chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within a week of the vaccination, she was tired, and she had a few nose bleeds (that were hard to stop). Her gums started bleeding when brushing her teeth a few weeks after the vaccine. She then started having high fevers around October 31, 2006,(103, 104, 105)and was eventually hospitalized on November 7, 2007, after a blood test revealed that her blood platelet count was down to 16,000. She had two chest x-rays that were normal. She was diagnosed as having high fever, a low platelet count (platelets got as low as 7,000), and low red blood cells count (which resulted in anemia). While hospitalized, she was twice treated with IVIG that caused her platelet count to rise. She also received intravenous antibiotic treatments that she did not respond to. She was also given Tylenol and later Motrin while hospitalized to control the fever. She is now taking Prednisone for a short period. In addition, she is taking iron pills and Protonix (to protect her stomach from the affects of the steroid medicine). While hospitalized, she also had a CAT Scan (of the head) and ultrasounds of her abdominal area (tests were normal).  12/06/2007 MR received for DOS 11/7-17/2007 with D/C DX:  Evan's Syndrome. Presented to local ED with fever x days, thrombocytopenia and anemia. Pt initially developed cough, rhinorrhea, fatigue and fever. Treated symptomatically for suspected viral infection.  Pt developed increasing fatigue and difficulty leaving bed.  Seen again by PCP with labs and CXR done.  Admitted for further w/u of FUO and thromobcytopenia.  PE (+) for purpura of the external ear, lip ecchymosis (blood blisters), violaceous scaly skin patches involving the malar eminence, and upper extremities. Started on abx and IVIG PMH: Skin disorder x 1.5-2 yrs c/w granuloma annulare.  Rash on face/cutaneous lesions c/w Lupus.  Constipation.  Recurrent sinus infections. Pt developed nausea, dizziness and blurred vision and had a near syncopal episode.  New onset RUQ pain on day 8 with increased LFTs.  Multiple consults by Heme/Onc, Rheum, GI, Neuro and ID. DX of Evan's Syndrome on Day 10 and tx with steroids begun to be continued and F/U as outpt. Per 60 day follow up: She is still experiencing low platelets, which is being controlled by steroid usage (presnisone). 1/15/2010 Patient rec'd other vaccine, hep A on 7/31/08 and she had to be readmitted to the hospital she experienced hair loss, skin rash, fevers, low plackets and joint pain.
pt recvd vax & staring c/o h/a, tingling all over, not feeling well; BP 150/100 then 160/100, inc weakness, prostration; tx w/DPH, to ER
Onset 24 hours from vaccine, left parotid gland became hard, tender and enlarged.  Patient denied dental pain, there is only one intact molar on the lower jaw and it was not tender, and the gum was normal. Patient denied fever, chills, n/v, difficulty swallowing or any other new complaints.  No axillary or cervical lymphadenopathy, no pain with percussion of tooth.  Skin temperature and color over the parotid were normal.  Pain with opening mouth, but able to open it to a normal amount.  Over the course of 5 days the parotid returned to normal.  Patient sucked on lemon candies .  Patient denied dry mouth.  She took less than 5 doses of acetaminophen, and used heat and ice for comfort.  No antibiotics were given.  Patient opted not to seek in person care at her physician's office since the ventilation is very poor there and she didn't want to remove her mask. CO2 reaches 3000 ppm in the exam room and is consistently over 1200 ppm in the waiting room.  They do not use portable HEPA. (It would be really great if CDC addresses ventilation in physician offices.) I examined my Mother via video and my sister performed the exam in person by my instructions.
A report has been received from a Health Professional concerning a 32 year old, Female subject who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST started on an unknown date. The registered nurse reported that they gave a patient expired FLUMIST which started on 11-Dec-2013. The patient has not reported any adverse symptoms. The outcome of the event of GAVE A PATIENT EXPIRED FLUMIST is unknown. The report was considered to be non-serious by reporter.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; VOMITING; This spontaneous report received from a health care professional concerned a female of unspecified age, ethnic origin and race. The patient's height, and weight were not reported. The patient's past medical history included flu virus, and concurrent conditions included disabilities and compromised immune system. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection, suspected clinical vaccination failure, vomiting and not being able to hold down water or food. ER (Emergency Room) balanced her system, just like they had to when her crones like symptoms' had caused many times, for many years, without any viral infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and not being able to hold down water or food was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210632001-Covid-19 vaccine ad26.cov2.-Suspected Clinical Vaccination Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Cervical lymphadenopathy with 2x2 cm node,  shoulder pain.
Spoke with pt mom and she said pt was fine no fever/no rash/no swelling.
Initial information has been received from a physician concerning a 4 year old patient who on 24-SEP-2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Follow up information has been received from a medical assistant who indicated that the patient was inadvertently vaccinated with Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (MSD).  She indicated that this was due to "stupidity and human error".  No reaction with the patient was noted.  Additional information is not expected. This is in follow-up to report (s) previously submitted on 12/21/2007. Follow-up information was received concerning a female with no pre-existing allergies, birth defects of medical conditions whowas vaccinated subcutaneously in the left arm at approximately 11:00 AM with a first dose of ZOSTAVAX (Merck (lot#656859/0357U). There was no illness at the time of vaccination. Additional information is not expected.
Extreme fatigue and weakness, chills, headache, loss of balance (fell over several times 01/15 through 01/17). Symptoms resolved (except for some lingering weakness) on 01/18/2013 upon waking up at 6:30 AM.
w/in 24 to 48 hrs post vax experienced n,v, fever & diarrhea which spontaneously remitted in 2 days;
39 year old male patient was administered a pediatric dose of Engerix-B; 39 year old male patient was administered a pediatric dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 39-year-old male patient who received HBV (Engerix B pediatric) (batch number EP724, expiry date 14-MAR-2024) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (RECOMBIVAX).   On 30-AUG-2023, the patient received the 2nd dose of Engerix B pediatric. On 30-AUG-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 39 year old male patient was administered a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: 39 year old male patient was administered a pediatric dose of Engerix-B).  The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-Aug-2023 Pharmacist reported that the patient was administered a pediatric dose of Engerix-B and this was the patient's second dose in the series.   In looking at the record, the reporter stated that it appeared that the patient also received a pediatric dose for their first dose on 26th July 2023, and that the first dose was Recombivax. However, the lot number for that dose he provided (E42X5) pulls up in batch master as 20 mcg dose of Engerix-B.   At the time of reporting, no additional doses had been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Fever, including aching muscles, skin sensitive to touch, lasted a full day. Red around injection site, noticed on day 2 (too concerned with fever on day 1 to notice if it was red then).
pain in arm pit; numbness and tingling in right arm; numbness and tingling in right arm; This is a spontaneous report from a contactable other hcp.    A 32-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot Number: EM9810 expiry date was not reported) dose 1 via an unspecified route of administration at Arm Right on 06Feb2021 at 09:30 as a single dose for covid-19 immunisation. Medical history included polycystic ovaries (PCOS). Concomitant medication included levonorgestrel (MIRENA). The patient did not have known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Feb2021 at 19:30, patient experienced pain in arm pit, numbness and tingling in right arm. The patient did not receive any treatment for adverse events. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.  Follow-up attempts completed. No further information expected.
Itching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided. No concomitant medication was reported
Rash around the injection site; Arm is sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site rash (Verbatim: Rash around the injection site) and pain in arm (Verbatim: Arm is sore). The outcome of the injection site rash and pain in arm were not reported.   It was unknown if the reporter considered the injection site rash and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the injection site rash and pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-MAR-2023 This case was reported by patient via interactive digital media. The patient just got his/her first dose of the new shingles shot. The patient's arm was sore and had a rash around the injection site, and would need his/her next one in July. The patient stated that, It was better to be safe than sorry. get your shot. Follow up was not possible, as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Ringing of the ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: ER8733) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose,, Lot: EN6207, Left Arm), administration date: 12Mar2021, when the patient was 64 years old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Apr2021, outcome "not recovered", described as "Ringing of the ears".  Additional information: Patient had the First Dose on 12Mar2021 around 9 or 10AM. She had the Second Dose on 02Apr2021 at around 9 or 10AM, the ringing in the ears started after the second dose, it was a few days after maybe 3-4 days, possibly the Monday after the second dose. Patient didn't write it on a calendar, she didn't believe it when it happened, but she has the ringing in the ears since then. The ringing happens in both ears, sometimes its both ears, sometime its alternating. Sometimes she'll wake up and noticed its only in the right ear, sometimes left.  No follow-up attempts are possible. No further information is expected.
Fever 104.5 degrees-24 hours after immunizations and had a febrile seizure. Local reaction at KINRIX injection site. (Keratosis)
Received dose2 at 3:38pm. Lip swelling at 3:53pm. pt given Benadryl 25mg. MD evaluate the patient as per nursing staff the lip swelling was already improved.  Vitals 177/110 mmHg rechecked again after 15 minutes came down to 130/102 mmHg.  During MD exam there was no tongue swelling no lip swelling.  Advised patient to monitor symptoms at home and to call 911 if she develops any worsening above symptoms. Work note given to the patient and advised to follow-up with her primary doctor in 2 to 3 days. 1650-Friend here to drive her. Friend also educated on S&S of severe reaction and when to call 911. Per MD ok to DC home. BP164/82, P76+, R18, O2 sat 100% RA 1700- DC with friend in stable cond.
Left upper thigh red with slight edema, 10cmx10cm circle area, warm to touch. Cool, wet cloth on area next 2-3 days.
anaphylaxis/The patient experienced swollen eyes, swollen lips, developed hives and shortness of breath; The patient received the first dose of GARDASIL 9 on 15-MAY-2018 and received the second dose on 16-JUN-2019; This spontaneous report was received from a physician (also reported as a director of quality) via a field employee referring to a 12 years old male patient. The patient's pertinent medical history included history of Guillain-barre syndrome folloing influenza vaccination. Information about drug reactions/allergies and concomitant medication was unknown.  On 15-MAY-2018, the patient was vaccinated the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, route, lot # and expiration date were unknown) for prophylaxis (reported as recommended for 11 and 12 year olds).  On 16-JUN-2019, the patient was vaccinated with the second dose in the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1602281has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 21-JUL-2021, dose detail, route were unknown) for prophylaxis (reported as recommended for 11 and 12 year olds) and the patient did not receive any other vaccinations at that day (inappropriate schedule of product administration).  On 19-JUN-2019, the patient experienced anaphylaxis, swollen eyes, swollen lips, developed hives and shortness of breath. The patient was hospitalized for an unknown amount of time. Information about treatment given, lab diagnostics/studies was unknown by the reporter. The outcome of event was reported as recovered. The causality assessment between anaphylaxis and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was determined as related.   Upon internal review, the event of anaphylaxis was determined to be medically significant.
Rash body, period (period after 1 year without having it) tachycardia, symptoms of strong anxiety and depression, dizziness, low blood pressure, body pain.
Flu like symptoms, 18 to 20 hours after injection. Feverish, chills, muscular aches, sensitive skin, headache. Symptoms disappeared approx. 15 hours after appearing.
FAINTING AT NIGHT; LOW BLOOD PRESSURE AFTER VACCINATION; LIGHT SENSITIVITY; BLISTER LIKE LESIONS ON HER ARMS AND LEGS; INCREASED THIRST; ITCHY EYES; BURNING EYES; WATERY EYES; This solicited report received from a patient via PPSIMM000648: SPP Fee For Service Sponsored Communication- Humana concerned an elderly female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient was treated with Tremfya (guselkumab) (solution for infusion in pre-filled syringe, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for psoriatic arthropathy.  The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported frequency time 1 total prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case Concomitant medications included betamethasone, citalopram, (Dicyclomine) dicycloverine ,fenofibrate, folic acid, hydrochlorothiazide, methotrexate, nystatin, olmesartan medoxomil ,propranolol, and simvastatin for unknown indication. On an unspecified date, the patient experienced fainting at night, light sensitivity, blister like lesions on her arms and legs, increased thirst, itchy, burning and watery eyes and low blood pressure after vaccination. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with guselkumab was not reported. The patient had not recovered from low blood pressure after vaccination, light sensitivity, blister like lesions on her arms and legs, increased thirst, fainting at night, itchy eyes, burning eyes, and watery eyes. The reporter provided no causality assessment. Company causality between Covid-19 vaccine ad26.cov2.s, and fainting at night, low blood pressure after vaccination, light sensitivity, blister like lesions on her arms and legs, increased thirst, itchy eyes, burning eyes, and watery eyes was not related; and between guselkumab, and fainting at night, low blood pressure after vaccination, light sensitivity, blister like lesions on her arms and legs, increased thirst, itchy eyes, burning eyes, and watery eyes was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210860397-COVID-19 VACCINE AD26.COV2.S-FAINTING AT NIGHT. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210860397- GUSELKUMAB-FAINTING AT NIGHT. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Nausea; vomiting; Metallic taste; Headache; migraine; didn't have an appetite; lost taste, lost the sense of taste; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported a 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176) via unspecified route single dose for COVID-19 immunization on 08Jan2021, 10 am, at 38-year-old. Medical history was not reported. Concomitant medication included: celecoxib (CELEXA) 10 mg for an anti-depressant; alprazolam (XANAX) 0.25mg three times a day. Once the patient took that second vaccine, she had the metallic taste and had some headache and migraine at that time (08Jan2021). When the patient got the vaccine, within one minute, she started getting her usual migraine on the right side of head (08Jan2021), that was pretty much instantly. She didn't have an appetite (Jan2021), she only vomited when she ate. She had nausea and vomiting, it was about 2 o'clock that afternoon (08Jan2021, 2 pm). Every time she ate, she vomited and lost taste, lost the sense of taste. The patient was still nauseated (Hence, ongoing checked for nausea) and she hadn't tasted anything. She hadn't drink or ate anything yet this morning but last night her taste was starting to come back. But she still couldn't identify something. No treatment received. Action taken for BNT162B2 was not applicable. Outcome of the event nausea was not resolved, outcome of the other events was unknown.
5 minutes after vaccine patient had mild hives, sensation of throat itching and watering eyes. Given Benadryl 50 mg IM injection. Recovered fully.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M018810, expiration date 28-MAY-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 33.4 degrees Fahrenheit for 60 hours and 35 minutes. There were no previous excursions. It was unsure if data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA002635.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA310637 same reporter. This case involves a 20 years old patient who received 0.5 mL dose of suspect vaccine MENACTRA lot 05712AA, expiry date: 11-Oct-2018 via unknown route in the right deltoid on 07 Nov 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included IPOL for Immunisation; FLUZONE QUADRIVALENT for Immunisation; and VARICELLA VACCINE for Immunisation. It was actual medication error due to Expired vaccine used. It was reported that the patient who received an expired MENACTRA vaccine. It was unknown if any adverse event was occurred. 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 and Module VI of the 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. Documents held by sender: none.
Left deltoid is swollen and red, pt advised to use warm compresses, prescribed sulfamethoxazole.