chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, historical condition and concomitant therapy were unknown. In approximately November 2017, the patient was vaccinated an expired dose of M-M-R II (albumin status rHA, lot # L043704, with expiration date 04-NOV-2017) (dose, dose#, route of administration were not reported) for prophylaxis, which was reconstituted with sterile diluent (manufacture unknown) (lot # N014021 with expiration date at 04-AUG-2019). M-M-R II had not gone through any temperature excursion. No adverse effects reported.
This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 lot # M030380 and expiration date on 01-FEB-2019 and lot # M021407 with expiration date on 30-APR-2018 (dose and route of administration were not reported) for prophylaxis. The doses of GARDASIL 9 were exposed to a temperature excursion of 35 degrees Fahrenheit (°F) during a time frame of 1 hour and 15 minutes, which was detected by the data logger. There was no prior temperature excursion, no adverse events were reported and no product quality complaints were present. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA011946: US-009507513-1709USA013505.
tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: EW0172) at the age of 41 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "tired". The event "tired" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue.
Soreness at site and muscle ache. Flu like symptoms and overall body discomfort and ache. Woke up out of sleep that night to vomit.
Approximately 3 minutes post-vaccination, the patient suffered a witnessed tonic-clonic seizure, which lasted less than a minute.
She presents emergency department with chest pain that started 24 hours ago.  She states that when she woke up yesterday she was experiencing central chest pain, no radiation.  She states that if she applies pressure to her right anterior intercostal muscles with her hand, the pain is alleviated.  The pain is worsened if the patient leans forward, alleviated by leaning back.  Pericarditis Diagnosis management comments: Chest pain, story is concerning for pericarditis.  Cardiac workup is negative and given it has been 24 hours since onset of chest pain, a single cardiac workup is sufficient rule out cardiac disease.  D-dimer is negative.  Chest x-ray, no acute cardiopulmonary abnormalities.  Patient feels significantly improved after Toradol.  Story remains consistent pericarditis, patient is given outpatient NSAIDs, I advised follow-up with primary care provider within the next week as may need further testing.  Advised good return precautions in case of worsening chest pain, difficulty breathing, any worsening condition.  Patient discharged in stable condition.
Patient presented to ER with redness and swelling below the injection site and runs to the axilla almost similar to a lymphangitis.
vertigo; Red injection reaction on arm; Fever; Chills; Myalgia; Maybe nausea; Not feel well; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included autoimmune disorder. Previously administered products included Shingrix (On unknown day patient received 1st dose).   On 16-JUN-2023, the patient received the 2nd dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Red injection reaction on arm), fever (Verbatim: Fever), chills (Verbatim: Chills), myalgia (Verbatim: Myalgia) and nausea (Verbatim: Maybe nausea). On an unknown date, the patient experienced vertigo (Verbatim: vertigo) and feeling unwell (Verbatim: Not feel well). The outcome of the injection site erythema, fever, chills and myalgia were not reported and the outcome of the nausea and vertigo were not resolved and the outcome of the feeling unwell was resolved (duration 5 days).   It was unknown if the reporter considered the injection site erythema, fever, chills, myalgia, nausea, vertigo and feeling unwell to be related to Shingrix.     It was unknown if the company considered the injection site erythema, fever, chills, myalgia, nausea, vertigo and feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR088326   Additional Information: GSK Receipt Date: 23-JUN-2023 The patient received second shot and experienced baseball size, red injection reaction on arm. Fever, chills, myalgia,maybe nausea (vertigo patient so that comes and goes - the nausea). For 5 days patient did not felt well.  Patient went to work on Tuesday.  Patient 2nd Shingrix shot was on the prior Friday. Patient had a history of Autoimmune disease. The reporter did not consented to follow up.; Sender's Comments:  US-GSK-US2023AMR088326:same patient, diffrent dose
Throat issues; Nervous; Sinus/allergy infection; Allergy symptoms; Chills(shaking so bad she couldn't get warm); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Throat issues), NERVOUSNESS (Nervous), SINUSITIS (Sinus/allergy infection), HYPERSENSITIVITY (Allergy symptoms) and CHILLS (Chills(shaking so bad she couldn't get warm)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol high and Multiple allergies (multiple medication allergies, reported mycins.). Concomitant products included ESTRADIOL, ROSUVASTATIN and VITAMINS NOS for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 04-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat issues), NERVOUSNESS (Nervous), SINUSITIS (Sinus/allergy infection), HYPERSENSITIVITY (Allergy symptoms) and CHILLS (Chills(shaking so bad she couldn't get warm)). The patient was treated with AMOXICILLIN for Sinus infection, at a dose of 875 milligram and VITAMIN B12 NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (Throat issues), NERVOUSNESS (Nervous), SINUSITIS (Sinus/allergy infection), HYPERSENSITIVITY (Allergy symptoms) and CHILLS (Chills(shaking so bad she couldn't get warm)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test negative: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medication reported During follow up patient noticed they did not add in that a week after receiving the Moderna vaccine she had really bad chills that lasted 2 hours and it did not stop until she got into a bathtub with hot water. She stated when she went to the doctors, the PA gave her a B12 shot and she thinks it might have been a reaction to receiving the B12 shot.   This case was linked to US-MODERNATX, INC.-MOD-2021-029603 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Non-significant FU-Email updated. On 06-Jul-2021: Non-Significant Follow Up - Contact information updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-029603:Crosslinked case
1-20-2021 8:30PM - sore arm 1-21-2021 8:00AM temp 98.1 sore arm only 2:25PM temp 99.8  Headache, cold, skin sensitive to touch, fatigue, weak 4:30PM temp 101.3  Nurse checked: BP 120/80     O2 - 98 4:50PM Took 2 Reg. Tylenol Temp went down to 98.1 by 98.1 but started going up to 98.8 by 10:30PM when took 2 reg. tylenol early evening started having heart palpitations Jan. 22 and 23rd, 2021 Temp gradually going back to normal without Tylenol. Still having fatigue, weak, heart frequently skipping beats, feeling short of breath with activity Jan. 27, 2021 saw family doctor because of continued heart palpitations and shortness of breath with activity.
Tightness in chest while breathing, insomnia, pain at injection site, fever, intense shivering, chills, headache, congestion, coughing.
debilitating intermittent headaches that comes and goes; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (debilitating intermittent headaches that comes and goes) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (debilitating intermittent headaches that comes and goes). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (debilitating intermittent headaches that comes and goes) had not 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 relevant concomitant medications were reported. Patient needs to be in a dark room to help herself feel better. Patient had taken Tylenol (paracetamol) and Motrin (ibuprofen), as treatment medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a physician concerning a 2 month old male, with no medical history and no allergies, who, "about 10 to 12 days ago", on approximately 10-FEB-2008, was vaccinated with a first 2 ml oral dose of ROTATEQ. Concomitant vaccines included "routine vaccinations". "Soon after receiving the vaccine", on approximately 10-FEB-2008, the patient experienced stomach pain and gas. "About two days after receiving the vaccines," on approximately 12-FEB-2008, the patient recovered. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. Additional information has been requested.
Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient developed a mass under her skin at injection site. the patient's mass persisted. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information have been received from a physician concerning a 26 year old female with a Sulfonamide (BACTRIM) allergy to who on 19-FEB-2007 was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (Lot #655126/0087U). Subsequently, on 29-MAR-2007 the patient called her physician and reported that she had developed a mass under her skin at injection site. On 02-APR-2007 the patient had an ultrasound of the area which was negative. The patient reported that she also had pain in the area in her triceps when working out. It was reported that after the use of heat/massage the area increased in size from approximately the size of  dime to an area the size of a quarter. On 07-MAY-2007 the patient was seen by the physician who reported that the lump felt like an injection site granuloma <10mm. The physician reported that there were no deformities, color changes or tenderness with deep palpatation. At the time of this report the patient had not recovered. Additional information has been requested.
Half dollar sized welts broke out on chest: 5 welts that would fit into half dollar circle: fiery red, itchy. No pain.  Just started to dry up and loose inflammatory response starting Monday 9/2
Pt developed hives right after vaccinations and for 1 week has raspy voice - increased vomiting, crankiness and episodic hives. Was treated with 3 days of prednisone and cetirizine.
Patient complained of an itching tongue, throat, and lips to the clinic nurse.  No objective symptoms noted.
Had my advanced shot but still got them/suspected vaccination failure; still got them; mild pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had advanced Shingles shot but still got them but not as bad without the vaccine and reported that it was lasted over a month with mild pain, but he/she could not imagine them with real pain. The patient reported that get your shot if you had not and reported that felt sorry for those anti vacciners. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding, primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. As the number of doses received was not confirmed hence single suspect was captured with blank dose number.
No symptoms.  I just stood up and walked across the room, I didn't know what was going on.  No Warning.  Then I crumbled up against the kitchen table chair.  I than fell to the floor and could not get up myself.  I was in no pain.  I was awake at all time.  I stayed on the floor until my daughter arrived home from the grocery store a half hour later.  I did not feel I needed to go to the Dr.    Later that night while trying to sleep I had to go to the bathroom and urinate about 3 time during the night.    I
16 days post vaccination I broke out into truck hives with occasional spot of arms and legs. Hives stayed for 4 days start to finish and were unaffected by benedryl and other antihistamine drugs. Cortisone creams also had no effect. Hives were raised but not red and did not bother me other than visually.
Patient got Pfizer bivalent dose on 1/5/23. Came back 3/4/23 and reported that she had experienced oozing and tenderness on spot of injection from Pfizer bivalent. She said the oozing occurred not too long after 1/5/23 and it continued for weeks. As of 3/4/23 there was no more oozing, but there is a covered blister-like formation exactly on the spot of injection- subjective from the patient.  Patient reported that she did not see a healthcare provider about this ADR until now, because she thought it would get better.  On 3/4/23, we told patient to see primary care physician as soon as possible for further treatment options, and that everything would be reported to VAERS as this is a first time this kind type of ADR was reported to us.
Patient was limping, got fever overnight, woke up limping. Leg swelling from knee to upper thigh with redness all over the top of the leg. It became obvious around 10:00 am. He was seen by the clinic at 5:00 pm, who advised Zyrtec, and possibly Keflex if no response to Zyrtec.
redness, edema, tenderness at sites of immunization and fussiness.  Sx onset several hours after immunization.  Redness, edema and tenderness at Right anterior thigh sites of administration of DTAP #2 and Prevnar #2 immunizations
Low-grade  fever, headache, muscle soreness, injection site pain, chills (despite not feeling cold).
My menstrual cycle came on 5 days early but when it came on I had large blood clots. I?ve never had my cycle come on early. I take birth control tablets the correct way and the Saturday when I started bleed, I had taken my tablet at my regular time that day.  I also usually don?t have heavy periods at all so the amount of blood so early was unusual for me.
Localized hives on abdomen and lower extremities 4-6 hours after administration.  Persisting over 2 days.  Also with diarrhea, fussiness x 2 days, progressing.  Reevaluated in office on following day.
This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 28-NOV-2017, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N001488, expiration date 12-JUL-2018 (route of administration was not reported) for prophylaxis. The vaccine had been reconstituted with properly stored sterile diluent. The vaccine experienced a temperature excursion of 23.2 degrees Fahrenheit for 8 hours. There were no previous temperature excursion reported. The digital data logger was involved in recording the temperature excursion details. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA006828: US-009507513-1801USA002139: US-009507513-1801USA002137.
7 hrs after shot I felt exhausted & drained. Then at 11:00pm , I was extremely exhausted, drained & felt fatigued with chills. I went to bed about 1 hour feeling like this. Then around 3 or 4:00 am I had a bad headache. I called hospital if I could take advil or something. I did, it  mostly went away.  I was not sore in my arm, that felt fine. But the area was raised & red, sore just right at the shot site only.
Itching of both lower legs for 2 weeks only at night...no rash.  Steroid dose pack given two weeks later, with 24 hour itching of whole body itching...still ongoing, with horrible rash.  Steroid  cause weakness of the feet, which requires rehab.  As of today, she received multiple prescribed creams and itching prevention pills.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients received improperly stored doses of M-M-R II (HSA (human serum albumin)), lot # L034731 with an expiration date of 09-SEP-2017 and lot # L039613 with an expiration date of 08-OCT-2017 (doses and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccine underwent the temperature excursion of 9 degrees Celsius for 30 minutes which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA003654: US-009507513-1701USA014067: US-009507513-1701USA014075.
tinnitus; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 61-year-old patient received BNT162b2 (BNT162B2), on 11Jun2021 at 16:08 as dose 1, single (Lot number: EW0182) at the age of 61 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia", start date: 18Apr2018 (ongoing); "Neuropathy", start date: 21May2020 (ongoing); "Hypogonadism", start date: 02Aug2018 (ongoing); "Hypertension", start date: 10Apr2018 (ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset Jul2021, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient had no prior vaccination within 4 weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300262471 Same reporter/ patient/ product, different dose/ event.;
my mouth stays sore; my tongue is very sore; I don't know the name of it (tonsils) it hurts; When I Swallow It Is Uncomfortable, Hurts -Burns; my gums are sensitive; my lips are cracking/splitting; This is a spontaneous report from a contactable other hcp. A 78-years-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included chronic myeloid leukaemia from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included bosutinib (BOSULIF, Formulation: tablet, Expiration date: 31Dec2023) 200 mg, daily via oral taken for chronic myeloid leukaemia from 04Feb2021 to an unspecified stop date, ibandronate sodium (BONIVA) 150 mg tablet, chondroitin sulfate, glucosamine sulfate, turmeric [curcuma longa rhizome] 100 % powder, omeprazole 20 mg capsule DR, acetylsalicylic acid (ASPIRIN EC) LO-DOSE, ONE DAILY FOR WOMEN, fish oil, cyanocobalamin (VITAMIN B-12), potassium, duloxetine hydrochloride (CYMBALTA) and denosumab (PROLIA) 60 mg/ml syringe taken for unspecified indication from an unknown start date. It was reported that, on an unspecified date, my mouth stays sore. My tongue was very sore. I used sensodyne toothpaste and it sets me on fire. I used listerin to rinse my mouth and it hurt so badly. Behind i don't know the name of it (tonsils) it hurt. When I swallow it was uncomfortable, hurts - burns. My gums were sensitive. My lips were cracking/splitting. I don't know if it was from the medication or the covid vaccine. Per patient it started about 3 weeks ago. Patient's MD was not aware, the pharmacist advised the patient to let her prescriber know to see what they suggest going forward. The pharmacist informed the patient that he had never heard of this being a side effect of the covid vaccine. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.