chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day of vaccine, headache, feeling of fainting, weakness, feeling of being nauseous.  Felt better after eating.  Next day, felt very weak, had headache in forehead and eye area, bit of dizziness.   Throughout day arm got feeling bad and extremely painful with long sleeve on.  Could not move arm due to pain.   Got a bruise in the puncture area, 2 finger underneath got very hard and slightly red, not rash but raised and hard.  Throughout the next day, was going away, and through the night able to raise arm normally, but still had bump and redness until Sunday.  Still slightly red, but has lessened and almost gone, but still has bruise which is not unusual for her.  Also had itching and was painful to scratch, could only lightly touch.  All has resolved.
Received  first shot of pfizer covid vaccine on monday and then the next developed burning when urinating; Believes it is a bladder infection; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 66year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first shot of pfizer covid vaccine on Monday and then the next she developed burning when urinating. She believed it was a bladder infection as it was ongoing so she went to her HCP for follow up and was prescribed antibiotics. Reporter confirmed she was reporting this as a potential side effect of the vaccine, also confirmed she has no medical inquiry. There was no PQC present. The outcome of the events was unknown.    No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
This patient had a rash on her face and upper chest area, it was itchy, and she had watery eyes. The patient took Benadryl and it resolved.
Infant was given Dtap, Hep B-IPV combo vaccine, PCV 13, rotavirus vaccines and an accidental additional Hep B vaccine instead of Hib vaccine. No adverse effects child doing well.
Metallic taste post injection Fever 102 degrees (by 8pm eve of shot) Tylenol only reducing fever to 101 Severe chills/shakes Insomnia  Confusion Dizziness Tachycardia  (125 bpm) persistent the first night) Loose stools Incontinence
Information has been received from a registered nurse concerning a 21 year old female patient who on an unspecified date as a child was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown).  It was reported that the patient had an asthmatic allergic reaction after vaccination and had to be taken to the emergency room.  Subsequently, the patient recovered from asthmatic allergic reaction on an unspecified date. There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/6/2009. Follow up information was received from the R.N. who reported that was not a medication they gave in their office. She was unaware of any the details about this patient. Additional information is not expected.
No additional AE; temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 07-APR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, dose and route were not provided; frequency-5; lot# was T028139 and expiration date was 15-FEB-2022) involved a temperature excursion for prophylaxis (product storage error). No additional adverse event was reported (no adverse event).        The administered dose involved in a temperature excursion at - 58 degree Fahrenheit (F) to 5 degree F (9.5 F) for 0 hours 45 minutes 0 seconds and 11 degree F for 1 hour 0 minutes 0 seconds. There was a previous temperature excursion at 9.5 degree F for 0 hours 45 minutes 0 seconds. It was detected by a data logger.   This is one of the 7 cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA002470: US-009507513-2104USA002475: US-009507513-2104USA003266: US-009507513-2104USA003268: US-009507513-2104USA003265: US-009507513-0503USA00121:
patient c/o swelling to lips and swelling under eyes . treated with hydroxyzine 2mg tid
On Friday, January 8, 2021, I woke up with diarrhea. By 5:00 AM, I was throwing up (multiple times) and had diarrhea. I then began to develop muscle aches and chills with a low grade temperature. I ran a low grade temperature (as high as 100.4) on and off all day on January 8, 2021.
heart palpitations; muscle twitching; spasms; high blood pressure; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (heart palpitations), MUSCLE TWITCHING (muscle twitching), MUSCLE SPASMS (spasms) and HYPERTENSION (high blood pressure) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 003J21-2A) for COVID-19 prophylaxis.     The patient was not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient had no allergies and no medical history.  Previously administered products included for COVID-19 prophylaxis: COVID 19 Vaccination (Dose 1 and(lot number 067F21A) site of administration; left arm) on 11-Jan-2022. Past adverse reactions to the above products included No adverse event with COVID 19 Vaccination. Concurrent medical conditions included Low blood pressure.    On 15-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations), MUSCLE TWITCHING (muscle twitching), MUSCLE SPASMS (spasms) and HYPERTENSION (high blood pressure). At the time of the report, PALPITATIONS (heart palpitations), MUSCLE TWITCHING (muscle twitching), MUSCLE SPASMS (spasms) and HYPERTENSION (high blood pressure) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: it was close to 140/mid-to-upper 90s.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient had concomitant medication include blood pressure medication that patient took once a day, It was reported that the patient's symptoms started about 3 months after the second vaccine. Before the vaccine, he had really low blood pressure, but after the vaccine, it's been really high. It's been recorded at each doctor visit where it's been significantly higher. The last time, it was close to 140/mid-to-upper 90s. Prior to the vaccine, it was 100-110/high 50s to low 60s. Patient went to the emergency room and prescribed a muscle relaxer, called Flexeril. Patient went to the emergency room about two weeks ago.
Information has been received from a health professional concerning approximately 20 patients who were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #659148/1382U).  Subsequently, the patient's experienced swelling and pain at the injection site, fever, chills and severe arrhythmia.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  A lot check has been requested.  Swelling at injection site, pain at injection site, fever, chills and severe arrhythmia were considered to be disabling.  Additional information has been requested.
administered expired doses of DAPTACEL with no reported adverse event; Initial information was received on 22-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA235929 (CLUSTER), 2023SA258195 (CLUSTER), 2023SA257557 (CLUSTER), 2023SA258504 (CLUSTER) and 2023SA258195 (CLUSTER).  This case involves a 1 years old female patient who was administered expired doses of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] 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 (HIB) for Prophylactic vaccination.  On 18-Aug-2023, the patient received a 0.5 ml, total (once) dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: C5893AA, expiry date: 21-Jun-2023, strength; standard) via intramuscular route in left thigh for Immunisation.  On 18-Aug-2023 the patient was administered expired doses of daptacel with no reported adverse event (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.
This spontaneous report as received from a health care worker concerning to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored VAQTA (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse symptoms were reported. The temperature excursions that were reported for VAQTA was supported excursion with in-house stability data. The outcome of the events was unknown. The causality of the events with VAQTA was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a practice manager (healthcare worker/nurse) refers to a 70 year old female patient with chronic obstructive pulmonary disease (COPD) and coronary artery disease. The patient had no drug reactions or allergies. On 11-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, once, subcutaneous, lot number J014810, expiration date 21-FEB-2015. Concomitant therapies included SENOKOT, CRESTOR, PRILOSEC, AMITIZA, SYNTHROID, isosorbide dinitrate, ADVAIR, SYMBICORT and DULCOLAX. On 12-MAY-2014, the patient developed a rash at the injection site that was red, hard and "blistering in the center". The reporter didn't know if this reaction caused significant disability. The patient had discomfort and had missed work because of this. The patient sought medical attention: the patient was seen by a physician on 14-MAY-2014. The physician prescribed CLARITIN and MEDROL dosepack for treatment and instructed the patient to call back if the reaction spreads or she develops a fever. The practice manager called the patient on 15-MAY-2014 and the patient's arm was still swollen and sore. The outcome of patient has discomfort and has missed work because of this and rash at the injection site that was red, hard and "blistering in the center" was unknown. The outcome of her arm is still swollen and sore was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the event of discomfort and missed work because of this was considered to be disabling. Additional information has been requested.
I had the slight headache and sore arm when I first woke up, but it didn?t keep me from working in my studio.  By noon I realized my head was hurting more and I was making mistakes, so I quit for the day.  No soon had I cleaned up and left my head started really banging and I felt like I had a really bad sunburn all over.  I didn?t want anyone or anything to touch me.  Even the clothes I was wearing irritated my skin.  I had to lay down and felt nauseous,, and I had a steadily increasing fever.  For someone who rarely breaks 97 F on my oral thermometer, reaching 101 was not expected.  I was confused and not making sense.  For example I told my husband he was the cat calling the canary black. He laughed at my mixed metaphor, saying you mean the pot that calls the kettle black.  I dozed, but didn?t really sleep.  Around midnight I realized the headache was easing up and my temperature dropped to 99.5F.   When I woke in the morning the temperature and headache ere gone and all that remained was about a 6 inch diameter red ring around the injection site, but the episode was basically over.  Thanks for listening.
Patient was scheduled to receive the bivalent moderna booster covid vaccine but was provided with improper dose.  Received 0.25ml rather than 0.5ml.
patient called and says  that she has been itching on different parts of her body. She says that she got her pfizer vaccine on Friday and then had body aches in her joints and other areas on Saturday. she stated that she had no other symptoms. She then began to have itching on her hands Sunday morning and from Sunday to Thursday she has had itching in different areas of her body sometimes being over the entirety. She mentioned that she has taken benadryl and I asked about loratadine and she said she had already tried that as well. I then said that with the itching being in different areas that hydrocortisone may be hard to pinpoint so it would be better that she see a dr for perhaps oral steroids. I asked if she had trouble breathing throat closure or hives and she states she does not. I told her I would document and she said she would see a dr for treatment.
Tested positive for the Covid virus; Tested positive for the Covid virus; This is a spontaneous report from a contactable nurse.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient received the first dose of the vaccine on 29Dec2020 and four days ago, he tested positive for the Covid virus (02Jan2021). The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Test positive for the Covid virus found 4 day following the vaccination, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.
Pt recv vax on 5-4-98; on 5-6-98 pt exp local reaction at injection site w/ erythema approx 5 cm x 6.5 cm; area also hot to touch.  Pt tx= Augmentin 457 mg 2x a dy.  As of 5-7-98 event still ongoing.
Patient stated normal side effects starting the evening of vaccination; sore arm, chills achy progressed to swollen and itchy face, eyes, lips. denies any breathing issues. At time of report still having symptoms.
A SMALL PATCH OF BLISTERS BEGAN ON HER  LOWER RIGHT ARM, , LEFT HAND.; BODY ACHE; FEVER; This spontaneous report received from a patient concerned a 54 year old female. 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, intramuscular, batch number: 204A21A, and batch number: 204A21A expiry: /JUN/2021) .5 ml, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced body ache. On 14-JUN-2021, the subject experienced fever. On 28-JUN-2021, the subject experienced a small patch of blisters began on her lower right arm, left hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fever on 15-JUN-2021, and had not recovered from a small patch of blisters began on her lower right arm, left hand. This report was non-serious.
3 days of fever; 7 days of feeling hurt, "nasty" and bad; 7 days of feeling hurt; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included post herpetic neuralgia and antiviral regimen.   On 16th November 2020, the patient received the 1st dose of Shingrix. On 17th November 2020, 1 days after receiving Shingrix, the patient experienced fever, pain and malaise. On 20th November 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain and malaise were recovered/resolved.   It was unknown if the reporter considered the fever, pain and malaise to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced fever, malaise and feeling hurt, nasty and bad. 1 week before vaccination, patient was on antiviral medication for post herpetic neuralgia. At the time of reporting, patient still had post herpetic neuralgia. The reporter did not consent to follow up.
rash reappeared and is itchy; Red and sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Red and sore arm) and RASH PRURITIC (rash reappeared and is itchy) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INTERFERON from 18-Mar-2021 to an unknown date for Multiple sclerosis, CALCIUM PANTOTHENATE, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (B VITAMIN COMP [CALCIUM PANTOTHENATE;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) from 18-Mar-2021 to an unknown date and COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) from 18-Mar-2021 to an unknown date for Stress.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Red and sore arm). On 18-Mar-2021, the patient experienced RASH PRURITIC (rash reappeared and is itchy). On 12-Mar-2021, PAIN IN EXTREMITY (Red and sore arm) outcome was unknown. At the time of the report, RASH PRURITIC (rash reappeared and is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Added FUP email from patient
fatigue Narrative:  Experienced 9 days of increased fatigue starting the day of the vaccination. Did not inhibit her from working, but she did not feel motivated to exercise (typically exercises 5-6 days/week). Denied confusion, lightheadedness, dizziness, syncope or any other concerns for immediate allergic reaction or anaphylaxis.
Injection site is very bruised and swollen with some pain. Ice applied and Tylenol given
This spontaneous report was received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis, (route, dose, lot# and expiration dates were not reported). No adverse effects were reported. There were no previous temperature excursions; the data logger reported: "traceable Min. and Max." There was no Product Quality Complain (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA012322: US-009507513-1612USA013204: US-009507513-1612USA013205: US-009507513-1612USA013207.
dizzy, hot flashes, nausea, weird taste/feeling in mouth/throat, very tired. Very mild when i woke up at 7 then became progressively worse resulting in leaving work around 11:20. At home working but ready to take a nap.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 years old male patient who was injected FLUBLOK while he received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (also reported as 12-Nov-2019), the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1814, expiry date- 30-Jun-2019 via unknown route in the left deltoid. Concomitant medication includes MENVEO received on the same day. It was a case of actual medication error due to inappropriate age at vaccine administration. There were not side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt's mother called to report that pt broke out in hives approx. 1 hr after the administration of the vaccines. Pt's mother also stated she would take pt to the ED to be checked out.
My PCR test came back POSITIVE for COVID-19; POSITIVE for COVID-19; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 09Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Then patient had no adverse reactions or any sign that got an immune response from the Vaccine. The patient's husband had no vaccine as of yet, and he contracted COVID-19 being positive on 23Feb2021. On February 25, patient woke up extremely sick. On an unspecified date the patient experienced pcr test came back positive for covid-19 (vaccination failure),covid-19. On an unspecified date he patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events were unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information provided, the causality between the events and the suspect product BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number was not reported),  is possible.