chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NO APPETITE; DIZZINESS IF STOOD UP, OFF AND ON; UNBEARABLE MIGRAINE; FEVER; SEVERE HEADACHES; NAUSEA; VERY FATIGUED; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included rare blood disease (porphyria), and concurrent conditions included mild asthma, obese, hypothyroid, psoriasis, and vitamin deficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included sulfasalazine for psoriasis, cyanocobalamin for vitamin deficiency, folic acid, and levothyroxine. On 07-APR-2021, the subject experienced severe headaches. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced very fatigued. Laboratory data included: Body temperature (NR: not provided) 101 F. On 07-APR-2021 22:00, the subject experienced fever. On 07-APR-2021 22:30, the subject experienced unbearable migraine. On 10-APR-2021, the subject experienced dizziness if stood up, off and on. On an unspecified date, the subject experienced no appetite. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from fever on 08-APR-2021 02:00, and the outcome of severe headaches, nausea, very fatigued, dizziness if stood up, off and on, no appetite and unbearable migraine was not reported. This report was non-serious.
approx 2mos p/vax pt exp mild viral sx w/scattered red lesions on scalp, back, legs , 4-5 lesions, pustular in nature & surrounded by red wheal, as well as 15-20 addl small reddened papules erupting on back & legs.
Severe sepsis without septic shock. He completed 5 days of broad-spectrum antibiotics and was stable for discharge to  home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from a male patient, who was a pharmacist, referring to himself. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2011, the patient completed a series of unspecified number of doses of RECOMBIVAX HB injection (dose, route of administration, lot number and expiration date were not reported). On an unknown date in 2017, he had an unspecified tests performed that revealed low titers for hepatitis B antibody. On an unknown date, the patient experienced an unspecified event, which required a treatment with double lung transplant. At the time of the report, the patient was awaiting the transplant and it was not reported when the procedure would be performed. The outcome of the events was unknown. The relatedness between the events and RECOMBIVAX HB was not reported. Upon internal review, the event requiring the treatment with double lung transplant was considered to be medically significant.
Well demarcated erythema, hive like, no discharge, no signs of cellulitis
psoriasis came all the way back/bumps on buttocks, groin, back of legs, thighs, elbows and spotty/rashes on back, elbow, ankles, private parts, and buttocks; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis came all the way back/bumps on buttocks, groin, back of legs, thighs, elbows and spotty/rashes on back, elbow, ankles, private parts, and buttocks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 029L20A) for COVID-19 prophylaxis.     The patient's past medical history included Psoriasis (had a couple of patches, approximately 3 years ago). Concomitant products included VITAMIN D3, VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PSORIASIS (psoriasis came all the way back/bumps on buttocks, groin, back of legs, thighs, elbows and spotty/rashes on back, elbow, ankles, private parts, and buttocks). At the time of the report, PSORIASIS (psoriasis came all the way back/bumps on buttocks, groin, back of legs, thighs, elbows and spotty/rashes on back, elbow, ankles, private parts, and buttocks) outcome was unknown.            Patient had psoriasis symptoms as bumps on buttocks, groin, back of legs, thighs and rashes on back, elbow, ankles, private parts, and even buttocks. Patient also had it on elbows and it was spotty. It was usually on there for a bit, then after awhile the dead skin pealed off. They also mentioned that a lot of elderly people are getting rashes and maybe not connecting the dots that it was due to the Moderna COVID-19 vaccine. Patient received pfizer vaccine as first booster on 27-Dec-2021 (batch lot number fe3594). patient had dead skin on face. but it was caused by the sun and did not look like psoriasis. Patient had this procedure done by dermatologist, regularly and used liquid nitrogen that dermatologist sprays on patient face. Patient would be going to going to see dermatologist again next month. Patient got covid in august of this year (2022). it was a mild case, though.   This case was linked to MOD-2022-674526 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2022: Live Follow up received contains reporter added and narrative Updated.
no adverse event; PROQUAD had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 24-AUG-2023, the patient was vaccinated with a 0.5 mL dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # X011437 exp date 18-JUL-2024) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Marked swelling, redness, heat, and induration measuring 7 x 10x 1.5 cm surrounding injection site. (no pain, just itching). Gradually subsided over next 4 days.
Patient didn't feel good after receiving vaccine, thought she might faint, but never did. I asked patient to lay down, blood pressure was taken and was normal. Offered to call 911, but patient refused. Used ice on patient's forehead as patientt was clammy. Patient was offered water or gatorade, but didn't want.  Patient felt better and sat up. She drank some water from her own water bottler. Pt remained in pharmacy area for 45 min while I monitored her blood pressure and heart rate. After patient reported that she felt good and was ready to go, I advised patient not to drive, but rather have a friend pick her up. Room mate came to pick patient up. Patient reported that she felt fine when she left. I followed up this afternoon with a phone call to check on her, she did not pick up and I left  message. She has not called back by the end of the business day.
patient received an expired dose of Adacel with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age male patient who received an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On 25-Oct-2022, the patient received 0.5ml, 1 X(once) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation was unknown, lot C5788CA and expiry date: 14-Oct-2022) via intramuscular route in the right deltoid for Immunization.  On 25-OCT-2022 the patient developed a non-serious event of patient received an expired dose of adacel with no reported adverse event (expired product administered, Latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the regulatory agency. 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 was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of VAQTA (dose, frequency, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that an unspecified number of patients (no patient information was unknown) were administered VAQTA, which was improperly stored outside the temperature storage range listed in the product inserts, on an unknown date. No adverse effects reported. Additional information has been requested. These case is one (1) of four (4) reports from the same source.
Body aches, swollen and sore lymphnodes near injection site, headache persistent for more than 3 days
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 57-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that, there had been no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that, no adverse reactions were reported by the patient.  No treatment medication was provided.
Full body generalized rash starting about 12 days from receiving third moderna dose. Rash produces occasional hives/welts and does not improve with prednisone or medrol. Intensely itchy.  Also has produced  dermatographia  as an effect.
This spontaneous report as received from a pharmacist refers to a 79 year old female patient. On 20-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot# unspecified), intramuscular. The patient "currently" had soreness at the injection site as well as a red hard bump that looked like a mosquito bite at the injection site. The outcome of soreness the events was reported as not recovered. The patient had sought medical attention via calling the pharmacy. Additional information has been requested.
Patient states abdominal pain  with nausea, vomiting, and diarrhea that began 3/27/2021. States symptoms have become worse since 2nd dose on 4/23/2021. Sought medical care on 5/10/2021.
Ran temperature of 103 11/03/02; broke out in 5 lesions. Received Benadryl and lesions disappeared.
NO adverse event, no appear harm to patient. But patient did received their booster dose too early. Original series of Pfizer covid vaccine given on 8/27/21 (lot# EW0179) and second dose on 9/17/21 (lot# EW0191). Patient is NOT severely immunocompromised and did not qualify for a third dose. Patient was given a "booster" dose on 12/20/21 when should have waited until mid-March 2021 (guidance at that time was 6 months until booster dose).
Pain; redness; swelling to over 2in still after 60 hours; This is a spontaneous report from a contactable consumer (patient) via regulatory authority.   A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Mar2021 09:00 (lot number: EN6206; expiry date: unknown) at the age of 31-years-old, as dose 1, single, for Covid-19 immunisation. Medical history included Covid. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with Covid-19 prior vaccination. On 10Mar2021, at 15:00, the patient experienced pain, redness, swelling to over 2 in still after 60 hours. The patient did not receive treatment for the events. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. The patient has not been tested for Covid-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
Fever up to 102, chills, improved the next AM with temp to 100. Spoke with doctor on phone. Told to call or go to ER if worsening reaction. Take extra strength TYLENOL as needed.
This spontaneous report was received from a medical assistant via a company representative and refers to a 16 month old female patient. No pertinent medical history, concurrent conditions or drug reactions/ allergies were reported. On 19-MAY-2016, the patient was inadvertently vaccinated with GARDASIL 9, in her thigh (the dose, dosage number, route of administration, lot # and expiration date were unknown). No concomitant medications were reported. Despite being vaccinated with GARDASIL 9 at such an age, no adverse effects were reported. The patient did seek medical attention. This vaccination occurred since the reporter did not know what medication was intended to be administered to the patient. Nevertheless, no product quality complaint was involved. Additional information has been requested.
Woke morning following injection with typical reported symptoms (chills, fever, muscle aches), upon waking the next day (7/13/21) I began to experience dizziness upon bending over or looking up. I?ve experienced vertigo in the past, but I?ve practiced relief exercises to no avail. I?m still suffering from this dizziness as of the date submi thing this report. (8/10/21)
0955Pt reported "thickness on her throat" denied SOB, no other symptoms. BP 137/79, P-75, Spo2 96% RA. 1007 Pt reported feeling much better, P- 69, Spo2 98%. Pt instructed to watch for SOB, difficulty swallowing and call her doctor/911 for emergencies. Pt was evaluated by EMT's. Pt left at 1008, RN.
First dose was given on 11Nov2019 / second dose had not been given yet at time of call; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable.  The age group was selected as an adult as per vaccine indication. Till the time of reporting, the patient had not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consent to follow up.
Call from mom, stating that pt has not felt well since vaccine received 4/12/18. C/o nausea and headache that started "a few days after the shot."
pt recvd flu vax & c/o muscle soreness & nausea for 2 wks;
The patient is a 56 y.o. male who presents to the Emergency Department with cough and SOB for 2-3 days. The patient states he was vaccinated with the johnson and johnson COVID-19 vaccine two weeks ago. He denies any vomiting diarrhea, fevers, leg swelling, or chest pain. The patient additionally denies being around any sick contacts or any recent travel.     The patient is a 56 y.o. male evaluated for cough and SOB for 2-3 days. Possibility of pneumonia. I have lower suspicion for PE, however his oxygen saturation is less than 94%, so we will obtain a D-dimer. I have lower suspicion for ACS. Will also check COVID swab to rule out COVID despite recent vaccination.
Patient told that her arm at injection site was sore, red, warm and painful and got celulitis. Currently her MD has prescribed KEFLEX.
severe reaction; my BP went to 240/190; heart rate of 120 causing a trip to; This case was reported by a other health professional via interactive digital media and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event, increased blood pressure and heart rate increased. The patient was treated with intravenous fluid (nos) (Intravenous Fluids). On an unknown date, the outcome of the adverse event and heart rate increased were unknown and the outcome of the increased blood pressure was recovered/resolved.   It was unknown if the reporter considered the adverse event, increased blood pressure and heart rate increased to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient had severe reaction to the first vaccine. The patient's blood pressure went to 240/190 with heart rate of 120 due to which patient visited emergency rrom. The hospital administered medicines through IV to reduce blood pressure. The patient concerned about whether similar reactions occure with 2nd vaccine.
At 2:45 patient began to have a barky cough.  Then seemed to have trouble breathing and seemed like he was choking on mucus.  Then had episode of clear emesis.  Mother called clinic at 3:15 and was told to take him to urgent care immediately.  At about 3:30 while driving in care he became unresponsive in car seat.  Did not open eyes to having name called or leg shaken by mother.  He had normal skin color.  She pulled over and called EMS.  When ambulance arrived he was slightly responsive, pink, but not interactive.  He was given oxygen and a Duoneb treatment.  Became more responsive while getting neb.
Severe swelling and redness that ran down the arm to the elbow; Severe swelling and redness that ran down the arm to the elbow; Patient couldn't lift arm; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA; lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date after the use of the product, the patient experienced severe swelling and redness that ran down the arm to the elbow. Patient could not lift arm and had to take BENADRYL for 3 days. The outcome of the events was unknown.  No follow-up attempts are possible, information on the batch number could not be obtained. No further information is expected.
Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: En5318; Expiration date was not reported) on 22Jan2021 (10:45) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included multiple (MS), blood clots and pulmonary embolism. Concomitant medications included rivaroxaban (XARELTO) and omeprazole. The patient previously took clarithromycin (BIAXIN), and had drug allergies. The patient was not pregnant at the time of vaccination. On 23Jan2021 (16:00), the patient had nausea. The patient did not receive any treatment for the event, nausea. The outcome of the event, nausea, was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.
necrotic blister surrounding erythema and induration one day after administration and lymphangitic streaking proximally two days after administration
Chest pain, possibly costochondritis related to Asthma, but d-dimer tests returned with flag and elevated/abnormal WBC and platelet count suggesting mild local (non-systemic) infection. Emergency Room visit to rule out PE in relation to d-dimer tests. Broad spectrum immune support to treat mild infection systems. Still resolving, but better.
Occurred during the couple days after the immunization occurred. Caused a rash on the left arm / shoulder that was inflamed.
When they put the shot it's been hurting me ever since then; This is a spontaneous report from a contactable consumer.  A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for  COVID-19 immunization.  Medical history included diabetes and headache from an unknown date. Concomitant medication included metformin (MANUFACTURER UNKNOWN) for diabetes.  On an unspecified date, the patient reported that " when they put the shot it's been hurting me ever since then " with outcome of unknown. Details were as follows: Patient indicated that when he  got the shot, everything was good but when they put the shot it's been hurting ever since then. There were no lab tests, or treatment given for the event.  The outcome of " when they put the shot it's been hurting me ever since then " was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .