chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FELT KINDA SICK THE NEXT DAY; This spontaneous report received from a patient via a company representative concerned a male 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced felt kinda sick the next day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt kinda sick the next day was not reported. This report was non-serious.
Appendicitis, appendectomy (gangrenous, perforated), recovery - pain management, antibiotics
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 18 year old female patient with no pertinent medical history, drug reactions or allergies. The reporter stated, that on 13-SEP-2012 a patient received a dose of VARIVAX (Merck) (lot# reported as: H007450 with expiry date: 27-MAR-2014) and later, on an unknown date in 2-12 she was pregnant. On 13-SEP-2012 the patient also received an unspecified meningococcal vaccine (manufacturer unspecified). The patient became pregnant with LMP (last menstrual period) of 01-AUG-2012 and EDD (estimated delivery date) of 08-MAY-2013. Initial exposure to VARIVAX (Merck) was at 6 week. The pregnancy outcome was not reported. There was no treatment given for the adverse event. In 2012 (exact date unspecified) pregnancy test was done and the patient was pregnant. On 13-SEP-2012, PPD (tuberculosis skin tests) was performed, results not provided. The patient sought unspecified medical attention. No further information is available. Additional information is not expected because the reported did not have more information. Concomitant was added. Laboratory studies were corrected. Information regarding pregnancy information were corrected. Narrative was updated. Closing statement was changed.
This case was reported by a nurse to a sales representative and described the occurrence of injection site burning in an adult patient who received Hep-B.   On an unspecified date, the patient received a dose of Energix-B in the arm.  At an unspecified period of time following the vaccination on the same day, the patient experienced an injection site reaction characterized as burning.  The nurse considered the injection site reaction to possibly be related to vaccination with Energix-B.
Headache 9pm Body aches and chills at midnight Body aches, fatigue day after  Rash developed from neck down to thighs and red ring/rash at injection site 2 days after injection.
Rash starting around mouth. Then redness of entire face and ears. Given BENADRYL po in office and Prednisone po in office 11-16-09. Given sample of Prednisone and cont BENADRYL prn. Mom held steroid 11/17/09.
22 y/o pregnant female, ADSM, reports receiving Flu Mist vaccine on 17 October 2008 despite being 38 weeks gestation. The service member decided to call the VHC for further information on the risks of the vaccine to her baby.
SINUS PRESSURE; HEADACHE; NECK PAIN; BACK PAIN; JOINT PAIN/STABBING FEELING WITH JOINTS; LOW GRADE FEVER; This spontaneous report received from a patient via other company (AbbVie) concerned a 59 year old female of unspecified race and ethnicity. The patient's weight was 175 pounds, and height was 65 inches. The patient's concurrent conditions included: tobacco user, smoker (cigarettes a pack every three days (started 1978)), and abstains from alcohol. The patient had no known drug allergy. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, (dose number in series was 1), administered 1 in total on MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events (Dose number in series was 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, (Dose number in series was 2) administered 1 in total on 12-JAN-2022 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 12-JAN-2022, the patient experienced low grade fever. On 25-JAN-2022, the patient experienced neck pain, back pain, and joint pain/stabbing feeling with joints. On an unspecified date, the patient experienced sinus pressure, and headache (Dose number in series was 2). Treatment medications (dates unspecified) included: fexofenadine hydrochloride, and loratadine/pseudoephedrine sulfate. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry was not reported) dose was not reported, 1 time every 2 weeks, from MAR-2021 for rheumatoid arthritis Concomitant medications included docusate sodium for bowel movement, influenza vaccine for flu vaccination, tizanidine for muscle relaxer, and hydrocodone bitartrate/paracetamol for pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from low grade fever on 14-JAN-2022, was recovering from sinus pressure, and headache, and had not recovered from joint pain/stabbing feeling with joints, neck pain, and back pain. This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (had a reaction to report) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (had a reaction to report). At the time of the report, ADVERSE REACTION (had a reaction to report) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.No treatment medications were reported.
5 days after the injection,a dark red hard spot 2-3 inches in diameter came up. Itchiness and hotness,this has been the 3rd day since it started,so far it's getting larger
Body itching, eyes swollen shut, red itching eyes, stomach aches, body aches, cough hoarness, sore throat, runnning nose.
Redness and warm to the touch since 10/15/11. Staying the same reaction.
+- 30 minutes after the shot I felt very woozy and my vision became impaired. Since then I have ongoing intermittent numbness/tingling/itching/inflamation in face/head/arms/mid-spine, a drooping right eye, headaches/pressure, blurry/impaired vision, light sensitive eyes (feels like theres sand in them) and dizzy spells. At Urgent Care the doctor diagnosed me with "Facial Paresthesia and adverse effects of vaccine." He sent me to the ER where blood clots/stroke was ruled out. They referred me to a neurologist for next week Friday. I also had a few days of excessive thirst,  unusually heavy menstrual cycle and a week of a pain above my right elbow. My symptoms have persisted for 11 days and counting.
This spontaneous report as received from a pharmacist refers to a 50 year old female patient with no pertinent medical history and no drug reactions or allergies who on 08-JAN-2014, was vaccinated subcutaneously with a single dose of ZOSTAVAX (lot number J011333, Exp. Date: 13-DEC-2014) in the left arm. It was reported that on 09-JAN-2014, the patient developed swelling and redness at the injection site. Hydrocortisone cream was given as a treatment for the experience. No lab diagnostic studies were performed. At the time of the report, the patient had not recovered. The relatedness for redness and swelling at the injection site and ZOSTAVAX was unknown. Additional information is not expected.
Information has been received from a registered nurse concerning a 6-month-old patient who on 24-AUG-2006 and 10-JAN-2007 was vaccinated PO with the first and second doses, respectively, of Rotateq. It was unknown if medical attention was sought. No problems were reported. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to 19 unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates in 2017, after 15-JUN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # M041766, expiration date 08-MAY-2018 (strength, dose and dose number were not provided) for prophylaxis. On an unspecified date, the vaccines were exposed to temperature ranges between 32° Fahrenheit (F) to 35° (34.7°F) one cycle during a time frame of 12 hours. There was not previous temperature excursion, the temperature excursion was called by a data logger. Adverse effects were not reported.
Cold like symptoms; bloody nose at least once a day; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 04Mar2021 at 13:15 (at the age of 64-years-old) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure, anxiety and stage 3 kidney disease. Concomitant medications included lisinopril, sertraline and lorazepam, all taken for an unspecified indication, start and stop dates were not reported. The patient experienced cold like symptoms and bloody nose at least once a day on 05Mar2021 at 04:00. There was no treatment received for the events. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore/swollen arm and injection site - started 8 hours after shot, lasted until 10 am 2/17/21 Dizziness - started 8 am 2/16/21, on and off until 11 pm 2/16/21 (bedtime) - had periods of time where standing or sitting resulted in feeling faint as if I may pass out Headache - started 4 pm 2/16/21, lasted until 11 pm 2/16/21 (bedtime) Fever of 99.3° F - started 6 pm 2/16/21 (30 min post ibuprofen 200 mg, APAP250 mg/ASA 250 mg/caffeine 65 mg) lasted until 7 pm 2/16/21 Chills - started at 1 pm 2/16/21, lasted 30 min Fatigue - started 10 am 2/16/21, lasted until 6 pm 2/16/21, slept approximately 6 hours during the day Malaise - all day 2/16/21  All symptoms had completely resolved when I woke up on 2/16/21 except residual soreness at the injection site.  I took APAP 1000 mg every 5 to 6 hours starting at 7 pm 2/15/21 (including the middle of the night). Last dose 2 pm 2/16/21. Ibuprofen 200 mg taken at 5:30 pm 2/16/21
Within 5 minutes had pulse 160 and bp 180/100;  five minutes after receiving the Moderna vaccine. The reaction lasted about 15 minutes and resolve without any medication or intervention.  Reports she ?felt like garbage ?the rest of the day.  Local medics are saying that this was an anaphylactic reaction and are refusing to offer the second  vaccine dose .  Patient states she felt more like an ?adrenaline dump? or maybe an ?infusion reaction?
Softball sized rash and lump on patient's arm below the injection site that spread to her forearm. She states that it is painful and she is starting to get dizzy. I recommended Benadryl but patient said she had been taking it already and it was not helping.
Tongue getting a tiny bit swollen; Her voice became a little raspy; A little difficulty breathing and had to take a deep breath; A little while later her teeth began to chatter which she had not experienced since she was a child; Very lightheaded/Dizziness; Some mild anxiety; It felt like an allergic reaction and it could have been more severe, but it was very mild; This is a spontaneous report from two contactable physician (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch no: not reported/ lot number: FC3183, Expiry Date of BioNTech Covid 19 vaccine was unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 27Aug2021 19:00 (at the age of 65 years) as dose 1, single for covid-19 immunization. Medical history included Bladder infections, that was a long time ago about 20 years ago and she had the wheals all over her body she looked like a lizard, her teeth was began to chatter which she had not experienced since she was a child. The patient previously took Nitrofurantoin, an antibiotic for bladder infections and skin wheals. The patient concomitant medications was not reported. On 27Aug2021 the patient experienced tongue getting a tiny bit swollen, her voice became a little raspy, a little difficulty breathing and had to take a deep breath, a little while later her teeth began to chatter which she had not experienced since she was a child, very lightheaded/dizziness, some mild anxiety, it felt like an allergic reaction and it could have been more severe, but it was very mild. Foe AE there was no need to visit emergency room. Therapeutic measures were taken as a result of the events. Outcome of the events was recovering.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between all the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 01-MAR-2016 the patient was vaccinated with improperly stored ROTATEQ (lot # L029615, expiration date 15-MAY-2017, dose was unknown) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Days 1 & 2 experienced arm soreness. Days 3-5 experienced daily headaches that turned into migraines (on days 4 &5); pain in left wrist; pain in upper arm (below injection area), pain in left shoulder socket (joint pain), and pain in left arm pit (experienced these issues all day long). Day 6 only experienced pain in left wrist and pain in left shoulder socket (joint pain).; experienced both all day long. Day 7 and so forth have no experienced any further issues.
profound fatigue, myalgias, arthralgias, intermittent chills for the 6+ weeks since her second dose
Pt recvd 1st dose of Hep B vax 21MAR91 & on 27MAR91 pt devel nausea, fatigue, & abd cramping; 2 days later devel erythematous rash on elbows, hand, buttocks, & upper legs & a petechial rash on legs; exp diarrhea, joint pain, WBC count 3.8;
Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 08JUN2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB and, oral, ROTATEQ. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Patient called, stated her right arm was painful and swollen in the area where she got her chicken pox vaccine.
This spontaneous report was received from a patient of unknown age and gender (who was also a physician) via field representative referring to self. The medical history and concurrent conditions of patients was unknown. On an unknown date the patient restarted series with GARDASIL lot, dosing details and route unknown and it was reported time between doses was spaced out too long (inappropriate schedule of vaccine administered). Concomitant medications were not reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
sore arm in shot location (both shots); headache (first shot); This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient had her 2nd COVID-19 dose and had no symptoms of any kind except for sore arm in shot location (both shots) and a headache (first shot) reported on an unspecified date. But she believed it was due to high pressure front coming into their area. She stated that she would like to be part of your 3rd dose COVID-19 vaccine trials if possible. The outcome of both the events was unknown.  Follow-up attempts completed. No further information expected.
He has developed redness of left lateral thigh where he received Prevnar and Hepatitis A vaccines yesterday.  Areas is red and swollen and warm.   No fever.  It it tender. He had Ibuprofen 3 hours ago.  Redness is not worsening.    He is able to walk.   He is still using it.   He is refusing cold compresses.   He dislikes cold. No breathing difficulty.   Eating fine.  Not fussy.
anaphylaxis with stridor and diffuse wheezes. No rash, GI symptoms. Received epinephrine, bronchodilators, IV steroids, histamine blockers, epinephrine drip. ICU admission
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (dose administered more than 12 hours post puncture) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 10, 2022, at 9:30 am, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 10, 2022, patient administered expired product (dose administered more than 12 hours post puncture). At the time of the report, administered expired product (dose administered more than 12 hours post puncture) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, the vial was left out on the counter overnight (it was not refrigerated), and opened on Feb 9, 2022, around 2:15 pm. They gave one dose out of it on Feb 10, 2022, around 9:30 in the morning. Post puncture, the vial was stored at room temperature. The vial did not undergo any temperature excursions.
This spontaneous report was received from a physician and refers to a 2 patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 08-SEP-2016, the patients were vaccinated with a dose of improperly stored PROQUAD (incorrect product storage), lot number L032760, expiration date 24-FEB-2017, (dose, route and anatomical location were not reported). There was no concomitant medication reported. No adverse reactions were reported. Additional information has been requested.
Sore arm, redness, swelling and itching at injection site. Lasted several days (about 4) Fever, aches and flu symptoms - Lasted 12 hours.
States feeling like her head was burning and itching. States hair has been steadily been falling out starting 2 weeks post vaccine and continuing over the past two months.
Daptacel dose was administered to a patient and realized after giving it that it had expired with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from a other health professional received on 06-May-2022.  This case involves a 15-month-old male patient who reportedly was administered Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] dose and realized after giving it that it had expired with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB Vaccine CONJ (TET TOX) (ACTHIB) for Immunization.  On 02-May-2022, the patient received suspect Daptacel vaccine at dose 0.5 ml once (lot C5732AA, expiry date: 24-Apr-2022) via intramuscular route in the left vastus lateralis for prophylactic vaccination (expired product administered, latency same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
slight fever; headache; achiness; This is a spontaneous report from a contactable consumer (patient) reported in response to non-Healthcare Professional letter sent. A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264, Expiration date: unknown) intramuscular, administered in left arm on 06Mar2021 at 09:15 am (age at vaccination was 39 years) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for headache from 13Feb2021 to 13Feb2021 and scopolamine aminoxide taken for vertigo from 15Feb2021 to 18Feb2021. The patient did not have any past medication history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3302, Expiration date: unknown) intramuscular, administered in left arm on 13Feb2021 at 09:15 am (age at vaccination was 38 years) as dose 1, single for COVID-19 immunization and experienced vertigo, nausea/nauseous, could not sit up or stand without falling down/unable to be upright for much more than 30 mins at a time, felt weak and foggy feeling. The patient underwent lab test which included COVID-19 test: negative on 19Feb2021. The patient was advised by her doctor to move forward with her 2nd dose. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Mar2021, the patient experienced a headache and slight fever, achiness the night of 2nd dose but was normal by day 2. The outcome of the events was resolved on 08Mar2021.   No follow-up attempts are needed. No further information is expected.
The client notified RN that 2 days after the first COVID vaccine Pfizer he developed chest pain and tightness that lasted about 20 minutes. The client denied any dizziness, shortness of breath, fluttering, or palpitations. The client didn't take any medications or follow up with a provider regarding the symptoms. The client denied any chronic conditions or medications. The client reports a history of an anaphylaxis after consuming shellfish. The client reports a history of chest pain that he attributes to vaping nicotine.
local rxn 2% to tetramune;10cm across, 7cm down, 31cm around thigh;
I have not had a menstrual cycle since the beginning of May 2021. I have also had multiple out brakes of cold sores on my lip since the vaccine. It was very rare for me to get them in the past maybe once a year if that. Now, since June 2021 I have had at least 1 outbreak every 3 months.