOMNOLENCE (Slept a lot), DYSARTHRIA (Slurring when he spoke) and NAUSEA (Felt nauseated). On 05-May-2021, SOMNOLENCE (Slept a lot), DYSARTHRIA (Slurring when he spoke) and NAUSEA (Felt nauseated) had resolved.        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.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: TCR : Outcome of event resolved.