chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEELING PRETTY GROSS; AWFUL SLEEP; ACHY; FEELING CRAPPY; FREEZING; FULL BODY CHILLS; TIRED; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced feeling crappy. On APR-2021, the subject experienced achy. On APR-2021, the subject experienced freezing. On APR-2021, the subject experienced full body chills. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced awful sleep. Laboratory data included: Body temperature (NR: not provided) 102 F. On 07-APR-2021, the subject experienced feeling pretty gross. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from awful sleep on 06-APR-2021, had not recovered from headache, and the outcome of feeling crappy, tired, freezing, full body chills, fever, achy and feeling pretty gross was not reported. This report was non-serious.
Edema and erythema right arm (MCV4) vaccine site 50x50. Tender to touch. Injection site feels warm.
Patient had first shingrix vaccine administered in the afternoon, and the next day woke up with a gouty attack in his right foot.
SO I had an enlarged lymph node in the left side of my neck which was causing visible swelling in that area. It was larger than the corresponding lymph node on the other side of my neck. At this point my DR is just going to keep watching but I got an ultrasound in April and will repeat another one in July to see.
Within 24 hours I experienced a cold sensation in my right eye which worsened to a persistent dull pain / numbness.  I had a complete eye exam on 08/23/2021 which was normal.  No treatments were prescribed.  After two weeks symptoms improved in the right eye, however there is mild ongoing discomfort in both eyes now.  Within 24 hours I also experienced severe brain fog and had pains in my head which felt like blood clots in the parietal lobe.  I had sensations of feeling ill,  feverishness, cold-sweats, and headache for about two weeks which gradually declined.  Approximately 6-weeks later, I began experiencing Approximately 8-9 weeks after the first dose, I  began experiencing a persistent dull pain / numbness / burning sensation in my spinal cord around the thoracic region.  I had X-rays and blood work performed on 11/19/2021 related to these symptoms which were normal.  It feels like inflammation in the spinal cord and is unaffected by movement.    I have no medical history with respect to the reported events  these are all brand new phenomena.
Received Trumenba in 2021 and then got Bexsero; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of interchange of vaccine products in a 19-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) (batch number CW3115) for prophylaxis.   Previously administered products included Menactra (received Menactra on 22nd June 2021 in left arm).   On 16-MAY-2023, the patient received Bexsero (intramuscular, left deltoid) .5 ml. On 22-JUN-2021, the patient received the 1st dose of TRUMENBA (intramuscular, right deltoid) .5 ml. On 16-MAY-2023, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: Received Trumenba in 2021 and then got Bexsero). The outcome of the interchange of vaccine products was 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: 16-MAY-2023 The medical assistant called on behalf of nurse practitioner. The patient was a healthy person. The patient had no other conditions. The patient had no investigations. The patient had no other products. NDC number and expiry date of Trumenba was unknown. NDC number and expiry date of Bexsero was not Provided. The reporter reported a patient received Trumenba in 2021 and then got Bexsero at the day of reporting. The reporter called to find out if there was any reaction or if the series for Trumenba needs to be restarted. The agent was able to address inquiry. The reporter confirmed contact details upon transfer. The patient received only one dose of Trumenba. It was not administered at their office, it was administered at a different physician office.  The reporter only had lot number to provide. The patient received Trumenba and then got Bexsero, which led to interchange of vaccine products.
Patient called 4/21/21 at 2:08 pm and said at 6 AM he woke up in a "pool of sweat" and started vomiting + chills. No fever. He vomited once and has been nauseous since. He feels very dizzy. He was walking down hallway, and he "blacked out" and fell down the stairs. He said he did not hit his head, but the right side of body hurts, as well as chest, after the fall. He said this pain is causing some difficulty breathing. He said his dad witnessed the fall. When asked if the pain is severe, he said "yes". He was told that if he's experiencing "severe" pain after a fall, accompanied with difficulty breathing, he should seek medical attention. He was told he can contact his Dr. for a second opinion first, if desired. Otherwise, it was suggested he check his BP, if possible, sit with head between knees or lay down with feet propped up and NOT walk around if feeling dizzy. He was advised to stay hydrated and introduce bland foods first to see if he can tolerate solid food. He was told he can take whatever oral pain reliever he normally takes that he's allowed to take if needed. Patient will report back to me.
COVID symptoms began 3/16, positive test 3/19, hospital admission 3/22, death 4/1
Presented to ER on 8/2/06 with c/o weakness and dizziness. Had received 2L of IV fluids prior to being transported to hospital by medic. Reported that he had been at the clinic earlier in the week with similar c/o. Review of systems noted patient reporting weakness and lethargy as well as muscle soreness and HA. Temp 100.1 at time of visit. Diagnosed as smallpox vaccine reaction. Received IV Toradol for HA, quarters x 24 hours, patient education on inflammatory process related to smallpox vaccination.
No additional AE/PQC reported; the caller said the ROTATEQ expired on 07-MAR-2022 and was administered on 09-MAR-2022; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 09-MAR-2022, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally for prophylaxis (strength and lot number were not reported, expiration date: 07-MAR-2022) (expired product administered). There were no prior temperature excursions. No additional adverse event/product quality complaint were reported. No additional information was provided.
I felt really tired and fatigued the night after. I couldn't sleep well at all. I also got excess skin on my head and face and it started peeling very badly. It started itching and burning. I never had this happen to me before. I tried using dandruff shampoos, but nothing worked. I talked to my doctor over the phone and he said it was my immune system overreacting to the vaccine. He told me that if it gets worse than I will get medicated.
Left arm warm, mild swelling and redness along left inner upper arm and going down left inner lower arm. No signs of infection/fever. Able to use arm.
Patient states on 2/10/2015 arm started swelling by 2/11/15 large area of swelling and open red spot in middle.  Saw PCP who treated with icon on area 20 minutes 2-3 times per day, silvadene daily on wound and cover with bandaid, prednisone taper pack.
Patient was less than 12 years old when she received her primary series of Pfizer vaccine. Mother had physically completed and signed consent form with incorrect date of birth 06/05/2009. Father came with patient's passport on 12/23/2021 requesting to correct date of birth on records.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, pertinent medical history and concomitant therapies were not reported. The registered nurse stated that an unspecified number of improperly stored doses of GARADASIL (lot# reported as K009505, expiration date: 20-FEB-2016) (dose, frequency and route of administration were unspecified) were inadvertently administered to the patients for prophylaxis on unknown dates. No adverse events were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
Patient said on 10/29 she developed fever and aching-10/30-sweating and fever-11/1 large hives and itching-she is taking Benadryl and using hydrocortisone topically-vaccine was the only thing that was different so she is concluding that vaccine is the cause of the hives and itching--advised her to contact her doctor tomorrw 11/3. She contacted us today 11/2.
10:01am lightheadedness, weird. Patient advised to wait 15 min for reassessment but left. 150/100, HR 84, 154/100, BS 123, O2Sat 97%.
UTI; low back pain; back spasms; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (low back pain), MUSCLE SPASMS (back spasms) and URINARY TRACT INFECTION (UTI) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 052E21A) for COVID-19 vaccination.     The patient's past medical history included Bladder disorder (history of bladder problems).   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced BACK PAIN (low back pain) and MUSCLE SPASMS (back spasms). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). The patient was treated with IBUPROFEN for Adverse event, at a dose of 800 milligram three times a day. At the time of the report, BACK PAIN (low back pain), MUSCLE SPASMS (back spasms) and URINARY TRACT INFECTION (UTI) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Urine analysis: abnormal (abnormal) Urine test shows UTI.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient called her HCP who encouraged her to come in to the clinic as she had a history of bladder problems.   She was prescribed a muscle relaxant, pain medication, and antibiotics for her symptoms. She had not yet taken these medications and still needs to get them from the pharmacist. No concomitant medication were provided.
Cellulitis; Arm started swelling; Arm was red; Arm was tingling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Arm was red) and PARAESTHESIA (Arm was tingling). On 22-Jan-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis), PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Arm was red) and PARAESTHESIA (Arm was tingling) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 16 Jan 2021, the patient's arm started swelling, and it was red and tingling. The redness started traveling down her arm.  On 22 Jan 2021, the patient went to urgent care and was told she had cellulitis. She was told it was bacteria getting into the skin from the way it was administered. She stated the physician who gave her the injection, cleaned the area before the shot was given. She reported that she was to pick-up antibiotics that day (22-Jan-2021). The patient states she definitely has an infection in the arm.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Queasiness, shaking/jittery, blurry vision, dry mouth, racing heart.
I had my period twice in April 2021 19 days apart.  The first dose in March I had mild symptoms for 3-4 days; headache, chills, low fever, fatigue. After second dose 4-12-21 I had the same symptoms for about 2 days.
Chills and sweats, upset stomach/diarrhea, muscle and joint pain, fatigue. I was not able to take Tylenol or aspirin because I am taking a steroid. Symptoms went away after about 36 hours.
Next morning dizzy and nausea 4 days then less for 6 days and then nausea and dizzy since then.; Next morning dizzy and nausea 4 days then less for 6 days and then nausea and dizzy since then.; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Apr2021 at 09:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Mar2021 at 13:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. On 06Apr2021 at 07:00, the next morning after the vaccination, the patient experienced dizzy and nausea 4 days, then less for 6 days and then nausea and dizzy since then. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and meclizine as treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy and nausea were not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported moderate-severe pain in shoulder after receiving immunization. He reported to the pharmacy on 1/31/2018 that he was still experiencing pain at the injection site and is unable to lift his arm above his shoulder. He had an appointment with Dr. in January and said it was likely due to the vaccine being administered too high. He suspected blood was pooling in the patient's shoulder and recommended an MRI.
Information has been received from a medical assistant concerning a 2.5 month old female with no post medical history and no known drug allergies who on 07/03/01 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy on 07/03/01 included poliovirus vaccine, Hib conjugate vaccine (Acthib hemophilus B conjugate vaccine) and diptheria toxoid/pertussis vaccine/teta. There were no concomitant medications or current illness. On approximately 07/05/01, the infant experienced a slight temperature elevation and was "cranky". Unspecified medical attention was sought. Additional information has been requested.
After getting vaccine, patient felt  her upper arm numb and her fingers were tingling. Pharmacist on duty told her to call her PCP and her PCP sent her to ER where she was not prescribed any medication as they told her that it might have hit her nerve. she has scheduled an appointment with  her PCP for follow up.
Patient developed headache, vomiting, epistaxis with vomiting and bloody diarrhea the day after the Pfizer injection. Symptoms lasted for 2 days. Mother brought to ED for nausea and was concerned symptoms would return and worsen.
None stated.  This is in follow-up to report(s) previously submitted on 05/25/2010: This document was sent in error by the clinic. There was no adverse event. Please discard. Clinic has been retrained regarding adverse events and completion of VAERS. Per RN.
H/A started day after MENACTRA given.  Headache (1-2 time qd) relieved by TYLENOL.  Temp. 6/21/08-6/22/08 (Temp 99-102).  Vomited once today.
I received a flu shot last week from one of the pharmacists. I had a little tenderness in my left arm from the shot and a little bruising but no cold/flu like symptoms as of Tuesday Sept 17.
patient had heart palpitations for almost a week after getting the shot. she reported it to her primary care md and is going to follow up with them . patient was advised by md to get second covid shot.
Mild discomfort; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received the first dose of  bnt162b2 (BNT162B2, lot number: EL-1283) , via an unspecified route of administration in the left arm (at 51 years of age) on 22-JAN-2021 at 13:00 as a single dose  for Covid-19 Vaccination.  Medical history included hypertension and Hypothyroidism.  Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide, losartan potassium (HYZAAR).  The patient had no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  On 22Jan2021 at 14:30, the patient experienced mild discomfort.  No treatment was given for the event. The clinical outcome of the event mild discomfort was unknown.
Redness on face, both ears, both eyelids and neck; Itchy over redness; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (Redness on face, both ears, both eyelids and neck) and PRURITUS (Itchy over redness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ERYTHEMA (Redness on face, both ears, both eyelids and neck) and PRURITUS (Itchy over redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness on face, both ears, both eyelids and neck) and PRURITUS (Itchy over redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Medical Assistant at a physician office reported that a patient received Moderna vaccine on 07-Apr-2021 and 2 hours post receiving their vaccine dose the patient experienced redness on face, both ears, both eyelids and neck and it was itchy over redness.   Reportedly, the patient took Benadryl for that.  No Concomitant product use was reported.
This is a spontaneous report from a contactable consumer. A 68-year-old female patient received PREVNAR 13, via an unspecified route of administration on 07Nov2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced rash on an unspecified date. Patient reported that the vaccine was not prescribed by a doctor and he got it from a pharmacy. Information on batch number has been requested
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Severe
Moderna COVID-19 Vaccine EUA Red spot "covid arm" appeared on the 20th and had faded away by the 25th.
body aches; flu-like symptoms; chills; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021. The most recent information was received on 14-Jul-2021 and was forwarded to Moderna on 14-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN (body aches), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills). At the time of the report, PAIN (body aches) had not resolved and INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.  No treatment information were provided.  At the time of follow up the patient was in pain.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Updated outcome of the event of body aches.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Additional Details: Pt was sitting for observation and suddenly fell to lateral side. Staff RN and technician responded immediately.
Fluzone Quad 15-16 vaccine manufactured by Sanofi Pasteur, was given to patient in the right arm in the afternoon of 11/03/2015 and immediately the after the vaccine was administered, the site began to swell. An Ice pak was immediately administered to the site and held on for about 10 minutes, after which the swelling went down. Patient was observed for a few minutes and given permission to leave. A follow up call was done to patient's home twice but we were unable to reach patient.
fever-mild evening of 13DEC94,then 15DEC took pt to PMD for cont fever & severe rxn @ site of inj-red,hot,size of baseball;that next AM (5:00 16DEC95) had febrile sz & t105.5 to ER;PMD felt was viral infect not d/t vax;NOS